News Briefs: Oncopeptides AB is withdrawing Pepaxto from the U.S. market | Nov. 16, 2021

Oncopeptides AB is voluntarily withdrawing Pepaxto (melphalan flufenamide) from the U.S. market, the company disclosed on Oct. 22. The FDA gave the therapy accelerated approval on Feb. 26, 2021, in combination with dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one CD38-directed monoclonal antibody. The company said that the decision follows the Phase III OCEAN study, which “the FDA does not consider…meets the criteria of a confirmatory study.”

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy (formerly called Specialty Pharmacy News) since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at HemAware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

Related Posts

https://www.mmitnetwork.com/wp-content/uploads/2021/11/WordPress-Featured-Image-radar-on-specialty-pharmacy-Another-Immunotherapy-Indication-Will-Be-Withdrawn.jpg
November 16

FDA Grants Interchangeable Status to Humira Biosimilar; Payers Should Prepare Now for 2023 Launches

READ MORE
https://www.mmitnetwork.com/wp-content/uploads/2021/10/WordPress-Featured-Image_NSCLC.jpg
November 16

New Tecartus FDA Approval for Adults With ALL Offers Welcome Therapeutic Option

READ MORE
https://www.mmitnetwork.com/wp-content/uploads/2021/11/WordPress-Featured-Image-radar-on-specialty-pharmacy-Specialty-Trend-Increase-Slows-Biosimilars-Are-Having-Impact.jpg
November 16

Prime Therapeutics Launches IntegratedRx – Oncology, Partners on MIP Accreditation

READ MORE

GAIN THERAPEUTIC AREA-SPECIFIC INTEL TO DRIVE ACCESS FOR YOUR BRAND

Sign up for publications to get unmatched business intelligence delivered to your inbox.

subscribe today