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Home › Condition › Cancer & Oncology

Upcoming Cancer & Oncology FDA decisions & readouts

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET
PDUFA target dates and trial readouts in cancer & oncology, each linked to its primary source. Updated from FDA/SEC/ClinicalTrials.gov; dates can shift.
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PDUFA decisions (13)

NVCR · 2026-11-15
TTFields therapy (Optune) - brain metastases from NSCLC: Brain metastases from non-small cell lung cancer (PMA, Breakthrough Device)
COGT · 2026-11-30
Bezuclastinib + sunitinib - (PEAK): Gastrointestinal stromal tumors (GIST), 2L+
GSK · Nov 2026 (est.)
Neladalkib (NVL-655) - (ALKOVE-1): TKI-pretreated ALK-positive NSCLC
RHHBY · 2026-11-30
Giredestrant (lidERA): Adjuvant early breast cancer (ER+/HER2-)
RHHBY · 2026-12-18
Giredestrant (+ everolimus): ER+/HER2-, ESR1-mutated metastatic breast cancer
GILD · 2026-12-23
Anito-cel (anitocabtagene autoleucel): Relapsed or refractory multiple myeloma (fourth-line), BCMA CAR-T
RHHBY · 2027-02-09
Lunsumio VELO (mosunetuzumab) + Polivy - relapsed/refractory LBCL (SUNMO): With Polivy (polatuzumab vedotin), relapsed or refractory large B-cell lymphoma after at least one prior line of systemic therapy
CGEM · 2027-02-27
Zipalertinib (CLN-081) - relapsed EGFR exon 20 insertion NSCLC: Relapsed EGFR exon 20 insertion non-small cell lung cancer
EXEL · 2027-03-03
Zanzalintinib (XL092) + atezolizumab - (STELLAR-303): 2L metastatic colorectal cancer
INBX · 2027-04-14
Ozekibart (INBRX-109) - conventional chondrosarcoma: Unresectable or metastatic conventional chondrosarcoma
IMNM · 2027-04-28
Varegacestat - desmoid tumors (RINGSIDE): Adults with desmoid tumors
URGN · 2027-06-14
UGN-103 (mitomycin) - low-grade intermediate-risk NMIBC: Low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)
MRK · 2027-06-15
Sacituzumab tirumotecan (sac-TMT) - endometrial cancer (TroFuse-005): Adults with endometrial cancer previously treated with platinum chemotherapy and a PD-1/PD-L1 inhibitor

Trial readouts (49)

ATOS · Nov 2026 (est.)
Z-Endoxifen
CRDF · Nov 2026 (est.)
Onvansertib
ACTU · Dec 2026 (est.)
Losartan
ADCT · Dec 2026 (est.)
Loncastuximab Tesirine
AGEN · Dec 2026 (est.)
Balstilimab
ARVN · Dec 2026 (est.)
ARV-471
BMY · Dec 2026 (est.)
Nivolumab
CRDF · Dec 2026 (est.)
Onvansertib
MRK · Dec 2026 (est.)
Pembrolizumab
SMMT · Dec 2026 (est.)
Ivonescimab
CRIS · Dec 2026 (est.)
NCT07271667 readout
KYNB · 2026-12-31
FG-3246 readout
SLGL · 2026-12-31
SGT-610 readout
SLS · 2026-12-31
SLS009 (tambiciclib) Phase 2 AML readout
SLS · 2026-12-31
REGAL Phase 3 (galinpepimut-S) topline, event-driven: Acute myeloid leukemia, maintenance in second complete remission (CR2)
APLM · Jan 2027 (est.)
Uproleselan
ELVN · Jan 2027 (est.)
ELVN-002
IDYA · Jan 2027 (est.)
Darovasertib
MRK · Feb 2027 (est.)
Pembrolizumab
ARVN · Mar 2027 (est.)
ARV-471
GILD · Mar 2027 (est.)
Sacituzumab Govitecan
IPHA · Mar 2027 (est.)
Monalizumab
AKTS · 2027-03-31
AKY-1189 readout
CRBP · 2027-03-31
CRB-701 readout
AIM · Apr 2027 (est.)
Ampligen
IDYA · Apr 2027 (est.)
Darovasertib
NBTX · Apr 2027 (est.)
NBTXR3
REGN · Apr 2027 (est.)
Cemiplimab
SMMT · Apr 2027 (est.)
Ivonescimab
REGN · May 2027 (est.)
Cemiplimab
TNGX · May 2027 (est.)
S095035
IMMP · Jun 2027 (est.)
eftilagimod alfa
INDP · Jun 2027 (est.)
Decoy20
ONCY · Jul 2027 (est.)
REOLYSIN
ASND · Aug 2027 (est.)
TransCon CNP
AGEN · Sep 2027 (est.)
Botensilimab
MAIA · Sep 2027 (est.)
6-Thio-2'-Deoxyguanosine
TLSI · Sep 2027 (est.)
SD-101
TLX · Oct 2027 (est.)
177Lu-TLX591
IOVA · Nov 2027 (est.)
Lifileucel plus Pembrolizumab
ADAG · Dec 2027 (est.)
ADG106
INTS · Dec 2027 (est.)
INT230-6
LEGN · Dec 2027 (est.)
LCAR-B38M CAR-T Cell
SMMT · Dec 2027 (est.)
Ivonescimab
TLX · Dec 2027 (est.)
177Lu-TLX591
ANL · 2027-12-31
AN4035 (CEACAM5 ADC) global Phase I: CEACAM5-enriched RAS-addicted solid tumors
KZIA · 2027-12-31
paxalisib Stage IV TNBC study: triple-negative breast cancer
TYRA · 2027-12-31
SURF303 Phase 2a/b initial results (LG-UTUC)
INBX · Jul 2033 (est.)
INBRX-106

Every upcoming FDA decision date, all therapeutic areas, on the 2026 PDUFA calendar · all conditions

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