Linvoseltamab BLA accepted for Priority Review for R/R multiple myeloma

My introduction to, and lessons learned from, Rick Pazdur

Rick Pazdur, MD, the newly appointed director for the Center for Drug Evaluation and Research at the FDA, has been described as “greyhound thin” as a result of his dedication to cycling and lifting weights in the gym each day and, for a long time, a vegetarian diet. I first met him when he was the director of the Office of Oncology Drug Products (ODP) within CDER, in 2009.

November 21, 2025

Vol.51 No.43

By Mikkael A. Sekeres

Cancer Policy

Makary, Prasad describe FDA’s new “plausible mechanism pathway” to get bespoke therapies to market sans RCT

FDA Commissioner Marty Makary and Vinay Prasad, FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, jointly published a letter in The New England Journal of Medicine spelling out the rationale for FDA’s new “plausible mechanism pathway,” aimed at getting bespoke therapies to market without the need for a randomized controlled trial.

UAMS Cancer Institute director Michael Birrer inducted into American Academy of Sciences and Letters

Academy President Donald W. Landry presents the American Academy of Sciences and Letters medal to Winthrop P. Rockefeller Cancer Institute Director Michael Birrer.Michael J. Birrer, director of the Winthrop P. Rockefeller Cancer Institute at the University of Medical Sciences, has been inducted as a member of the American Academy of Sciences and Letters.

November 21, 2025

Vol.51 No.43

Drugs & Targets

FDA grants full approval of Imdelltra in ES-SCLC

FDA granted full approval to Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. The decision to convert Imdelltra’s prior accelerated approval to a full approval is based on data from the global phase III DeLLphi-304 study.

November 21, 2025

Vol.51 No.43

Drugs & Targets

FDA approves Poherdy, first biosimilar to Perjeta, for breast cancer indication

FDA approved Poherdy (pertuzumab-dpzb) as an interchangeable biosimilar to Perjeta (pertuzumab). This is the first approval of a biosimilar for Perjeta.

November 21, 2025

Vol.51 No.43