November 08, 2024

Tumor Treating Fields Therapy Receives FDA Approval in Metastatic NSCLC

Novocure recently announced the U.S. Food and Drug Administration (FDA) approval of Optune Lua® for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for the treatment of adults with metastatic n...

The ASCO Post

November 08, 2024

FDA Approves Novel Combination for Gastric or Gastroesophageal Junction Adenocarcinoma

The U.S. Food and Drug Administration approved zolbetuximab-clzb (Vyloy), a claudin 18.2-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line tr...

The ASCO Post

November 07, 2024

FDA Grants Accelerated Approval to Asciminib for Newly Diagnosed Chronic Myeloid Leukemia

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to the BCR::ABL1 kinase inhibitor asciminib (Scemblix) for adult patients with newly diagnosed Philadelphia chromosome–posi...

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

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

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

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