05.04.2024 16:04:28 - dpa-AFX: Bristol Myers, 2seventy Bio Get FDA Nod For Abecma For Relapsed Multiple Myeloma Patients

NEW YORK CITY (dpa-AFX) - Friday, Bristol Myers Squibb (BMY) and 2seventy
bio, Inc. (TSVT) announced they received the U.S. Food and Drug Administration
approval for Abecma for the treatment of adult patients with relapsed or
refractory multiple myeloma after two or more prior lines of therapy, based on
results of Phase 3, open-label KarMMa-3 trial.

Abecma is administered as a one-time infusion, with a new recommended dose range
of 300 to 510 x 106 CAR-positive T cells.

This approval expands Abecma's indication and it will be available to patients
who have relapsed or become refractory after exposure to these three main
classes of treatment, after two prior lines of therapy.

Bryan Campbell, Head of Commercial, Cell Therapy at Bristol Myers Squibb said,
'Abecma has demonstrated a progression-free survival benefit three times that of
standard regimens in relapsed or refractory multiple myeloma, and we are now
bringing the promise of cell therapy to patients earlier in their treatment
journey.'

Abecma was recently approved in Japan, Switzerland and the European Union for
adult patients with triple-class exposed relapsed and/or refractory multiple
myeloma after two prior lines of therapy. It is also currently approved 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.



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