125742 45 S211 M5 c4591001 A 6mth report cci any malignancy 06aug2021

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 12 15 Documents

21

Document text

CCI_Any malignancy
MedDRA Dictionary Version: 240
Status: ACTIVE
Term Name: CCI_Any malignancy
Code: 90002950
Extension: CCI
Report Date/Time: 06-Aug-2021:02:13:04 
PM EDT
Term Code Level Category Weight Scope
Small cell carcinoma of the cervix 10041057 PT
Small cell carcinoma 10041056 PT
Signet-ring cell carcinoma 10057266 PT
Serous cystadenocarcinoma ovary 10054913 PT
Cystadenocarcinoma pancreas 10065908 PT
Seminoma 10039956 PT
Secretory adenoma of pituitary 10039893 PT
Second primary malignancy 10039801 PT
Scrotal cancer 10039744 PT
Sarcomatosis 10039500 PT
Breast cancer stage IV 10006202 PT
Breast cancer stage III 10006201 PT
Breast cancer stage II 10006200 PT
Breast cancer stage I 10006199 PT
Breast cancer recurrent 10006198 PT
Breast cancer male 10061020 PT
Breast cancer in situ 10006189 PT
Gastric cancer stage II 10017764 PT
Gastric cancer stage I 10017763 PT
Gastric cancer stage 0 10017762 PT
Gastric cancer recurrent 10017761 PT
Gastric cancer 10017758 PT
Ganglioneuroblastoma 10017708 PT
Ganglioglioma 10017701 PT
Gallbladder squamous cell carcinoma 10073068 PT
Gallbladder cancer stage IV 10058283 PT
Gallbladder cancer stage III 10058282 PT
Gallbladder cancer stage II 10058281 PT
Gallbladder cancer stage I 10059317 PT
Gallbladder cancer stage 0 10059316 PT
Gallbladder cancer recurrent 10017619 PT
Gallbladder cancer 10017614 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219759
Gallbladder adenosquamous carcinoma 10073067 PT
Gallbladder adenocarcinoma 10058286 PT
Follicular thyroid cancer 10016935 PT
Follicular dendritic cell sarcoma 10075332 PT
Fibrosarcoma 10016632 PT
Female reproductive tract carcinoma in 
situ 10061154 PT
Fallopian tube cancer stage IV 10016187 PT
Fallopian tube cancer stage III 10016186 PT
Fallopian tube cancer stage II 10016185 PT
Fallopian tube cancer stage I 10016184 PT
Fallopian tube cancer 10016180 PT
Extraskeletal osteosarcoma recurrent 10015852 PT
Extraskeletal osteosarcoma 10015847 PT
Extraskeletal myxoid chondrosarcoma 10073134 PT
Extraskeletal chondrosarcoma recurrent 10015843 PT
Extra-osseous Ewing's sarcoma recurrent 10015764 PT
Extra-osseous Ewing's sarcoma 10015759 PT
Extraocular retinoblastoma 10015831 PT
Extragonadal primary seminoma (pure) 
stage IV 10015816 PT
Extragonadal primary seminoma (pure) 
stage III 10015815 PT
Extragonadal primary seminoma (pure) 
stage II 10015812 PT
Intraocular melanoma 10061252 PT
Intraductal proliferative breast lesion 10073094 PT
Intraductal papillary-mucinous carcinoma 
of pancreas 10073365 PT
Intracranial meningioma malignant 10022770 PT
Intracranial germ cell tumour 10073751 PT
Intestinal adenocarcinoma 10051925 PT
Inflammatory malignant fibrous 
histiocytoma 10073142 PT
Ovarian germ cell embryonal carcinoma 
stage I 10033196 PT
Ovarian germ cell choriocarcinoma stage 
IV 10033195 PT
Ovarian germ cell choriocarcinoma stage 
III 10033191 PT
Ovarian germ cell choriocarcinoma stage II 10033187 PT
Ovarian germ cell choriocarcinoma stage I 10033183 PT
Ovarian germ cell choriocarcinoma 10073262 PT
Ovarian germ cell cancer stage IV 10061897 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219760
Ovarian germ cell cancer stage III 10061896 PT
Ovarian germ cell cancer stage II 10061895 PT
Ovarian germ cell cancer stage I 10061894 PT
Clear cell carcinoma of cervix 10074909 PT
Choroid plexus carcinoma 10067478 PT
Inflammatory carcinoma of breast 
recurrent 10021977 PT
Immune reconstitution inflammatory 
syndrome associated Kaposi's sarcoma 10072796 PT
Hypopharyngeal cancer stage IV 10021049 PT
Hypopharyngeal cancer stage III 10021048 PT
Hypopharyngeal cancer stage II 10021047 PT
Hypopharyngeal cancer stage I 10021046 PT
Hypopharyngeal cancer stage 0 10021045 PT
Hypopharyngeal cancer recurrent 10021044 PT
Hypopharyngeal cancer 10021042 PT
Huerthle cell carcinoma 10066136 PT
Hormone-refractory prostate cancer 10062904 PT
Hormone-dependent prostate cancer 10071119 PT
Hormone refractory breast cancer 10076935 PT
Histiocytic sarcoma 10076876 PT
Histiocytic medullary reticulosis 10068785 PT
HER2 positive gastric cancer 10066896 PT
HER2 positive breast cancer 10065430 PT
Hepatocellular carcinoma 10073071 PT
Hepatoblastoma recurrent 10019823 PT
Hepatoblastoma 10062001 PT
Hepatobiliary cancer in situ 10073074 PT
Hepatobiliary cancer 10073073 PT
Hepatic cancer stage IV 10059325 PT
Hepatic cancer stage III 10059324 PT
Hepatic cancer stage II 10059319 PT
