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Upcoming Cancer & Oncology FDA decisions & readouts

PDUFA target dates and trial readouts in cancer disease, each linked to its primary source. Updated from FDA/SEC/ClinicalTrials.gov; dates can shift.

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PDUFA decisions (13)

ARVN · 2026-06-05

ARV-471 — Advanced Breast Cancer

ACHV · 2026-06-20

Custirsen — Non-Small Cell Lung Cancer

ALPMY · 2026-08-17

Pembrolizumab combination — Oncology (Priority Review)

HOOK · 2026-08-17

Pembrolizumab combination — Oncology (Priority Review)

CRBP · 2026-08-17

Pembrolizumab combination — Oncology (Priority Review)

NCNA · 2026-08-17

Pembrolizumab combination — Oncology (Priority Review)

TLX · 2026-09-11

177Lu-TLX591 — Metastatic Castration-resistant Prostate Cancer

NUVL · 2026-09-18

Neladalkib — Non-small Cell Lung Cancer

BAYRY · 2026-11-30

Sevabertinib (BAY 2927088) — HER2-mutant NSCLC

RHHBY · 2026-12-18

Giredestrant — ER+/HER2- metastatic breast cancer

COGT · 2026-12-30

CGT9486 — Advanced Gastrointestinal Stromal Tumors

CGEM · 2027-02-27

CLN-081 — Non Small Cell Lung Cancer

INBX · 2027-04-14

INBRX-106 — Head and Neck Squamous Cell Carcinoma (HNSCC)

Trial readouts (264)

LEGN · Jun 2026 (est.)

LCAR-B38M CAR-T Cell — B-Cell Non-Hodgkin Lymphoma-Recurrent

JAZZ · Jun 2026 (est.)

Zanidatamab — Gastroesophageal Adenocarcinoma

CLLS · Jun 2026 (est.)

UCART22 — B-cell Acute Lymphoblastic Leukemia

CELC · Jun 2026 (est.)

Gedatolisib — Breast Cancer

BMY · Jun 2026 (est.)

Nivolumab — Metastatic Renal Cell Carcinoma

OLMA · Jun 2026 (est.)

Palazestrant — Breast Cancer

TLX · Jun 2026 (est.)

177Lu-TLX591 — Clear Cell Renal Cell Carcinoma

JAZZ · Jul 2026 (est.)

Lurbinectedin — Advanced Soft-tissue Sarcoma

IOVA · Jul 2026 (est.)

Lifileucel plus Pembrolizumab — Soft Tissue Sarcoma

HOWL · Jul 2026 (est.)

WTX-330 — Metastatic Solid Tumor

EXEL · Jul 2026 (est.)

Cabozantinib — Non-Small Cell Lung Cancer

ELVN · Jul 2026 (est.)

ELVN-002 — HER2 Mutant Non-small Cell Lung Cancer

CRDF · Jul 2026 (est.)

Onvansertib — Pancreatic Cancer

SMMT · Jul 2026 (est.)

Ivonescimab — Salivary Gland Cancer

PYXS · Jul 2026 (est.)

PYX-201 — Solid Tumor

CANF · Jul 2026 (est.)

Namodenoson — Pancreatic Adenocarcinoma

LTRN · Jul 2026 (est.)

Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel — Advanced Solid Tumor

JAZZ · Jul 2026 (est.)

Tislelizumab — Gastric Neoplasms

PSNL · Jul 2026 (est.)

Pembrolizumab — Adenocarcinoma of the Colon

KPTI · Aug 2026 (est.)

Selinexor — Endometrial Cancer

CADL · Aug 2026 (est.)

Aglatimagene Besadenovec — Prostate Cancer Patients Treated by Radiotherapy

CORT · Aug 2026 (est.)

Relacorilant — Ovarian Cancer

CRIS · Aug 2026 (est.)

chondrocyte-alginate gel suspension — Relapsed Hematologic Malignancy

NCNA · Aug 2026 (est.)

NUC-1031 — Advanced Cancer

ACRV · Aug 2026 (est.)

