Carvykti joins Abecma in EU expansion

Johnson & Johnson and Legend have already convinced the US FDA to approve their BCMA-targeting Car-T Carvykti in early lines of multiple myeloma, and today it was the European Commission’s turn to approve the therapy in second-line or later disease. Carvykti now joins Bristol Myers Squibb/2seventy’s Abecma, which got the EU nod for earlier-stage disease in March. Financials last week showed Carvykti sales flattening, but J&J said during its first-quarter earnings call that revenues should pick up in the second half of this year as it expands manufacturing capacity, which has already doubled since the start of 2023. Car-T manufacturing is also clearly front of Bristol’s mind: that group today announced a deal with Cellares over what it calls the “first end-to-end fully automated cell therapy manufacturing platform”. The agreement is worth up to $380m, but the companies didn’t disclose the up-front fee. Bristol is already familiar with Cellares, having participated in that group’s series C round last year and taken part in a technology adoption partnership programme.

Carvykti and Abecma approvals in early-line multiple myeloma

Source: company releases.