Hepatic cancer stage I 10059318 PT
Hepatic cancer recurrent 10073070 PT
Hepatic cancer 10073069 PT
Hepatic angiosarcoma 10067388 PT
Heavy chain disease 10019350 PT
Head and neck cancer stage IV 10071536 PT
Head and neck cancer stage III 10071537 PT
Head and neck cancer stage II 10071538 PT
Head and neck cancer stage I 10071539 PT
Head and neck cancer 10067821 PT
Haematological malignancy 10066476 PT
Haemangiopericytoma of meninges 10018826 PT
Haemangiopericytoma 10018825 PT
Glottis carcinoma 10018395 PT
Gliosarcoma 10018340 PT
Gliomatosis cerebri 10066254 PT
Glioma 10018338 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219761
Glioblastoma multiforme 10018337 PT
Choroid melanoma 10008773 PT
Choriocarcinoma 10008757 PT
Chordoma 10008747 PT
Chondrosarcoma recurrent 10008738 PT
Chondrosarcoma 10008734 PT
Cholangiosarcoma 10077861 PT
Cholangiocarcinoma 10008593 PT
Cervix carcinoma stage IV 10008348 PT
Cervix carcinoma stage III 10008347 PT
Cervix carcinoma stage II 10008346 PT
Cervix carcinoma stage I 10008345 PT
Cervix carcinoma stage 0 10061809 PT
Cervix carcinoma recurrent 10008344 PT
Cervix carcinoma 10008342 PT
Central nervous system neuroblastoma 10073130 PT
Central nervous system melanoma 10077160 PT
Cardiac teratoma 10057456 PT
Cardiac neoplasm malignant 10061025 PT
Carcinoma in situ of trachea 10007401 PT
Carcinoma in situ of penis 10007384 PT
Carcinoma in situ of eye 10007368 PT
Carcinoma in situ 10061450 PT
Carcinoma ex-pleomorphic adenoma 10077435 PT
Cancer in remission 10065305 PT
Bronchioloalveolar carcinoma 10058354 PT
Bronchial carcinoma 10006417 PT
Breast sarcoma recurrent 10068584 PT
Breast sarcoma 10068582 PT
Renal cancer recurrent 10038390 PT
Renal cancer 10038389 PT
Refractory cancer 10070308 PT
Recurrent cancer 10038111 PT
Rectosigmoid cancer stage IV 10038099 PT
Rectosigmoid cancer stage III 10038098 PT
Rectosigmoid cancer stage II 10038097 PT
Rectosigmoid cancer stage I 10038096 PT
Erythroplasia of lip 10052826 PT
Erythroblastosis 10049466 PT
Epithelioid sarcoma recurrent 10015104 PT
Epithelioid sarcoma 10015099 PT
Epithelioid mesothelioma 10073064 PT
Epiglottic cancer 10084056 PT
Epididymal cancer 10073115 PT
Ependymoma malignant 10014968 PT
Ependymoma 10014967 PT
Endotheliomatosis 10076868 PT
Endometrial stromal sarcoma 10048397 PT
Endometrial sarcoma recurrent 10067064 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219762
Endometrial sarcoma 10057649 PT
Endometrial cancer stage IV 10014741 PT
Endometrial cancer stage III 10014740 PT
Endometrial cancer stage II 10014739 PT
Endometrial cancer stage I 10014738 PT
Endometrial cancer stage 0 10014737 PT
Endometrial cancer recurrent 10014736 PT
Endometrial cancer 10014733 PT
Endometrial adenocarcinoma 10014720 PT
Endocrine neoplasm malignant 10061122 PT
Embryonal rhabdomyosarcoma 10065868 PT
Ear neoplasm malignant 10055017 PT
Ductal adenocarcinoma of pancreas 10073364 PT
Desmoplastic small round cell tumour 10064581 PT
Desmoplastic mesothelioma 10073063 PT
Dermatofibrosarcoma protuberans 10057070 PT
Dedifferentiated liposarcoma 10073135 PT
Cystadenocarcinoma ovary 10054912 PT
Craniopharyngioma 10011318 PT
Conjunctival primary acquired melanosis 10066925 PT
Conjunctival melanoma 10066384 PT
Colorectal carcinoma stage 0 10010038 PT
Colorectal cancer stage IV 10010035 PT
Colorectal cancer stage III 10010034 PT
Colorectal cancer stage II 10010033 PT
Colorectal cancer stage I 10010032 PT
Colorectal cancer recurrent 10010030 PT
Colorectal cancer 10061451 PT
Colorectal adenocarcinoma 10052360 PT
Colon cancer stage IV 10009956 PT
Colon cancer stage III 10009955 PT
Colon cancer stage II 10009954 PT
Colon cancer stage I 10009953 PT
Transitional cell carcinoma 10044412 PT
Transitional cell cancer of the renal pelvis 
and ureter regional 10044411 PT
Transitional cell cancer of the renal pelvis 
and ureter recurrent 10044410 PT
Lip and/or oral cavity cancer 10061523 PT
Linitis plastica 10024520 PT
Light chain disease 10024459 PT
Leptomeningeal myelomatosis 10078282 PT
Leiomyosarcoma recurrent 10024194 PT
Leiomyosarcoma 10024189 PT
Transitional cell cancer of the renal pelvis 
and ureter localised 10044408 PT
Transitional cell cancer of the renal pelvis 
and ureter 10044407 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219763
Tracheal cancer 10044285 PT
Tonsil cancer 10044002 PT
Tongue neoplasm malignant stage 
unspecified 10043966 PT
Tongue carcinoma stage IV 10058433 PT
Tongue carcinoma stage III 10058432 PT
Tongue carcinoma stage II 10058431 PT
Tongue carcinoma stage I 10058430 PT
Tongue carcinoma stage 0 10058429 PT
