US FDA's Cancer Review Staff Should All Move To Oncology Center of Excellence, Advocates Say

16 Mar 2018

• By Michael Cipriano

CDER's OHOP, as well as relevant CBER and CDRH staff, should be folded into OCE, which should have final sign-off on all oncology products, ASCO and Friends of Cancer Research say.

A restructuring of staff within the US FDA to strengthen the Oncology Center of Excellence (OCE) is one of the primary changes that advocates want to see in the agency's intercenter institute.

At an OCE listening session March 15, several external stakeholders commented to FDA staff that they would like to see all Office of Hematology and Oncology Products (OHOP) staff from the Center for Drug Evaluation and Research (CDER) be moved into OCE

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Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

21 May 2025

• By Bridget Silverman

The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.

STARGLO Dulled: Genentech’s Columvi Data Not Generalizable To US Patients, FDA Panel Says

20 May 2025

• By Sue Sutter

The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.