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Home › Condition › Cancer & Oncology

Upcoming Cancer & Oncology FDA decisions & readouts

Updated ยทnext FDA decision on the calendar
PDUFA target dates and trial readouts in cancer & oncology, each linked to its primary source. Updated from FDA/SEC/ClinicalTrials.gov; dates can shift.
Obesity & MetabolicCNS & NeurologyImmunology & InflammationCardiovascularRare DiseaseInfectious Disease & VaccinesHematologyOphthalmology & Eye

PDUFA decisions (11)

RHHBY · 2026-10-09
Tecentriq (atezolizumab) adjuvant - (stage III colon): Adjuvant stage III dMMR/MSI-H colon cancer
MRK · 2026-10-10
Ifinatamab deruxtecan (I-DXd): Extensive-stage small cell lung cancer
NVCR · 2026-11-15
TTFields therapy (Optune) - brain metastases from NSCLC: Brain metastases from non-small cell lung cancer (PMA, Breakthrough Device)
GSK · 2026-11-27
Neladalkib (NVL-655) - (ALKOVE-1): TKI-pretreated ALK-positive NSCLC
COGT · 2026-11-30
Bezuclastinib + sunitinib - (PEAK): Gastrointestinal stromal tumors (GIST), 2L+
RHHBY · 2026-11-30
Giredestrant (lidERA): Adjuvant early breast cancer (ER+/HER2-)
EXEL · 2026-12-03
Zanzalintinib (XL092) + atezolizumab - (STELLAR-303): 2L metastatic colorectal cancer
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
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 (37)

GILD · Sep 2026 (est.)
Sacituzumab Govitecan
IBRX · Sep 2026 (est.)
ALT-803
MRK · Sep 2026 (est.)
Pembrolizumab
MRK · Oct 2026 (est.)
Pembrolizumab
OLMA · Oct 2026 (est.)
Palazestrant
RCUS · Oct 2026 (est.)
Zimberelimab
CRDF · Nov 2026 (est.)
Onvansertib
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
PBYI · Dec 2026 (est.)
neratinib
SMMT · Dec 2026 (est.)
Ivonescimab
XNCR · Dec 2026 (est.)
XMAB20717
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
IDYA · Apr 2027 (est.)
Darovasertib
REGN · Apr 2027 (est.)
Cemiplimab
SMMT · Apr 2027 (est.)
Ivonescimab
REGN · May 2027 (est.)
Cemiplimab
IMMP · Jun 2027 (est.)
eftilagimod alfa
ONCY · Jul 2027 (est.)
REOLYSIN
AGEN · Sep 2027 (est.)
Botensilimab
TLX · Oct 2027 (est.)
177Lu-TLX591
IOVA · Nov 2027 (est.)
Lifileucel plus Pembrolizumab
ADAG · Dec 2027 (est.)
ADG106
LEGN · Dec 2027 (est.)
LCAR-B38M CAR-T Cell
SMMT · Dec 2027 (est.)
Ivonescimab
TLX · Dec 2027 (est.)
177Lu-TLX591

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.