The recent FDA-mandated box warning for all 6 approved CAR-T therapies on potential secondary malignancies gave a massive fright to everyone, from clinicians to patients and from drug developers to commercial marketeers.  Everyone was wondering if there’s now a viable clinical and commercial future for CAR-T therapy, especially if it is such a dangerous approach with expected Cytokine Release Syndrome (CRS) and potential fatal or life-threatening reactions.  Now that the box warnings have been issued (i.e. done and dusted right at the beginning of the year), has that dented the regulators’ appetite for CAR-T therapies?  Apparently not, and quite the opposite in fact.  Last week on the 22nd February 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use (EMA; CHMP) recommended that Carvykti’s marketing authorisation for patients with relapsed and refractory multiple myeloma (RRMM) be extended from the current three prior therapies to just one prior therapy and to patients refractory to lenalidomide.

This is a Bob Beamon jump indeed and means that this CAR-T has now moved from fourth-line to second-line treatment for RRMM.  The consequences are HUGE: RRMM patients can now have Carvykti after first-line treatment failure and it clearly opens up a previously untapped population in both the clinic and market for Carvykti.  I bet the guys at Legend Biotech and Janssen are pleased with this, and especially from the CARTITUDE-4 study which was in the data package for the CHMP submission.

READ THE ARTICLE – https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-carvykti-ii-21_en.pdf