Tongue cancer recurrent 10071251 PT
Thyroid cancer stage IV 10071030 PT
Thyroid cancer stage III 10071029 PT
Thyroid cancer stage II 10071028 PT
Thyroid cancer stage I 10071027 PT
Thyroid cancer stage 0 10070567 PT
Thyroid cancer recurrent 10072162 PT
Thyroid cancer 10066474 PT
Thymoma malignant recurrent 10043674 PT
Thymoma malignant 10061031 PT
Throat cancer 10043515 PT
Testis cancer recurrent 10069813 PT
Testis cancer 10057644 PT
Testicular yolk sac tumour stage III 10043359 PT
Testicular yolk sac tumour stage II 10043358 PT
Neuroendocrine carcinoma of the bladder 10078341 PT
Neuroendocrine carcinoma 10057270 PT
Neuroblastoma recurrent 10066595 PT
Neuroblastoma 10029260 PT
Nephroblastoma 10029145 PT
Neoplasm malignant 10028997 PT
Nasopharyngeal cancer stage IV 10028792 PT
Nasopharyngeal cancer stage III 10028791 PT
Nasopharyngeal cancer stage II 10028790 PT
Nasopharyngeal cancer stage I 10028789 PT
Nasopharyngeal cancer stage 0 10028788 PT
Nasopharyngeal cancer recurrent 10028787 PT
Nasopharyngeal cancer 10061306 PT
Nasal sinus cancer 10028767 PT
Nasal cavity cancer 10028729 PT
Myxoid liposarcoma 10073137 PT
Myxofibrosarcoma 10066948 PT
Myelofibrosis 10028537 PT
Myeloblastoma 10051141 PT
Musculoskeletal cancer 10077675 PT
Multiple endocrine neoplasia Type 2 10073149 PT
Mueller's mixed tumour 10066057 PT
Mucoepidermoid carcinoma of salivary 
gland 10073371 PT
Mucoepidermoid carcinoma 10057269 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219764
Mucinous endometrial carcinoma 10028076 PT
Colon cancer stage 0 10063523 PT
Colon cancer recurrent 10009952 PT
Colon cancer 10009944 PT
CNS germinoma 10065852 PT
Clear cell sarcoma of the kidney 10009253 PT
Clear cell sarcoma of soft tissue 10073140 PT
Clear cell renal cell carcinoma 10073251 PT
Clear cell endometrial carcinoma 10009252 PT
Papillary serous endo metrial carcinoma 10033700 PT
Papillary renal cell carcinoma 10078493 PT
Pancreatoblastoma 10073367 PT
Pancreatic sarcoma 10055006 PT
Pancreatic carcinoma stage IV 10059326 PT
Pancreatic carcinoma stage III 10059323 PT
Pancreatic carcinoma stage II 10059322 PT
Pancreatic carcinoma stage I 10059321 PT
Pancreatic carcinoma stage 0 10059320 PT
Pancreatic carcinoma recurrent 10033613 PT
Pancreatic carcinoma 10033609 PT
Pancoast's tumour 10033572 PT
Paget's disease of the vulva 10033369 PT
Paget's disease of penis 10033365 PT
Paget's disease of nipple 10033364 PT
Ovarian stromal cancer 10065858 PT
Ovarian low malignan t potential tumour 10033268 PT
Ovarian germ cell tumour mixed 10073259 PT
Ovarian germ cell teratoma stage IV 10033249 PT
Ovarian germ cell teratoma stage III 10033245 PT
Ovarian germ cell teratoma stage II 10033241 PT
Ovarian germ cell teratoma stage I 10033237 PT
Ovarian germ cell teratoma 10073265 PT
Ovarian germ cell polyembryoma stage IV 10033235 PT
Ovarian germ cell po lyembryoma stage III 10033231 PT
Ovarian germ cell polyembryoma stage II 10033227 PT
Ovarian germ cell polyembryoma stage I 10033223 PT
Ovarian germ cell polyembryoma 10073264 PT
Ovarian germ cell endodermal sinus 
tumour stage IV 10033221 PT
Ovarian germ cell endodermal sinus 
tumour stage III 10033220 PT
Ovarian germ cell endodermal sinus 
tumour stage II 10033219 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219765
Ovarian germ cell endodermal sinus 
tumour stage I 10033218 PT
Ovarian germ cell endodermal sinus 
tumour 10073263 PT
Ovarian germ cell embryonal carcinoma 
stage IV 10033208 PT
Ovarian germ cell embryonal carcinoma 
stage III 10033204 PT
Ovarian germ cell embryonal carcinoma 
stage II 10033200 PT
Mesothelioma malignant recurrent 10027411 PT
Mesothelioma malignant 10027407 PT
Meningioma malignant 10027193 PT
Medulloblastoma recurrent 10066594 PT
Medulloblastoma 10027107 PT
Medullary thyroid cancer 10027105 PT
Medullary carcinoma of breast 10027095 PT
Malignant urinary tract neoplasm 10061272 PT
Malignant transformation 10064912 PT
Malignant splenic neoplasm 10026702 PT
Testicular yolk sac tumour stage I 10043357 PT
Testicular yolk sac tumour 10073121 PT
Testicular seminoma (pure) stage III 10043352 PT
Testicular seminoma (pure) stage II 10043351 PT
Testicular seminoma (pure) stage I 10043350 PT
Testicular seminoma (pure) 10062124 PT
Testicular malignant teratoma stage III 10043341 PT
Testicular malignant teratoma stage II 10043340 PT
Testicular malignant teratoma stage I 10043339 PT
Testicular malignant teratoma 10073120 PT
Glioblastoma 10018336 PT
Gingival cancer 10067807 PT
Germ cell cancer 10061184 PT
Genitourinary melanoma 10077166 PT
Genital neoplasm malignant female 10018160 PT