ACR-368 — Specific Advanced Solid Tumors

PMVP · Aug 2026 (est.)

rezatapopt — Advanced Solid Tumor

CLRB · Aug 2026 (est.)

NOV-002 — Pediatric Solid Tumor

NRIX · Aug 2026 (est.)

NX-5948 — Ovarian Cancer, Epithelial

ARVN · Sep 2026 (est.)

ARV-471 — Breast Cancer

GILD · Sep 2026 (est.)

Sacituzumab Govitecan — Non-small Cell Lung Cancer

CGEM · Sep 2026 (est.)

CLN-081 — Multiple Myeloma

LEGN · Sep 2026 (est.)

LCAR-B38M CAR-T Cell — Relapsed B-cell Non-Hodgkin Lymphoma

IOVA · Sep 2026 (est.)

Lifileucel plus Pembrolizumab — Gastric Cancer

TYRA · Sep 2026 (est.)

TYRA-300 — Locally Advanced Cholangiocarcinoma

PCSA · Sep 2026 (est.)

PCS6422 and capecitabine — Breast Cancer

MRK · Sep 2026 (est.)

Pembrolizumab — Metastatic Triple-Negative Breast Cancer

NVCR · Sep 2026 (est.)

Temozolomide — Anaplastic (Malignant) Meningioma

ORIC · Sep 2026 (est.)

ORIC-114 — Solid Tumors

BMY · Sep 2026 (est.)

Bevacizumab — Advanced Solid Tumors

IBRX · Sep 2026 (est.)

ALT-803 — Non-muscle Invasive Bladder Cancer

EXEL · Sep 2026 (est.)

Cabozantinib — High Grade Neuroendocrine Neoplasms

CHRS · Sep 2026 (est.)

CHS-1420 — Advanced Solid Tumor

CCCC · Sep 2026 (est.)

Cemsidomide — Multiple Myeloma

IMMP · Sep 2026 (est.)

eftilagimod alfa — Solid Tumors

PFE · Oct 2026 (est.)

Palbociclib — Metastatic Renal Cell Carcinoma

SNDX · Oct 2026 (est.)

Revumenib — Refractory Acute Myeloid Leukemia

AGEN · Oct 2026 (est.)

Balstilimab — Anatomic Stage IV Breast Cancer AJCC v8

IOVA · Oct 2026 (est.)

Lifileucel plus Pembrolizumab — HPV-Associated Cervical Carcinoma

PSTV · Oct 2026 (est.)

Rhenium Liposome Treatment — Leptomeningeal Metastasis

ADCT · Oct 2026 (est.)

Loncastuximab Tesirine — B-Cell Non-Hodgkin Lymphoma

MRK · Oct 2026 (est.)

Pembrolizumab — Metastatic Uveal Melanoma

INBX · Oct 2026 (est.)

INBRX-106 — Solid Tumor

RCUS · Oct 2026 (est.)

Zimberelimab — Non Small Cell Lung Cancer

ADAG · Oct 2026 (est.)

Pembrolizumab — Advanced/Metastatic Solid Tumors

IMMP · Oct 2026 (est.)

eftilagimod alfa — Breast Carcinoma

ATOS · Nov 2026 (est.)

Z-Endoxifen — Breast Neoplasms

TLX · Nov 2026 (est.)

177Lu-TLX591 — Prostate Adenocarcinoma

ERAS · Nov 2026 (est.)

Naporafenib — Advanced or Metastatic Solid Tumors

GILD · Nov 2026 (est.)

Sacituzumab Govitecan — Esophageal Squamous Cell Carcinoma

IOVA · Nov 2026 (est.)

Lifileucel plus Pembrolizumab — Metastatic Melanoma

ONC · Nov 2026 (est.)

BGB-11417 — Relapsed/Refractory Multiple Myeloma

ANL · Nov 2026 (est.)

Buparlisib & Paclitaxel — Advanced Solid Tumor

TYRA · Nov 2026 (est.)

TYRA-300 — Locally Advanced Urothelial Carcinoma

ELTX · Nov 2026 (est.)

ELI-002 7P — Pancreatic Ductal Adenocarcinoma

CRDF · Nov 2026 (est.)

