FDA investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous CAR T-cell immunotherapies

FDA and OHRP draft guidance aims to improve ethics of tissue biopsies in clinical trials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Drug Administration and the U.S. Department of Health and Human Services Office of Human Research Protections issued Draft Guidance on the inclusion of tissue biopsies in clinical trials.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

Clinical Roundup

Immunotherapy for pediatric osteosarcoma with lung metastases after resection shows positive data

OS Therapies Inc. announced positive data from a phase IIb clinical trial (NCT04974008) of OST-HER2 (OST31-164)—the company’s HER2-targeted immunotherapy candidate in the rare pediatric-designated indication of prevention of recurrent, fully resected, lung metastatic osteosarcoma.

January 17, 2025

Vol.51 No.02

Clinical Roundup

Scientists uncover protein that helps cancer cells dodge CAR T-cell therapy

Scientists at City of Hope identified a protein that could help prevent CAR T-cell therapy antigen escape. The research, published in the journal Cell, could lead to more personalized therapies that improve cancer patients’ survival.

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

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

FDA investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous CAR T-cell immunotherapies

YOU MAY BE INTERESTED IN

FDA and OHRP draft guidance aims to improve ethics of tissue biopsies in clinical trials

Immunotherapy for pediatric osteosarcoma with lung metastases after resection shows positive data

Scientists uncover protein that helps cancer cells dodge CAR T-cell therapy

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

Renew today!

Subscriber content

Never miss an issue!

Login