Six novel meds backed for approval by EMA's CHMP

At its June meeting, the European Medicines Agency’s human medicines committee (CHMP) recommended six novel medicines for approval, and issued a negative opinion on one.

The CHMP’s positive opinions will now be referred to the European Commission, which will decide whether to grant a marketing authorization, which usually takes two to three months.

The Committee recommended granting a conditional marketing authorization for Bristol Myers Squibb’s (NYSE: BMY) Abecma (idecabtagene vicleucel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three previous therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose cancer has worsened since receiving the last treatment. As Abecma is a gene therapy, the CHMP’s positive opinion is based on an assessment by EMA’s Committee for Advanced Therapies (CAT).