Onvansertib — Metastatic Colorectal Cancer

BYSI · Nov 2026 (est.)

Docetaxel + Plinabulin — Multiple Myeloma

PGEN · Nov 2026 (est.)

PRGN-2009 — Cervical Cancer

AURA · Nov 2026 (est.)

Bel-sar — Eye Cancer

EXEL · Dec 2026 (est.)

Cabozantinib — Metastatic Renal Cell Carcinoma

BEAM · Dec 2026 (est.)

BEAM-302 — Lymphoblastic Lymphoma

BMY · Dec 2026 (est.)

Nivolumab — Non Small Cell Lung Cancer

CMPX · Dec 2026 (est.)

CTX-009 — Biliary Tract Cancer

CNTX · Dec 2026 (est.)

Onapristone ER — Mesothelin-Expressing Tumors

DCTH · Dec 2026 (est.)

Cisplatin and Gemcitabine — Refractory Metastatic Colorectal Cancer

EIKN · Dec 2026 (est.)

EIK1001 — Solid Tumor, Adult

AGEN · Dec 2026 (est.)

Balstilimab — Refractory Metastatic Colorectal Cancer

ADCT · Dec 2026 (est.)

Loncastuximab Tesirine — Diffuse Large B-Cell Lymphoma

MNPR · Dec 2026 (est.)

Clonidine HCl Mucoadhesive Buccal Tablet — Solid Tumor, Adult

MRK · Dec 2026 (est.)

Pembrolizumab — Squamous Cell Cancer of Head and Neck

ORIC · Dec 2026 (est.)

ORIC-114 — Solid Tumors

PBYI · Dec 2026 (est.)

neratinib — Breast Cancer

PFE · Dec 2026 (est.)

Elranatamab — Multiple Myeloma

RCUS · Dec 2026 (est.)

Quemliclustat — Borderline Resectable Pancreatic Adenocarcinoma

GLSI · Dec 2026 (est.)

GLSI-100 — Breast Cancer

GNLX · Dec 2026 (est.)

olvimulogene nanivacirepvec — SCLC, Extensive Stage

JAZZ · Dec 2026 (est.)

CPX-351 — Acute Myeloid Leukemia (AML) in Remission

KPTI · Dec 2026 (est.)

Rituximab — Relapsed/Refractory Diffuse Large B-cell Lymphoma

KZIA · Dec 2026 (est.)

GDC-0084 — Primary Central Nervous System Lymphoma

LTRN · Dec 2026 (est.)

Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel — Adenocarcinoma of Lung

SMMT · Dec 2026 (est.)

Ivonescimab — Stomach Cancer Stage IV

SNDX · Dec 2026 (est.)

Revumenib — Leukemia

ZNTL · Dec 2026 (est.)

Investigator's choice of Chemotherapy — High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer

XNCR · Dec 2026 (est.)

XMAB20717 — Biliary Tract Cancer

PFE · Dec 2026 (est.)

Mevrometostat — Metastatic Castration-Resistant Prostate Cancer

CRDF · Dec 2026 (est.)

Onvansertib — Breast Cancer

SNDX · Dec 2026 (est.)

Revumenib — Acute Myeloid Leukemia

ARVN · Dec 2026 (est.)

ARV-471 — Breast Cancer

PBYI · Dec 2026 (est.)

neratinib — Lung Cancer Metastatic

PFE · Dec 2026 (est.)

Palbociclib — Breast Cancer

SYK · Dec 2026 (est.)

Ropivacaine — Sarcoma

ACTU · Dec 2026 (est.)

Losartan — Pancreatic Adenocarcinoma

ADAG · Dec 2026 (est.)

Pembrolizumab — Advanced Solid Tumor

ADCT · Dec 2026 (est.)

Loncastuximab Tesirine — Chronic Lymphocytic Leukemia

ARVN · Dec 2026 (est.)

ARV-471 — Breast Cancer

JAZZ · Dec 2026 (est.)

Zanidatamab — Breast Cancer

BCAX · Dec 2026 (est.)

Ficerafusp alfa — Head and Neck Squamous Cell Carcinoma

CLDX · Dec 2026 (est.)

