FDA approves acalabrutinib + bendamustine and rituximab for mantle cell lymphoma

FDA and OHRP draft guidance aims to improve ethics of tissue biopsies in clinical trials

The U.S. Food and Drug Administration and the U.S. Department of Health and Human Services Office of Human Research Protections issued Draft Guidance on the inclusion of tissue biopsies in clinical trials.

January 17, 2025

Vol.51 No.02

By Laura A. Levit, Mark J. Ratain, Julie R. Gralow, Clifford A. Hudis and Elizabeth Garrett-Mayer

Drugs & Targets

FDA approves sotorasib + panitumumab for KRAS G12C-mutated colorectal cancer

FDA approved sotorasib (Lumakras) with panitumumab (Vectibix) for adult patients with KRAS G12C-mutated metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

January 17, 2025

Vol.51 No.02

Drugs & Targets

FDA issues proposed rule to limit nicotine in cigarettes

FDA issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the level of nicotine in those products. If finalized, the United States would be the first country globally to take such a bold, life-saving action to prevent and reduce smoking-related disease and death.

January 17, 2025

Vol.51 No.02

Drugs & Targets

FDA revokes authorization of Red No. 3 in food and ingested drugs

FDA is revoking the authorization for the use of FD&C Red No. 3 as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. FDA is amending its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition.

January 17, 2025

Vol.51 No.02

Drugs & Targets

FDA grants Rare Pediatric Disease designation for THIO in pediatric high-grade gliomas

FDA granted Rare Pediatric Disease designation for THIO in pediatric-type diffuse high-grade gliomas.

January 17, 2025

Vol.51 No.02

Conversation with The Cancer Letter

After 25 years as FDA’s chief cancer strategist, Richard Pazdur reflects on opportunities for change at the agency

In 1999, Richard Pazdur, a GI oncologist at MD Anderson, saw an FDA recruitment ad in The New England Journal of Medicine. The agency was looking for a director of the FDA Division of Oncology Drug Products.

January 10, 2025

Vol.51 No.01

By Paul Goldberg

FDA approves acalabrutinib + bendamustine and rituximab for mantle cell lymphoma

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FDA and OHRP draft guidance aims to improve ethics of tissue biopsies in clinical trials

FDA approves sotorasib + panitumumab for KRAS G12C-mutated colorectal cancer

FDA issues proposed rule to limit nicotine in cigarettes

FDA revokes authorization of Red No. 3 in food and ingested drugs

FDA grants Rare Pediatric Disease designation for THIO in pediatric high-grade gliomas

After 25 years as FDA’s chief cancer strategist, Richard Pazdur reflects on opportunities for change at the agency

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