September 26, 2024

FDA Approves Osimertinib in Stage III NSCLC After Chemoradiotherapy

The U.S. Food and Drug Administration approved osimertinib (Tagrisso) for adults with locally advanced, unresectable (stage III) non–small cell lung cancer (NSCLC) whose disease has not progressed dur...

The ASCO Post

September 18, 2024

FDA Draft Guidance on Conducting Multiregional Oncology Clinical Trials

The U.S. Food and Drug Administration (FDA) issued a draft guidance to provide sponsors with recommendations for conducting multiregional clinical trials in support of applications for drugs intended ...

The ASCO Post

September 18, 2024

FDA Approves Pembrolizumab With Chemotherapy for Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma

The U.S. Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda) with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant ple...

The ASCO Post

September 06, 2024

FDA Approves Ready-to-Use Version of Bortezomib for Subcutaneous Administration

The FDA has approved a new presentation of bortezomib (Boruzu) for ready-to-use subcutaneous or intravenous administration. This proteasome inhibitor is used for the treatment of multiple myeloma and ...

The ASCO Post

July 18, 2023

First Oral Medication to Treat Moderate-to-Severe Crohn’s Disease Earns FDA Approval

Upadacitinib, the first oral treatment for Crohn's disease, has been approved by the Food and Drug Administration. The approval came in part through a Mount Sinai-led clinical trial that showed it to be more efficacious than placebo.

Mount Sinai New York

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

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

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