Genital cancer male in situ 10073124 PT
Genital cancer male 10073116 PT
Gastrooesophageal cancer 10062878 PT
Gastrointestinal stromal tumour 10051066 PT
Gastrointestinal melanoma 10077167 PT
Gastrointestinal carcinoma in situ 10061168 PT
Gastrointestinal carcinoma 10017940 PT
Gastrinoma malignant 10051709 PT
Gastric sarcoma 10055008 PT
Iris melanoma 10073086 PT
Invasive papillary breast carcinoma 10073098 PT
Invasive lobular breast carcinoma 10073096 PT
Invasive ductal breast carcinoma 10073095 PT
Invasive breast carcinoma 10075713 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219766
Intraosseous angioma 10048846 PT
Extragonadal primary seminoma (pure) 
stage I 10015811 PT
Extragonadal primary seminoma (pure) 10073057 PT
Extragonadal primary  non-seminoma stage 
IV 10015810 PT
Extragonadal primary  non-seminoma stage 
III 10015809 PT
Extragonadal primary  non-seminoma stage 
II 10015806 PT
Extragonadal primary  non-seminoma stage 
I 10015805 PT
Extragonadal primary non-seminoma 10061849 PT
Testicular leiomyosarcoma 10057340 PT
Testicular germ cell tumour mixed stage III 10043333 PT
Testicular germ cell tumour mixed stage II 10043332 PT
Testicular germ cell tumour mixed stage I 10043331 PT
Testicular germ cell tumour mixed 10073119 PT
Testicular germ cell cancer 10061378 PT
Testicular embryonal carcinoma stage III 10043311 PT
Testicular embryonal carcinoma stage II 10043310 PT
Testicular embryonal carcinoma stage I 10043309 PT
Testicular embryonal carcinoma 10062123 PT
Testicular choriocarcinoma stage III 10043305 PT
Testicular choriocarcinoma stage II 10043304 PT
Testicular choriocarcinoma stage I 10043303 PT
Testicular choriocarcinoma recurrent 10069812 PT
Testicular choriocarcinoma 10062122 PT
Synovial sarcoma recurrent 10042867 PT
Synovial sarcoma 10042863 PT
Stewart-Treves syndrome 10059498 PT
Squamous endometrial carcinoma 10041883 PT
Squamous cell carcinoma of the vulva 10041875 PT
Squamous cell carcinoma of the vagina 10041866 PT
Squamous cell carcinoma of the tongue 10041865 PT
Squamous cell carcinoma of the oral cavity 10041857 PT
Squamous cell carcinoma of the 
hypopharynx 10041849 PT
Squamous cell carcinoma of the cervix 10041848 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219767
Squamous cell carcinoma of pharynx 10066471 PT
Squamous cell carcinoma of lung 10041826 PT
Squamous cell carcinoma of head and neck 10060121 PT
Spindle cell sarcoma 10049067 PT
Spinal meningioma malignant 10041580 PT
Spermatocytic seminoma 10073118 PT
Somatostatinoma 10041329 PT
Solid pseudopapillary tumour of the 
pancreas 10069345 PT
Soft tissue sarcoma 10075333 PT
Small intestine leiomyosarcoma 10041127 PT
Small intestine carcinoma stage IV 10059372 PT
Small intestine carcinoma stage III 10059371 PT
Small intestine carcinoma stage II 10059370 PT
Small intestine carcinoma stage I 10059369 PT
Small intestine carcinoma stage 0 10059368 PT
Small intestine carcinoma recurrent 10041124 PT
Small intestine carcinoma 10054184 PT
Small intestine adenocarcinoma 10073373 PT
Small cell lung cancer recurrent 10041070 PT
Small cell lung cancer limited stage 10041069 PT
Small cell lung cancer extensive stage 10041068 PT
Small cell lung cancer 10041067 PT
Gastric cancer stage IV 10061967 PT
Gastric cancer stage III 10017765 PT
Ovarian dysgerminoma stage unspecified 10052759 PT
Ovarian dysgerminoma stage IV 10033156 PT
Ovarian dysgerminoma stage III 10033152 PT
Ovarian dysgerminoma stage II 10033148 PT
Ovarian dysgerminoma stage I 10033144 PT
Ovarian clear cell carcinoma 10073268 PT
Ovarian cancer stage IV 10070908 PT
Ovarian cancer stage III 10070907 PT
Ovarian cancer stage II 10070906 PT
Ovarian cancer stage I 10070905 PT
Ovarian cancer recurrent 10066697 PT
Ovarian cancer 10033128 PT
Osteosarcoma recurrent 10031296 PT
Osteosarcoma 10031291 PT
Oropharyngeal squamous cell carcinoma 10031112 PT
Oropharyngeal lymphoepithelioma 10031104 PT
Oropharyngeal cancer stage IV 10064099 PT
Oropharyngeal cancer stage III 10031102 PT
Oropharyngeal cancer stage II 10031101 PT
Oropharyngeal cancer stage I 10031100 PT
Oropharyngeal cancer stage 0 10031099 PT
Oropharyngeal cancer recurrent 10031098 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219768
Oropharyngeal cancer 10031096 PT
Optic glioma 10073338 PT
Oligodendroglioma 10030286 PT
Oligoastrocytoma 10073131 PT
Hormone receptor positive breast cancer 10083234 PT
Oesophageal squamous cell carcinoma 
stage IV 10030192 PT
Oesophageal squamous cell carcinoma 
stage III 10030191 PT
Oesophageal squamous cell carcinoma 
stage II 10030190 PT
