FDA approves Tecentriq Hybreza for subcutaneous PD-(L)1 cancer immunotherapy

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FDA and OHRP draft guidance aims to improve ethics of tissue biopsies in clinical trials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Drug Administration and the U.S. Department of Health and Human Services Office of Human Research Protections issued Draft Guidance on the inclusion of tissue biopsies in clinical trials.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

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

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

FDA approves Tecentriq Hybreza for subcutaneous PD-(L)1 cancer immunotherapy

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

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

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

FDA approves acalabrutinib + bendamustine and rituximab for mantle cell lymphoma

Renew today!

Subscriber content

Never miss an issue!

Login