October 02, 2025

FDA Removes Vandetanib REMS Program

On September 25, the U.S. Food and Drug Administration (FDA) removed the Risk Evaluation and Mitigation Strategies (REMS) program for vandetanib, according to an announcement from the agency. 

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

January 25, 2021

FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer

Today, the U.S. Food and Drug Administration approved relugolix (Orgovyx) for the treatment of adult patients with advanced prostate cancer. This is the first oral hormone therapy approved for this in...

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

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

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

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

August 16, 2024

FDA OCE Invites Pediatric Cancer Advocates to Meet on October 15

The FDA's Oncology Center of Excellence (OCE) Pediatric Oncology Program invites members of the pediatric cancer advocacy community to participate in the 2024 OCE Pediatric Advocacy Forum on October 1...

The ASCO Post