Immuno-Oncology

The FDA cleared narsoplimab for TA-TMA, an NDA seeking approval of bezuclastinib in nonadvanced systemic mastocytosis has been submitted, and more.

China’s NMPA approved ipilimumab N01 plus sintilimab as neoadjuvant therapy for stage IIB to III resectable MSI-H/dMMR colon cancer.

The FDA approved subcutaneous mosunetuzumab for relapsed/refractory follicular lymphoma and granted a pair of breakthrough therapy designations.

The FDA approved T-DXd plus pertuzumab in HER2+ breast cancer, subcutaneous amivantamab in EGFR+ NSCLC, and rucaparib in BRCA-mutated mCRPC.

Experts reflect on pivotal data, emerging agents, and highly-anticipated trends spanning CML, CLL, B-cell lymphomas, and other hematologic malignancies.

The FDA approved Akeega for use in BRCA2+ mCSPC, granted priority review to the sBLA for nivolumab plus AVD in classical Hodgkin lymphoma, and more.

Both the phase 3 STAR-221 trial and phase 2 EDGE-Gastric studies of domvanalimab plus zimberelimab in upper GI cancers are being discontinued.

Adjuvant pembrolizumab delivers sustained clinical benefits across ccRCC subgroups with no new long-term safety signals.

PLN-101095 in combination with pembrolizumab led to responses in patients with ICI-refractory advanced solid tumors.

The prescribing information for cosibelimab in advanced cutaneous squamous cell carcinoma was updated to include long-term data from the CK-301-101 trial.

In case you missed any, read a recap of every episode of OncLive On Air that aired in November 2025.

Here is your cheat sheet to all therapeutic options that were cleared by the FDA in November 2025 spanning tumor types.

Pembrolizumab obtained approval from the European Commission for subcutaneous administration for all adult indications.

The FDA approved a new option in resectable gastric cancer, and a new agent is under priority review in mantle cell lymphoma.

Vicky Makker, MD, discusses the DESTINY-Endometrial01 trial of T-DXd plus rilvegostomig or pembrolizumab in HER2+ pMMR endometrial cancer.

The FDA approved durvalumab plus FLOT for the perioperative treatment of resectable gastric and gastroesophageal junction cancers.

Subcutaneous toripalimab generated non-inferior efficacy and safety outcomes vs the IV formulation in recurrent/metastatic non squamous NSCLC.

Sacituzumab tirumotecan plus pembrolizumab improved PFS as first-line treatment in PD-L1–positive advanced NSCLC.

The FDA approved 5 therapeutic options spanning lung cancer, urothelial cancer, NF1-associated PNs, and AL amyloidosis.

The FDA has approved neoadjuvant/adjuvant enfortumab vedotin plus pembrolizumab for cisplatin-ineligible muscle-invasive bladder cancer.

Cemiplimab wins EU approval after C-POST shows DFS gains for high-risk CSCC, marking the first effective adjuvant immunotherapy option.

The FDA has approved ziftomenib for NPM1-positive acute myeloid leukemia, has accepted a NDA for 177Lu-edotreotide for GEP-NETs, and more.

Researchers at The University of Texas MD Anderson Cancer Center shared insights about how the immune system can be trained to improve patient outcomes.

The FDA clears subcutaneous daratumumab in smoldering myeloma, adds REMS guidelines for pexidartinib in TGCT, and more.

The FDA has granted orphan drug designation to M2T-CD33 for the treatment of patients with acute myeloid leukemia.