Oesophageal squamous cell carcinoma 
stage I 10030189 PT
Oesophageal squamous cell carcinoma 
stage 0 10030188 PT
Oesophageal squamous cell carcinoma 
recurrent 10030187 PT
Oesophageal squamous cell carcinoma 10061534 PT
Oesophageal carcinoma stage 0 10030162 PT
Oesophageal carcinoma recurrent 10030159 PT
Oesophageal carcinoma 10030155 PT
Oesophageal adenoca rcinoma stage IV 10030145 PT
Oesophageal adenoca rcinoma stage III 10030144 PT
Oesophageal adenoca rcinoma stage II 10030143 PT
Oesophageal adenoca rcinoma stage I 10030142 PT
Oesophageal adenoca rcinoma stage 0 10030141 PT
Oesophageal adenocarcinoma recurrent 10030140 PT
Oesophageal adenocarcinoma 10030137 PT
Ocular haemangiopericytoma 10057416 PT
NUT midline carcinoma 10078295 PT
Non-small cell lung cancer stage IV 10029522 PT
Non-small cell lung cancer stage IIIB 10029521 PT
Non-small cell lung cancer stage IIIA 10029520 PT
Non-small cell lung cancer stage III 10029519 PT
Non-small cell lung cancer stage II 10029518 PT
Non-small cell lung cancer stage I 10029517 PT
Non-small cell lung cancer stage 0 10029516 PT
Non-small cell lung cancer recurrent 10029515 PT
Non-small cell lung cancer 10061873 PT
Non-secretory adenoma of pituitary 10029556 PT
Non-renal cell carcinoma of kidney 10061872 PT
Nonkeratinising carcinoma of nasopharynx 10073325 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219769
Nongerminomatous germ  cell tumour of 
the CNS 10065871 PT
Neurofibrosarcoma recurrent 10029277 PT
Malignant giant cell fibrous histiocytoma 10073141 PT
Malignant genitourinary tract neoplasm 10074419 PT
Malignant fibrous his tiocytoma recurrent 10025561 PT
Malignant fibrous histiocytoma of bone 10025557 PT
Malignant fibrous histiocytoma 10025552 PT
Malignant cranial nerve neoplasm 10061238 PT
Malignant connective tissue neoplasm 10074340 PT
Malignant anorectal neoplasm 10061237 PT
Lymphangiosarcoma 10025223 PT
Lung squamous cell carcinoma stage IV 10025125 PT
Lung squamous cell ca rcinoma stage III 10025124 PT
Lung squamous cell carcinoma stage II 10025123 PT
Lung squamous cell carcinoma stage I 10025122 PT
Lung squamous cell carcinoma stage 0 10025121 PT
Lung squamous cell carcinoma recurrent 10025120 PT
Lung neoplasm malignant 10058467 PT
Lung infiltration malignant 10062041 PT
Lung carcinoma cell type unspecified stage 
IV 10025070 PT
Lung carcinoma cell type unspecified stage 
III 10025069 PT
Lung carcinoma cell type unspecified stage 
II 10025068 PT
Lung carcinoma cell type unspecified stage 
I 10025067 PT
Lung carcinoma cell type unspecified stage 
0 10025066 PT
Lung carcinoma cell type unspecified 
recurrent 10025065 PT
Lung adenocarcinoma stage IV 10025038 PT
Lung adenocarcinoma stage III 10025037 PT
Lung adenocarcinoma stage II 10025036 PT
Lung adenocarcinoma stage I 10025035 PT
Lung adenocarcinoma stage 0 10025034 PT
Lung adenocarcinoma recurrent 10025033 PT
Lung adenocarcinoma 10025031 PT
Lobular breast carcinoma in situ 10073099 PT
Liver carcinoma ruptured 10050842 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219770
Liposarcoma recurrent 10024632 PT
Liposarcoma 10024627 PT
Lip squamous cell carcinoma 10064055 PT
Sarcomatoid mesothelioma 10073065 PT
Sarcoma uterus 10039497 PT
Sarcoma of skin 10039495 PT
Sarcoma 10039491 PT
Salivary gland cancer stage IV 10039403 PT
Salivary gland cancer stage III 10039402 PT
Salivary gland cancer stage II 10039401 PT
Salivary gland cancer stage I 10039400 PT
Salivary gland cancer stage 0 10039399 PT
Salivary gland cancer recurrent 10039398 PT
Salivary gland cancer 10061934 PT
Round cell liposarcoma 10073139 PT
Rhabdomyosarcoma recurrent 10039027 PT
Rhabdomyosarcoma 10039022 PT
Rhabdoid tumour of the kidney 10039019 PT
Rhabdoid tumour 10073334 PT
Retroperitoneal cancer 10038977 PT
Retinoblastoma 10038916 PT
Retinal melanoma 10038878 PT
Respiratory tract carcinoma in situ 10038724 PT
Renal cell carcinoma stage IV 10038414 PT
Renal cell carcinoma stage III 10038413 PT
Renal cell carcinoma stage II 10038412 PT
Renal cell carcinoma stage I 10038411 PT
Renal cell carcinoma recurrent 10038410 PT
Renal cell carcinoma 10067946 PT
Renal cancer stage IV 10038394 PT
Renal cancer stage III 10038393 PT
Renal cancer stage II 10038392 PT
Renal cancer stage I 10038391 PT
Inflammatory carcinoma of the breast 10021980 PT
Inflammatory carcinoma of breast stage IV 10021979 PT
Inflammatory carcinoma of breast stage III 10021978 PT
Extragonadal primary malignant teratoma 10061848 PT
Extragonadal primary embryonal 
carcinoma 10015789 PT
Ewing's sarcoma recurrent 10015564 PT
Ewing's sarcoma 10015560 PT
