Platinum drugs are off the shortage list, but the underlying problem is unsolved FDA’s Califf: “We have a market failure due to unwillingness of health systems and cancer centers to pay a fair price.”

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

Cancer Policy

Federal judge orders temporary block on 340B drug rebate pilot program

A federal judge has blocked the Health Resources and Services Administration from rolling out a pilot program that would reimburse safety net hospitals that get a discount on drugs through the 340B program via a rebate, as opposed to the status quo of up-front savings. The preliminary injunction was issued on Dec. 29, just a few days before the program was slated to begin on Jan 1.

FDA approves Rybrevant Faspro for EGFR-mutated NSCLC

FDA approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously administered therapy for patients with epidermal growth factor receptor-mutated non-small cell lung cancer.

January 09, 2026

Vol.52 No.1

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

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

Platinum drugs are off the shortage list, but the underlying problem is unsolved

FDA’s Califf: “We have a market failure due to unwillingness of health systems and cancer centers to pay a fair price.”

YOU MAY BE INTERESTED IN

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

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

Federal judge orders temporary block on 340B drug rebate pilot program

FDA approves Rybrevant Faspro for EGFR-mutated NSCLC

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

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

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