March 26, 2025

FDA Approves Cabozantinib for pNET and epNET

Today, the FDA approved the tyrosine kinase inhibitor cabozantinib (Cabometyx) for adult and pediatric patients aged 12 years and older with previously treated, unresectable, locally advanced or metas...

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

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

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

June 10, 2024

FDA Grants Accelerated Approval to Lisocabtagene Maraleucel for Relapsed or Refractory Follicular Lymphoma

On May 15, the FDA granted accelerated approval to lisocabtagene maraleucel (Breyanzi) for adult patients with relapsed or refractory follicular lymphoma who have received two or more prior lines of s...

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 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

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