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

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 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

January 17, 2025

FDA Approves Datopotamab Deruxtecan-dlnk for Advanced HR-Positive, HER2-Negative Breast Cancer

Today, the FDA approved a TROP-2–directed antibody and topoisomerase inhibitor conjugate for adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer ...

The ASCO Post

June 21, 2023

FDA Launches Pilot Program to Help Reduce Risks Associated With Using Laboratory Developed Tests to Identify Cancer Biomarkers

The U.S. Food and Drug Administration (FDA) announced a new voluntary pilot program to help physicians select safe and effective cancer treatments, with guidance on in vitro companion diagnostic tests...

The ASCO Post

November 17, 2023

FDA Approves Capivasertib With Fulvestrant for Breast Cancer

On November 16, 2023, the U.S. Food and Drug Administration (FDA) approved capivasertib (Truqap) with fulvestrant for adult patients with hormone receptor–positive, HER2-negative locally advanced or m...

The ASCO Post