Europe Approves Bristol Myers Squibb's CAR-T Therapy For Early Treatment Of Type Of Blood Cancer

Wednesday, the European Commission approved Bristol Myers Squibb & Co’s BMY Abecma (idecabtagene vicleucel; ide-cel) for relapsed and refractory multiple myeloma who have received at least two prior therapies and have demonstrated disease progression on the last therapy. 

Abecma is the first chimeric antigen receptor (CAR) T cell immunotherapy approved in the European Union for use in earlier lines of therapy for relapsed and refractory multiple myeloma. 

Based on the KarMMa-3 study, Abecma is also the first cell therapy approved in Switzerland for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapies and the first cell therapy approved in Japan for adult patients with triple-class exposed relapsed or refractory multiple myeloma after two prior lines of therapy.

Abecma is also approved in the U.S. for adult patients with triple-class exposed relapsed or refractory multiple myeloma after four or more prior lines of therapy and in Great Britain and Israel for adult patients with triple-class exposed relapsed and refractory multiple myeloma after three or more prior lines of therapy. 

A supplemental Biologics License Application for Abecma for triple-class exposed relapsed and refractory multiple myeloma is under FDA review.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) recently voted favorably that Abecma demonstrated a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma based on the pivotal Phase 3 KarMMa-3 study results.

Wednesday, Bristol Myers Squibb announced topline data from the Phase 3 CheckMate -9DW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for advanced hepatocellular carcinoma.

The dual immunotherapy combination of Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to the investigator’s choice of sorafenib or lenvatinib. 

Price Action: BMY shares are up 0.29% at $52.03 during the premarket session on the last check Thursday.

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