Scientists advising the US medicines regulator will convene to discuss a submission to move Carvykti (ciltacabtagene autoleucel) into an earlier line of treatment.
Developed by US healthcare giant Johnson & Johnson (NYSE: JNJ) together with partner Legend Biotech (Nasdaq: LEGN), the product has been approved as a later-line option since 2022.
The BCMA-targeting CAR-T cell therapy, which is used to treat people with multiple myeloma, generated around $159 million in net sales in the final quarter of 2023.
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