Johnson & Johnson/Legend Biotech Corp.’s Carvykti (ciltacabtagene autoleucel) leapfrogged its multiple myeloma rival Abecma (idecabtagene vicleucel) with a new second-line multiple myeloma indication just one day after the US Food and Drug Administration cleared the Bristol Myers Squibb Company/2seventy Bio, Inc. therapy for third-line and later use.
J&J’s Carvykti Claims Broadest CAR-T Label In Multiple Myeloma
The second-line indication comes with safety labeling recently approved for BCMA-targeted CAR-T competitor Abecma, particularly around increased early mortality and secondary malignancies.

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PharmaMar, which wants to use the Jazz Pharmaceuticals-partnered drug, lurbinectedin, in combination with Roche’s Tecentriq for treating extensive-stage small cell lung cancer, is one of two companies that this month sought an accelerated assessment of their planned EU marketing applications.
Failing to meet the 29 April user fee date for the Barth syndrome treatment, and CDER’s request for a delay in responding to Vanda’s appeal of a tradipitant complete response letter, suggest a slowdown in review work due to layoffs and other recent changes.
The company’s failure to show its potency assays measured attributes directly related to the mesenchymal stromal cell product’s therapeutic effect highlights the importance of a robust CMC program for complex cell therapies.