April 24, 2025

FDA Approves Nivolumab With Ipilimumab for Unresectable or Metastatic MSI-H/dMMR Colorectal Cancer

The FDA approved the combination of a PD-1 inhibitor and a CTLA-4 inhibitor for patients with unresectable or metastatic microsatellite instability–high or mismatch repair–deficient colorectal cancer ...

The ASCO Post

April 24, 2025

Combination Immunotherapy Approved for Unresectable or Metastatic Hepatocellular Carcinoma

On April 11, 2025, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) with ipilimumab (Yervoy) for the first-line treatment of adults with unresectable or metastatic hepatocellul...

The ASCO Post

April 14, 2025

FDA Approves Bevacizumab Biosimilar

Bevacizumab-nwgd is indicated for use in the treatment of certain kinds of colorectal, lung, brain, kidney, and cervical cancers.

The ASCO Post

April 09, 2025

FDA Approves Nivolumab With Ipilimumab for Unresectable or Metastatic MSI-H/dMMR Colorectal Cancer

The FDA approved the combination of a PD-1 inhibitor and a CTLA-4 inhibitor for patients with unresectable or metastatic microsatellite instability–high or mismatch repair–deficient colorectal cancer ...

The ASCO Post

March 31, 2025

FDA Approves Perioperative Durvalumab for Muscle-Invasive Bladder Cancer

The FDA has approved the PD-L1 inhibitor durvalumab (Imfinzi) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment following radical cyste...

The ASCO Post

August 29, 2023

FDA Approves Luspatercept-aamt as First-Line Treatment for Adult Patients With Lower-Risk MDS and Anemia Who May Require Transfusions

On August 28, the U.S. Food and Drug Administration (FDA) approved luspatercept-aamt (Reblozyl) to treat anemia in adult patients with very low– to intermediate-risk myelodysplastic syndromes (MDS) wh...

The ASCO Post

February 21, 2024

FDA Approves Biweekly Teclistamab Dosing Regimen for Patients With Multiple Myeloma

On February 20, the FDA approved the supplemental biologics license application for teclistamab-cqyv (Tecvayli) for a reduced dosing frequency of 1.5 mg/kg every 2 weeks in patients with relapsed or r...

The ASCO Post

August 05, 2024

FDA Grants Accelerated Approval to T-Cell Therapy for Unresectable or Metastatic Synovial Sarcoma

On August 2, the FDA granted accelerated approval to afamitresgene autoleucel (Tecelra), a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T-cell immunotherapy, for a...

The ASCO Post

August 28, 2024

FDA Approves Cancer Biomarker Test, Companion Diagnostic Indications

The FDA has approved the in vitro diagnostic TruSight Oncology Comprehensive test and its first two companion diagnostic indications. This targeted sequencing panel interrogates over 500 genes to prof...

The ASCO Post