Barzolvolimab — Breast Cancer

ESLA · Dec 2026 (est.)

EB103 — B-Cell Non-Hodgkin's Lymphoma (NHL)

EXEL · Dec 2026 (est.)

XL-092 — Hepatocellular Carcinoma

TVRD · 2026-H1

TTI-101 — Hepatocellular Carcinoma

CGON · 2026-H1

Cretostimogene Grenadenorepvec — Non Muscle Invasive Bladder Cancer

ZNTL · 2026-H2

Investigator's choice of Chemotherapy — Ovarian Cancer

AURA · 2026-H2

Bel-sar — Choroidal Melanoma

CGEM · Jan 2027 (est.)

CLN-081 — Relapsed/Refractory Acute Myeloid Leukemia (AML)

ELVN · Jan 2027 (est.)

ELVN-002 — HER2-positive Breast Cancer

EXEL · Jan 2027 (est.)

Cabozantinib — Germ Cell Tumor

INAB · Jan 2027 (est.)

Autologous genetically modified gamma-delta T cells — Acute Myeloid Leukemia

IOVA · Jan 2027 (est.)

Lifileucel plus Pembrolizumab — Cervical Cancer

KURA · Jan 2027 (est.)

Ziftomenib — Solid Tumors With HRAS Alterations

NRIX · Jan 2027 (est.)

NX-5948 — Chronic Lymphocytic Leukemia (CLL)

NUVL · Jan 2027 (est.)

Neladalkib — Locally Advanced Solid Tumor

CADL · Jan 2027 (est.)

Aglatimagene Besadenovec — Malignant Glioma of Brain

BMY · Jan 2027 (est.)

Nivolumab — Hodgkin Lymphoma

REGN · Jan 2027 (est.)

Odronextamab — Follicular Lymphoma

GILD · Jan 2027 (est.)

MK-3475 — Carcinoma, Non-Small-Cell Lung

IDYA · Jan 2027 (est.)

Darovasertib — Metastatic Uveal Melanoma

CRBP · Jan 2027 (est.)

CRB-701 — Solid Tumor, Adult

SGMT · Jan 2027 (est.)

Denifanstat — Prostatic Neoplasms, Castration-Resistant

IDYA · Jan 2027 (est.)

IDE196 — Metastatic Uveal Melanoma

APLM · Jan 2027 (est.)

Uproleselan — Metastatic Non Small Cell Lung Cancer

TVRD · Feb 2027 (est.)

TTI-101 — Hepatocellular Carcinoma

SNDX · Feb 2027 (est.)

Revumenib — Acute Myeloid Leukemias

MRK · Feb 2027 (est.)

Pembrolizumab — Triple Negative Breast Cancer

GNLX · Feb 2027 (est.)

olvimulogene nanivacirepvec — Advanced Non-squamous Non-small-cell Lung Cancer

KRYS · Feb 2027 (est.)

KB803 — Lung Cancer, Non-small Cell

NVCR · Feb 2027 (est.)

Temozolomide — Spinal Metastasis

AZN · Feb 2027 (est.)

R-Chop — Diffuse Large B-Cell Lymphoma

ADCT · Mar 2027 (est.)

Loncastuximab Tesirine — Relapsed or Refractory Large B-cell Lymphoma

NUVB · Mar 2027 (est.)

safusidenib — Advanced Solid Tumor

ONC · Mar 2027 (est.)

Zanubrutinib — Mantle Cell Lymphoma; Non-Hodgkin Lymphoma

URGN · Mar 2027 (est.)

UGN-104 — Upper Urinary Tract Urothelial Carcinoma

VSTM · Mar 2027 (est.)

avutometinib — Mesonephric Gynecologic Cancer

AGIO · Mar 2027 (est.)

Mitapivat — Chondrosarcoma

ALLR · Mar 2027 (est.)

2X-121 — Advanced Ovarian Cancer

AURA · Mar 2027 (est.)

Bel-sar — Non-muscle-invasive Bladder Cancer

IPHA · Mar 2027 (est.)

Monalizumab — Metastatic Cancer

BPTH · Mar 2027 (est.)

