FDA grants priority review to HER2-directed therapy as first-line treatment of HER2-positive metastatic breast cancer

When “safe and effective” is not “reasonable and necessary”
We can curb excessive drug dosing and improve the quality of cancer care

By law, the Food and Drug Administration is required to determine whether a drug, device, biologic, or medical device is “safe and effective.” But the FDA determination does not control whether the Centers for Medicare & Medicaid Services will pay for it. To satisfy CMS, medical products and services must be “reasonable and necessary,” meaning...

January 16, 2026

Vol.52 No.02

By Mark J. Ratain and David A. Hyman

Cancer Policy

FDA releases 10 guiding principles for AI use in drug development

FDA, in collaboration with the European Medicines Agency, has published 10 principles to help guide pharmaceutical companies using artificial intelligence to develop drug, biological, and medical devices.

FDA to increase regulatory flexibility for development of cell and gene therapies

FDA has released additional information on its “flexible approach” to regulating chemistry, manufacturing and control, or CMC, requirements for cell and gene therapies.

FDA accepts NDA for pimicotinib for treatment of tenosynovial giant cell tumor

FDA accepted the new drug application for pimicotinib (ABSK021) as a systemic treatment for patients with tenosynovial giant cell tumor.

January 16, 2026

Vol.52 No.02

Cancer Policy

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

FDA grants priority review to HER2-directed therapy as first-line treatment of HER2-positive metastatic breast cancer

YOU MAY BE INTERESTED IN

When “safe and effective” is not “reasonable and necessary”
We can curb excessive drug dosing and improve the quality of cancer care

FDA releases 10 guiding principles for AI use in drug development

FDA to increase regulatory flexibility for development of cell and gene therapies

FDA accepts NDA for pimicotinib for treatment of tenosynovial giant cell tumor

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

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

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FDA grants priority review to HER2-directed therapy as first-line treatment of HER2-positive metastatic breast cancer

YOU MAY BE INTERESTED IN

When “safe and effective” is not “reasonable and necessary”We can curb excessive drug dosing and improve the quality of cancer care

FDA releases 10 guiding principles for AI use in drug development

FDA to increase regulatory flexibility for development of cell and gene therapies

FDA accepts NDA for pimicotinib for treatment of tenosynovial giant cell tumor

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

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

Never miss an issue!

Login

When “safe and effective” is not “reasonable and necessary”
We can curb excessive drug dosing and improve the quality of cancer care