Erythroplasia of vulva 10052825 PT
Rectosigmoid cancer stage 0 10038095 PT
Rectosigmoid cancer recurrent 10038094 PT
Rectosigmoid cancer 10038086 PT
Rectal cancer stage IV 10038051 PT
Rectal cancer stage III 10038050 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219771
Rectal cancer stage II 10038049 PT
Rectal cancer stage I 10038048 PT
Rectal cancer stage 0 10038047 PT
Rectal cancer recurrent 10038046 PT
Rectal cancer 10038038 PT
Rectal adenocarcinoma 10038019 PT
Prostate cancer stage IV 10036920 PT
Prostate cancer stage III 10036919 PT
Prostate cancer stage II 10036918 PT
Prostate cancer stage I 10036917 PT
Prostate cancer stage 0 10036912 PT
Prostate cancer recurrent 10036911 PT
Prostate cancer 10060862 PT
Primitive neuroectodermal tumour 10057846 PT
Mucinous cystadenocarcinoma ovary 10054914 PT
Mucinous breast carcinoma 10073101 PT
Mucinous adenocarcinoma of appendix 10073361 PT
Mixed-type liposarcoma 10073136 PT
Mixed hepatocellular cholangiocarcinoma 10027761 PT
Mixed adenoneuroendocrine carcinoma 10076748 PT
Metaplastic breast carcinoma 10073100 PT
Laryngeal squamous cell carcinoma 10023856 PT
Laryngeal cancer stage IV 10023833 PT
Laryngeal cancer stage III 10023832 PT
Laryngeal cancer stage II 10023831 PT
Laryngeal cancer stage I 10023830 PT
Laryngeal cancer stage 0 10023829 PT
Laryngeal cancer recurrent 10023828 PT
Laryngeal cancer 10023825 PT
Large cell lung cancer stage IV 10023780 PT
Large cell lung cancer stage III 10023779 PT
Large cell lung cancer stage II 10023778 PT
Large cell lung cancer stage I 10023777 PT
Large cell lung cancer stage 0 10023776 PT
Large cell lung cancer recurrent 10023775 PT
Large cell lung cancer 10023774 PT
Langerhans' cell histiocytosis 10069698 PT
Keratinising squamous cell carcinoma of 
nasopharynx 10073324 PT
Kaposi's sarcoma classical type 10023288 PT
Kaposi's sarcoma 10023284 PT
Adenosquamous cell lung cancer stage 0 10001248 PT
Adenosquamous cell lung cancer recurrent 10001247 PT
Adenosquamous cell lung cancer 10001245 PT
Adenosquamous cell carcinoma 10068873 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219772
Adenosquamous carcinoma of vagina 10073978 PT
Adenosquamous carcinoma of the cervix 10001244 PT
Adenoid cystic carcinoma of salivary gland 10073370 PT
External ear neoplasm malignant 10082277 PT
Adenoid cystic carcinoma 10053231 PT
Adenocarcinoma pancreas 10052747 PT
Adenocarcinoma of the cervix 10001197 PT
Adenocarcinoma of salivary gland 10068068 PT
Adenocarcinoma of colon 10001167 PT
Adenocarcinoma of appendix 10073359 PT
Adenocarcinoma gastric 10001150 PT
Adenocarcinoma 10001141 PT
Acinic cell carcinoma of salivary gland 10073369 PT
Acinar cell carcinoma of pancreas 10073363 PT
Abdominal wall neoplasm malignant 10071023 PT
Yolk sac tumour site unspecified 10048251 PT
Vulvar adenocarcinoma 10063536 PT
Vulval cancer stage IV 10047749 PT
Vulval cancer stage III 10047748 PT
Vulval cancer stage II 10047747 PT
Vulval cancer stage I 10047746 PT
Vulval cancer stage 0 10047745 PT
Vulval cancer recurrent 10047744 PT
Vulval cancer 10047741 PT
Vaginal cancer stage IVB 10046895 PT
Vaginal cancer stage IVA 10046894 PT
Vaginal cancer stage III 10046893 PT
Vaginal cancer stage II 10046892 PT
Vaginal cancer stage I 10046891 PT
Vaginal cancer stage 0 10046890 PT
Vaginal cancer recurrent 10046889 PT
Vaginal cancer 10046885 PT
Vaginal adenocarcinoma 10065349 PT
Uterine carcinoma in situ 10046770 PT
Uterine cancer 10046766 PT
Urinary tract carcinoma in situ 10061396 PT
Urinary bladder sarcoma 10051690 PT
Urethral cancer recurrent 10046435 PT
Urethral cancer 10046431 PT
Ureteric cancer regional 10046397 PT
Ureteric cancer recurrent 10046396 PT
Ureteric cancer local 10046393 PT
Malignant respiratory tract neoplasm 10061270 PT
Malignant polyp 10078695 PT
Malignant pituitary tumour 10026672 PT
Malignant peritoneal neoplasm 10061269 PT
Malignant pericardial neoplasm 10054946 PT
Malignant palate neoplasm 10026663 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219773
Malignant ovarian cyst 10026662 PT
Malignant olig odendroglioma 10026659 PT
Malignant nipple neoplasm male 10053128 PT
Malignant nipple neoplasm female 10053129 PT
Malignant nipple neoplasm 10062051 PT
Malignant nervous system neoplasm 10061268 PT
Malignant neoplasm progression 10051398 PT
Malignant neoplasm papilla of Vater 10077303 PT
Malignant neoplasm of uterine adnexa 10026616 PT
Malignant neoplasm of unknown primary 
site 10073059 PT
Malignant neoplasm of thymus 10026533 PT
Malignant neoplasm of thorax 10026532 PT
Malignant neoplasm of spinal cord 10026472 PT