BP1001 in combination with Ventoclax plus decitabine — Acute Myeloid Leukemia, in Relapse

CGEN · Mar 2027 (est.)

COM701 — Ovarian Cancer

COGT · Mar 2027 (est.)

CGT9486 — Intrahepatic Cholangiocarcinoma (Icc)

SNDX · Mar 2027 (est.)

Revumenib — Acute Myeloid Leukemia

UTHR · Mar 2027 (est.)

CDX-1140 — Ovarian Clear Cell Adenocarcinoma

GILD · Mar 2027 (est.)

Sacituzumab Govitecan — HER2-negative Breast Cancer

CGON · Mar 2027 (est.)

Cretostimogene Grenadenorepvec — High-Risk Non-Muscle-Invasive Bladder Cancer

TNGX · Mar 2027 (est.)

Abemaciclib — Non Small Cell Lung Cancer

KPTI · Apr 2027 (est.)

Selinexor — Multiple Myeloma

LONA · Apr 2027 (est.)

Lasofoxifene in combination with abemaciclib — Metastatic Breast Cancer

PBLS · Apr 2027 (est.)

FOG-001 — Cancer

SMMT · Apr 2027 (est.)

Ivonescimab — Endometrial Cancer

VSTM · Apr 2027 (est.)

avutometinib — Low-Grade Serous Ovarian Cancer

CLDX · Apr 2027 (est.)

Barzolvolimab — Malignant Epithelial Neoplasms

IOVA · Apr 2027 (est.)

Lifileucel plus Pembrolizumab — Bone Sarcoma

IDYA · Apr 2027 (est.)

Darovasertib — Uveal Melanoma

REGN · Apr 2027 (est.)

Cemiplimab — Colon Cancer

AIM · Apr 2027 (est.)

Ampligen — Prostate Adenocarcinoma

TELO · May 2027 (est.)

Zn-Telomir — Triple-Negative Breast Cancer (TNBC)

TNGX · May 2027 (est.)

S095035 — MTAP-deleted Solid Tumors

IOVA · May 2027 (est.)

Lifileucel plus Pembrolizumab — Uveal Melanoma

BOLT · May 2027 (est.)

BDC-4182 — Gastric Cancer Adenocarcinoma Metastatic

CMPX · May 2027 (est.)

CTX-009 — Metastatic Biliary Tract Cancer

GH · May 2027 (est.)

FOLFIRI+cetuximab — Metastatic Non-small Cell Lung Cancer

REGN · May 2027 (est.)

Cemiplimab — Recurrent Ovarian Cancer

REGN · May 2027 (est.)

Cemiplimab — Non-Small Cell Lung Cancer

OLMA · May 2027 (est.)

Palazestrant — Advanced or Metastatic ER+ HER2- Breast Cancer (mBC)

ZLAB · May 2027 (est.)

ZL-1310 — SCLC

ACRV · May 2027 (est.)

ACR-368 — Endometrial Adenocarcinoma

RVMD · May 2027 (est.)

RMC-6236 — Non-small Cell Lung Cancer (NSCLC)

BLLN · Jun 2027 (est.)

5-Fluorouracil — Gastroesophageal Adenocarcinoma

BSX · Jun 2027 (est.)

Colchicine — Hepatocellular Carcinoma

EIKN · Jun 2027 (est.)

EIK1001 — Advanced Solid Tumor

VSTM · Jun 2027 (est.)

avutometinib — Pancreatic Ductal Adenocarcinoma (PDAC)

APRE · Jun 2027 (est.)

APR-246 + azacitidine — Advanced Solid Tumor

FTH · Jun 2027 (est.)

SNS-101 — Solid Tumor, Adult

IMMP · Jun 2027 (est.)

eftilagimod alfa — Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

INBX · Jun 2027 (est.)

INBRX-106 — Triple Negative Breast Cancer

IPHA · Jun 2027 (est.)

Monalizumab — Non Small Cell Lung Cancer

JAZZ · Jun 2027 (est.)

CPX-351 — Acute Myeloid Leukemia

SMMT · Jun 2027 (est.)

