FDA grants accelerated approval to zenocutuzumab-zbco for NSCLC and pancreatic adenocarcinoma

Janet Woodcock, Paul Kim join Friends’ board of directors

Janet WoodcockPaul T. KimJanet Woodcock, former director of the Center for Drug Evaluation and Research at FDA, and Paul T. Kim, principal of Kendall Square Policy Strategies LLC, were appointed to the board of directors at Friends of Cancer Research.

January 24, 2025

Vol.51 No.03

Drugs & Targets

FDA grants RP1 BLA priority review for advanced melanoma

FDA has accepted the Biologics License Application from Replimune Group Inc. for RP1 (vusolimogene oderparepvec) in combination with nivolumab (Opdivo) for patients with advanced melanoma.

January 24, 2025

Vol.51 No.03

Guest Editorial

FDA and OHRP draft guidance aims to improve ethics of tissue biopsies in clinical trials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Drug Administration and the U.S. Department of Health and Human Services Office of Human Research Protections issued Draft Guidance on the inclusion of tissue biopsies in clinical trials.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

Clinical Roundup

ctDNA levels linked to recurrence risk in lung cancer, study finds

Personalis, Inc., in collaboration with professor Charles Swanton and his colleagues at London’s Francis Crick Institute and University College London, published new results from their TRACERx lung cancer study in Nature Medicine.

January 17, 2025

Vol.51 No.02

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

FDA grants accelerated approval to zenocutuzumab-zbco for NSCLC and pancreatic adenocarcinoma

YOU MAY BE INTERESTED IN

Janet Woodcock, Paul Kim join Friends’ board of directors

FDA grants RP1 BLA priority review for advanced melanoma

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

ctDNA levels linked to recurrence risk in lung cancer, study finds

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

Renew today!

Subscriber content

Never miss an issue!

Login