Malignant neoplasm of spermatic cord 10026470 PT
Malignant neoplasm of seminal vesicle 10068124 PT
Malignant neoplasm of retina 10026432 PT
Lip neoplasm malignant stage unspecified 10024557 PT
Lip and/or oral cavity cancer stage IV 10024540 PT
Lip and/or oral cavity cancer stage III 10024539 PT
Lip and/or oral cavity cancer stage II 10024538 PT
Lip and/or oral cavity cancer stage I 10024537 PT
Lip and/or oral cavity cancer stage 0 10024536 PT
Lip and/or oral cavity cancer recurrent 10024535 PT
Malignant neoplasm of renal pelvis 10026426 PT
Malignant neoplasm of pleura 10026351 PT
Malignant neoplasm of placenta 10026350 PT
Malignant neoplasm of paraurethral 
glands 10026326 PT
Malignant neoplasm of orbit 10026183 PT
Malignant neoplasm of lacrimal gland 10026031 PT
Malignant neoplasm of lacrimal duct 10026030 PT
Malignant neoplasm of islets of 
Langerhans 10025997 PT
Malignant neoplasm of eyelid 10063693 PT
Malignant neoplasm of eye 10025910 PT
Malignant neoplasm of cornea 10025871 PT
Malignant neoplasm of conjunctiva 10025861 PT
Malignant neoplasm of choroid 10025839 PT
Malignant neoplasm of ampulla of Vater 10025697 PT
Malignant muscle neoplasm 10062050 PT
Malignant middle ear neoplasm 10061267 PT
Malignant mesenteric neoplasm 10067369 PT
Malignant mesenchymoma recurrent 10025677 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219774
Malignant mesenchymoma 10061526 PT
Malignant melanoma of sites other than 
skin 10025654 PT
Malignant melanoma of eyelid 10063706 PT
Malignant melanoma 10025650 PT
Malignant mediastinal neoplasm 10061241 PT
Malignant mast cell neoplasm 10025638 PT
Malignant joint neoplasm 10078145 PT
Malignant hydatidiform mole 10025598 PT
Malignant histiocytosis 10025581 PT
Malignant haemangiopericytoma 
recurrent 10025570 PT
Malignant haemangiopericytoma 10025566 PT
Malignant glioma 10065443 PT
Penis carcinoma stage I 10034332 PT
Penis carcinoma recurrent 10034331 PT
Penile squamous cell carcinoma 10059631 PT
Penile cancer 10034299 PT
Parathyroid tumour malignant 10033965 PT
Paranasal sinus and nasal cavity malignant 
neoplasm stage IV 10033860 PT
Paranasal sinus and nasal cavity malignant 
neoplasm stage III 10033859 PT
Paranasal sinus and nasal cavity malignant 
neoplasm stage II 10033858 PT
Paranasal sinus and nasal cavity malignant 
neoplasm stage I 10033857 PT
Paranasal sinus and nasal cavity malignant 
neoplasm stage 0 10033856 PT
Paranasal sinus and nasal cavity malignant 
neoplasm recurrent 10033855 PT
Paranasal sinus and nasal cavity malignant 
neoplasm 10061909 PT
Paraganglion neoplasm malignant 10033791 PT
Papillary thyroid cancer 10033701 PT
Ureteric cancer 10046392 PT
Undifferentiated sarcoma 10045515 PT
Undifferentiated nasopharyngeal 
carcinoma 10073328 PT
Undifferentiated carcinoma of colon 10073362 PT
Tumour of ampulla of Vater 10073851 PT
Tumour invasion 10064390 PT
Tumour budding 10076969 PT
Tubular breast carcinoma 10073104 PT
Triple negative breast cancer 10075566 PT
Transitional cell carcinoma urethra 10044426 PT
Transitional cell carcinoma recurrent 10077051 PT
Ovarian germ cell cancer 10061893 PT
Ovarian epithelial cancer stage IV 10033164 PT
Ovarian epithelial cancer stage III 10033163 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219775
Ovarian epithelial cancer stage II 10033162 PT
Ovarian epithelial cancer stage I 10033161 PT
Ovarian epithelial cancer recurrent 10033160 PT
Ovarian epithelial cancer 10061328 PT
Ovarian endometrioid carcinoma 10073269 PT
Ovarian embryonal carcinoma 10056266 PT
Bile duct cancer stage 0 10059384 PT
Bile duct cancer recurrent 10004596 PT
Bile duct cancer 10004593 PT
Bile duct adenosquamous carcinoma 10004589 PT
Bile duct adenocarcinoma 10004585 PT
Basosquamous carcinoma 10004178 PT
Atypical teratoid/rhabdoid tumour of CNS 10065907 PT
Astrocytoma malignant 10060971 PT
Astrocytoma 10003571 PT
APUDoma 10003069 PT
Appendix cancer 10073360 PT
Apocrine breast carcinoma 10066206 PT
Angiosarcoma recurrent 10002480 PT
Angiosarcoma non-metastatic 10057700 PT
Angiosarcoma 10002476 PT
Angiocentric glioma 10073129 PT
Anaplastic thyroid cancer 10002240 PT
Anaplastic oligodendroglioma 10073128 PT
Anaplastic meningioma 10073127 PT
Anaplastic astrocytoma 10002224 PT
Anal squamous cell carcinoma 10073358 PT
Anal cancer stage IV 10002138 PT
Bladder adenocarcinoma stage II 10004989 PT
Bladder adenocarcinoma stage I 10004988 PT
Bladder adenocarcinoma stage 0 10004987 PT
Bladder adenocarcinoma recurrent 10004986 PT
Biphasic mesothelioma 10073062 PT
Bile duct squamous cell carcinoma 10004633 PT
Bile duct cancer stage IV 10059376 PT
