Clearing the path for MRD as early endpoint in multiple myeloma

OCE’s Project 5 in 5 seeks to inspire pragmatic innovation

If the FDA Oncology Center of Excellence (OCE) began an “innovation challenge” in oncology drug development, what would that look like?

May 10, 2024

Vol.50 No.19

By Steven C. Cunningham, Donna R. Rivera, Richard Pazdur, Kelly J. Norsworthy and Jennifer Gao

Drugs & Targets

FDA accepts BLA for subcutaneous Opdivo

FDA has accepted the Bristol Myers Squibb’s Biologics License Application for the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20)—herein referred to as “subcutaneous nivolumab”—across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.

May 10, 2024

Vol.50 No.19

Health Equity White House

Citing need for “more conversations” on menthol, White House scuttles move to ban the flavor favored by Black smokers

The Biden administration has—for the second time—delayed the decision on a proposed FDA rule that would ban menthol cigarettes and all flavors in cigars.

May 03, 2024

Vol.50 No.18

By McKenzie Prillaman

Drugs & Targets

FDA rule focuses on the safety and effectiveness of LDTs

FDA has finalized a rule to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised for many years.

May 03, 2024

Vol.50 No.18

Drugs & Targets

FDA issues additional draft guidance on eligibility criteria for cancer drug clinical trials

FDA issued three draft guidance documents on eligibility criteria in cancer clinical trials to address performance status, washout periods and concomitant medications, and laboratory values.

May 03, 2024

Vol.50 No.18

Regulatory News

ODAC unanimously upholds MRD as early endpoint across all settings in multiple myeloma

In a unanimous vote, the FDA Oncologic Drugs Advisory Committee advised the agency to accept the metric of “minimal residual disease,” or MRD, as a basis for accelerated approvals of therapies in all settings of multiple myeloma.

April 26, 2024

Vol.50 No.17

By Jacquelyn Cobb