Immuno-Oncology

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.

Seven provinces have agreed to reimburse cemiplimab for the treatment of patients with advanced non–small cell lung cancer and basal cell carcinoma.

Here is your guide to all therapeutic options that were approved by the FDA in October 2025 spanning tumor types.

Vepugratinib-based treatment was safe and active in FGFR3-altered metastatic urothelial cancer.

Jonathan Riess, MD, discusses data for IO102-IO103 plus pembrolizumab in advanced HSNCC and NSCLC with high PD-L1 expression.

The European Commission approved perioperative pembrolizumab plus adjuvant radiotherapy with or without cisplatin in resectable locally advanced HNSCC.

EVX-01 plus pembrolizumab generated an overall response rate of 75% and durable T-cell responses in advanced melanoma.

The FDA has cleared BVd for multiple myeloma and revumenib for NPM1-mutant AML, and granted priority review to perioperative enfortumab vedotin in MIBC.

Adjuvant cemiplimab significantly cut recurrence risk and improved disease-free survival in high-risk CSCC, establishing a new standard of care.

EIK1001 plus pembrolizumab and chemo showed a 64% ORR and manageable safety in first-line stage IV NSCLC, per phase 2 TeLuRide-005 data.

Enfortumab vedotin plus pembrolizumab demonstrated meaningful first-line clinical activity in PD-L1–positive recurrent or metastatic HNSCC.

NG-350A has been awarded fast track designation from the FDA for rectal cancer and is under further evaluation in the FORTRESS trial.

J. Thaddeus Beck, MD, FACP, discusses the FDA approval of subcutaneous pembrolizumab in solid tumors.

The FDA approved adjuvant cemiplimab in cutaneous squamous cell carcinoma, issued a CRL to dasatinib in chronic myeloid leukemia, and more.

Here is your Q4 2025 preview spotlighting 10 FDA decisions to watch, including upcoming PDUFAs for belantamab mafodotin, revumenib, sevabertinib, and more.

Early objective responses have been shown with JNJ-1900 plus immune checkpoint inhibitors for recurrent/metastatic HNSCC.

Here is your guide to all therapeutic options that were approved by the FDA in September 2025 spanning tumor types.

The top 5 OncLive TV videos of the week cover insights in solid tumors, breast cancer, pancreatic cancer, and multiple myeloma.

J. Thaddeus Beck, MD, FACP, discusses the FDA approval of subcutaneous pembrolizumab and berahyaluronidase for use across all adult and solid-tumor indications.