FDA approves Rybrevant Faspro for EGFR-mutated NSCLC

Merck & Co. drug for treating NSCLC awarded FDA priority voucher

FDA has granted sacituzumab tirumotecan (sac-TMT), a trophoblast cell-surface antigen 2 directed antibody-drug conjugate, a priority voucher via the agency’s Commissioner’s National Priority Voucher (CNPV) Pilot Program.

January 09, 2026

Vol.52 No.1

By Claire Marie Porter

Cancer Policy

FDA-mandated report finds “insufficient data” to determine safety of PFAS in cosmetics

FDA has released a congressionally mandated report evaluating the use of perfluoroalkyl and polyfluoroalkyl substances in cosmetic products.

January 09, 2026

Vol.52 No.1

By Claire Marie Porter

Drugs & Targets

FDA grants Enhertu Breakthrough Therapy designation as post-neoadjuvant therapy for HER2+ early breast cancer

FDA granted breakthrough therapy designation to Enhertu (trastuzumab deruxtecan) for adult patients with HER2-positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment and high risk of disease recurrence.

January 09, 2026

Vol.52 No.1

Drugs & Targets

China NMPA approves Pimicotinib as systemic treatment in tenosynovial giant cell tumor

The China National Medical Products Administration approved pimicotinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause functional limitation or relatively severe morbidity.

January 09, 2026

Vol.52 No.1

Podcast

Otis Brawley looks back on a year of great science and greater challenges

In a year that brought us new KRAS-inhibiting drugs, deepened our understanding of HER2 in breast cancer, and highlighted new potential for mRNA vaccines, the cancer field was also rocked by uncertainty of the future of research funding, equity in cancer delivery, and the integrity of review at FDA.

December 31, 2025

Cancer Policy

Angelo de Claro named acting director of FDA Oncology Center of Excellence

Angelo de Claro was named acting director of the FDA Oncology Center of Excellence, following Richard Pazdur’s departure from that position—and the agency (The Cancer Letter, Dec. 5, 2025).

December 19, 2025

Vol.51 No.46

By Jacquelyn Cobb