Bile duct cancer stage III 10059375 PT
Bile duct cancer stage II 10059374 PT
Bile duct cancer stage I 10059373 PT
Postcricoid cancer 10036334 PT
Poorly differentiated thyroid carcinoma 10076603 PT
Polycythaemia vera 10036057 PT
Pleural sarcoma 10051950 PT
Pleural mesothelioma malignant recurrent 10035607 PT
Pleural mesothelioma malignant 10059518 PT
Pleural mesothelioma 10035603 PT
Pleomorphic malignant fibrous 
histiocytoma 10073143 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219776
Pleomorphic liposarcoma 10073138 PT
Plasmacytoma 10035484 PT
Plasma cell myeloma recurrent 10073133 PT
Plasma cell myeloma in remission 10073132 PT
Plasma cell myeloma 10035226 PT
Pituitary neoplasm malignant recurrent 10057838 PT
Pinealoblastoma 10050487 PT
Anal cancer stage III 10002137 PT
Anal cancer stage II 10002136 PT
Anal cancer stage I 10002135 PT
Anal cancer stage 0 10002134 PT
Anal cancer recurrent 10002133 PT
Anal cancer 10061424 PT
Alveolar soft part sarcoma recurrent 10001887 PT
Alveolar soft part sarcoma 10001882 PT
Alveolar rhabdomyosarcoma 10065867 PT
Aesthesioneuroblastoma 10001433 PT
Adrenocortical carcinoma 10001388 PT
Adrenal gland cancer 10073152 PT
Adenosquamous cell lung cancer stage IV 10001254 PT
Adenosquamous cell lung cancer stage III 10001251 PT
Adenosquamous cell lung cancer stage II 10001250 PT
Adenosquamous cell lung cancer stage I 10001249 PT
Breast cancer female 10057654 PT
Breast cancer 10006187 PT
Breast angiosarcoma 10072813 PT
Brain teratoma 10068394 PT
Brain stem glioma 10006143 PT
Brain sarcoma 10073857 PT
Brain neoplasm malignant 10006131 PT
Borderline serous tumour of ovary 10073267 PT
Borderline ovarian tumour 10006032 PT
Borderline mucinous tumour of ovary 10073266 PT
Bone sarcoma 10006007 PT
Bone marrow tumour cell infiltration 10049556 PT
Bone giant cell tumour malignant 10073106 PT
Bone cancer 10005949 PT
Bladder transitional c ell carcinoma stage IV 10066752 PT
Bladder transitional ce ll carcinoma stage III 10066754 PT
Bladder transitional c ell carcinoma stage II 10066753 PT
Bladder transitional c ell carcinoma stage I 10066751 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219777
Bladder transitional c ell carcinoma stage 0 10066749 PT
Bladder transitional cell carcinoma 
recurrent 10066750 PT
Bladder transitional cell carcinoma 10005084 PT
Bladder squamous ce ll carcinoma stage 
unspecified 10005081 PT
Bladder squamous ce ll carcinoma stage IV 10005080 PT
Bladder squamous cell carcinoma stage III 10005079 PT
Bladder squamous ce ll carcinoma stage II 10005078 PT
Bladder squamous ce ll carcinoma stage I 10005077 PT
Bladder squamous ce ll carcinoma stage 0 10005076 PT
Bladder squamous cell carcinoma 
recurrent 10005075 PT
Bladder cancer stage IV 10005012 PT
Bladder cancer stage III 10005011 PT
Bladder cancer stage II 10005010 PT
Bladder cancer stage I, without cancer in 
situ 10005009 PT
Bladder cancer stage I, with cancer in situ 10005008 PT
Bladder cancer stage 0, without cancer in 
situ 10005007 PT
Bladder cancer stage 0, with cancer in situ 10005006 PT
Bladder cancer recurrent 10005005 PT
Bladder cancer 10005003 PT
Bladder adenocarcinoma stage unspecified 10004992 PT
Bladder adenocarcinoma stage IV 10004991 PT
Bladder adenocarcinoma stage III 10004990 PT
Pineal parenchymal neoplasm malignant 10061537 PT
Pineal germinoma 10035052 PT
Pharyngeal cancer stage IV 10034818 PT
Pharyngeal cancer stage III 10034817 PT
Pharyngeal cancer stage II 10034816 PT
Pharyngeal cancer stage I 10034815 PT
Pharyngeal cancer stage 0 10034814 PT
Pharyngeal cancer recurrent 10034813 PT
Pharyngeal cancer 10034811 PT
Phaeochromocytoma malignant 10051710 PT
Phaeochromocytoma crisis 10068778 PT
Phaeochromocytoma 10034800 PT
Peritoneal sarcoma 10051949 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219778
Peritoneal mesothelioma malignant 
recurrent 10034671 PT
Peritoneal mesothelioma malignant 10056558 PT
Peritoneal gliomatosis 10070561 PT
Peripheral primitive neuroectodermal 
tumour of soft tissue 10073144 PT
Peripheral primitive neuroectodermal 
bone tumour 10073107 PT
Peripheral neuroepithelioma of soft tissue 10057646 PT
Peripheral neuroepithelioma of bone 
recurrent 10034605 PT
Peripheral neuroepithelioma of bone 10061342 PT
Neurofibrosarcoma 10061527 PT
Pericardial mesothelioma malignant 
recurrent 10034480 PT
Pericardial mesothelioma malignant 10073066 PT
Penis carcinoma stage IV 10034335 PT
Penis carcinoma stage III 10034334 PT
Penis carcinoma stage II 10034333 PT
090177e198d54486\Final\Final On: 10-Dec-2021 02:59 (GMT)
FDA-CBER-2022-5812-0219779