Ivonescimab — Thymus Carcinoma

IMNN · Jun 2027 (est.)

IMNN-001 — Ovarian Cancer

INDP · Jun 2027 (est.)

Decoy20 — Solid Tumor, Adult

LEGN · Jun 2027 (est.)

LCAR-B38M CAR-T Cell — Relapsed/Refractory B-cell Malignancies

PBYI · Jun 2027 (est.)

neratinib — Hormone Receptor Positive HER-2 Negative Breast Cancer

ACRS · Jun 2027 (est.)

A-101 — Metastatic Pancreatic Ductal Adenocarcinoma

BPTH · Jul 2027 (est.)

BP1001 in combination with Ventoclax plus decitabine — Solid Tumor, Adult

KPTI · Jul 2027 (est.)

Selinexor — Relapse Multiple Myeloma

KRYS · Jul 2027 (est.)

KB803 — Cancer

ANL · Jul 2027 (est.)

Buparlisib & Paclitaxel — Advanced Solid Tumor (Phase 1)

ONCY · Jul 2027 (est.)

REOLYSIN — Anal Cancer Metastatic

TPST · Jul 2027 (est.)

TPST-1120 — Advanced Liver Cancers

MAIA · Jul 2027 (est.)

6-Thio-2'-Deoxyguanosine — Carcinoma, Non-Small -Cell Lung

SMMT · Aug 2027 (est.)

Ivonescimab — Advanced Head and Neck Squamous Cell Carcinoma

TLX · Aug 2027 (est.)

177Lu-TLX591 — Clear Cell Renal Cell Carcinoma (ccRCC)

ZLAB · Aug 2027 (est.)

ZL-1310 — Solid Tumors

ADCT · Aug 2027 (est.)

Loncastuximab Tesirine — Follicular Lymphoma

ASND · Aug 2027 (est.)

TransCon CNP — Advanced Solid Tumor

NVCR · Aug 2027 (est.)

Temozolomide — Adenocarcinoma of Lung

BBOT · Aug 2027 (est.)

BBO-11818 — Non-Small Cell Lung Cancer

CLLS · Aug 2027 (est.)

UCART22 — B-cell Non-Hodgkin Lymphoma (B-NHL)

JNJ · Aug 2027 (est.)

Talquetamab — Multiple Myeloma

SMMT · Aug 2027 (est.)

Ivonescimab — Biliary Tract Cancer

VIR · Aug 2027 (est.)

VIR-5818 — Locally Advanced or Metastatic HER2-Expressing Cancers

VSTM · Aug 2027 (est.)

avutometinib — Thyroid Cancer

NVCR · Aug 2027 (est.)

Temozolomide — Pancreatic Adenocarcinoma

ONCY · Aug 2027 (est.)

REOLYSIN — Ras-mutated Metastatic Colorectal Cancer

CRDF · Aug 2027 (est.)

Onvansertib — Small-cell Lung Cancer

BNTX · Aug 2027 (est.)

ONC-392 — Non Small Cell Lung Cancer

CHRS · Sep 2027 (est.)

CHS-1420 — Hepatocellular Carcinoma

CORT · Sep 2027 (est.)

Relacorilant — Adenocarcinoma

IOVA · Sep 2027 (est.)

Lifileucel plus Pembrolizumab — Unresectable Melanoma

NEO · Sep 2027 (est.)

IO102-IO103 in combination with pembrolizumab — Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

RZLT · Sep 2027 (est.)

Ersodetug — Tumor Hyperinsulinism (Tumor HI)

SMMT · Sep 2027 (est.)

Ivonescimab — Metastatic Esophageal Adenocarcinoma

TLSI · Sep 2027 (est.)

Pembrolizumab — Locally Advanced Pancreatic Adenocarcinoma

AGEN · Sep 2027 (est.)

Botensilimab — Metastatic Colorectal Cancer

ADPT · Sep 2027 (est.)

Bendamustine — Lymphoma

VIR · Sep 2027 (est.)

VIR-5500 — Hormone-refractory Prostate Cancer

MAIA · Sep 2027 (est.)

