Heated discussion breaks out in recent meeting as FDA mulls standards for MCD approval Meanwhile, NCI trial will assess clinical utility

FDA and OHRP draft guidance aims to improve ethics of tissue biopsies in clinical trials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Drug Administration and the U.S. Department of Health and Human Services Office of Human Research Protections issued Draft Guidance on the inclusion of tissue biopsies in clinical trials.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

ACS report: Cancer mortality continues to drop despite rising incidence in women

Despite steady progress in reducing overall cancer mortality rates, cancer incidence in women is rising, according to the American Cancer Society’s “Cancer Statistics, 2025” report. Incidence rates in women 50-64 years of age have surpassed those in men, and rates in women under 50 are now 82% higher than their male counterparts, up from 51% higher in 2002. In 2021, for the first time, lung cancer incidence was higher in women under 65 than in men.

January 17, 2025

Vol.51 No.02

By Yiqing Wang

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 approves acalabrutinib + bendamustine and rituximab for mantle cell lymphoma

FDA approved acalabrutinib (Calquence) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation.

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

Heated discussion breaks out in recent meeting as FDA mulls standards for MCD approval

Meanwhile, NCI trial will assess clinical utility

YOU MAY BE INTERESTED IN

FDA and OHRP draft guidance aims to improve ethics of tissue biopsies in clinical trials

ACS report: Cancer mortality continues to drop despite rising incidence in women

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

FDA approves acalabrutinib + bendamustine and rituximab for mantle cell lymphoma

FDA issues proposed rule to limit nicotine in cigarettes

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

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