6-Thio-2'-Deoxyguanosine — Carcinoma, Non-Small-Cell Lung

ACTU · Sep 2027 (est.)

ING-41 — Pancreatic Adenocarcinoma

CORT · Oct 2027 (est.)

Relacorilant — Metastatic Breast Cancer

NVCR · Oct 2027 (est.)

Temozolomide — Pancreas Cancer

OGN · Oct 2027 (est.)

150μg CFA (Elonva®) at stimulation day (SD) 1 and 100μg CFA(Elonva®) at SD 5 — Esophagogastric Adenocarcinoma

AGEN · Oct 2027 (est.)

Balstilimab — Metastatic Prostate Cancer

APVO · Oct 2027 (est.)

ALG.APV-527 — Acute Myeloid Leukemia (AML)

ONC · Oct 2027 (est.)

Tislelizumab — Metastatic Gastric Adenocarcinoma

PBYI · Oct 2027 (est.)

neratinib — Small Cell Lung Cancer

TFX · Oct 2027 (est.)

Fresh Frozen Plasma — Cervix Cancer

TLX · Oct 2027 (est.)

177Lu-TLX591 — Advanced Cancer

CUE · Oct 2027 (est.)

CUE-101 — Oropharyngeal Squamous Cell Carcinoma

CHRS · Nov 2027 (est.)

CHS-1420 — Ovarian Cancer Stage IV

CRIS · Nov 2027 (est.)

chondrocyte-alginate gel suspension — Chronic Lymphocytic Leukemia

CRVS · Nov 2027 (est.)

Soquelitinib — Peripheral T-Cell Lymphoma, Not Otherwise Specified

ONC · Nov 2027 (est.)

BGB-3111 — B-cell Malignancies

SYK · Nov 2027 (est.)

Ropivacaine — Breast Cancer

AURA · Nov 2027 (est.)

Bel-sar — Choroidal Melanoma

CGEN · Nov 2027 (est.)

COM701 — Neoplasm

MYGN · Nov 2027 (est.)

Niraparib — Solid Tumor

CTMX · Nov 2027 (est.)

CX-072 — Solid Tumor, Adult

AKTS · Dec 2027 (est.)

AKY-1189 — Urothelial Carcinoma Bladder

ALLO · Dec 2027 (est.)

Fludarabine — Large B-cell Lymphoma

ADAG · Dec 2027 (est.)

ADG106 — HER2-negative Breast Cancer

VSTM · Dec 2027 (est.)

avutometinib — Endometrioid Cancer

TLX · Dec 2027 (est.)

177Lu-TLX591 — Metastatic Castration-resistant Prostate Cancer

STRO · Dec 2027 (est.)

Luveltamab tazevibulin — Head and Neck Squamous Cell Carcinoma HNSCC

SMMT · Dec 2027 (est.)

Ivonescimab — Extensive Stage Lung Small Cell Cancer

RVMD · Dec 2027 (est.)

RMC-6236 — NSCLC (Non-small Cell Lung Cancer)

RADX · Dec 2027 (est.)

RAD101 — Castration-Resistant Prostate Cancer (CRPC)

BCTX · Dec 2027 (est.)

SV-BR-1-GM — Breast Cancer

BPTH · Dec 2027 (est.)

BP1001 in combination with Ventoclax plus decitabine — Acute Myeloid Leukemia (AML)

INTS · Dec 2027 (est.)

INT230-6 — Sarcoma,Soft Tissue

KURA · Dec 2027 (est.)

Ziftomenib — Gastrointestinal Stromal Tumor (GIST)

LEGN · Dec 2027 (est.)

LCAR-B38M CAR-T Cell — Gastric Cancer

NUVL · Dec 2027 (est.)

Neladalkib — Locally Advanced Solid Tumor

RIGL · Dec 2027 (est.)

Fostamatinib Disodium — Pancreatic Ductal Adenocarcinoma (PDAC)

PYXS · Dec 2027 (est.)

PYX-201 — Advanced Solid Tumors

SNDX · Dec 2027 (est.)

Revumenib — Acute Myeloid Leukemia

We don't show an approval percentage for these cancer & oncology catalysts — here's why.