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Autologous, BCMA, CAR-T

August 16, 2023

Carvykti’s sBLA in 2L MM Did Not Receive Priority Review; JNJ / Legend Continue To Improve Manufacturing Capacity; Updates on Solid Tumor Programs; Legend’s Q2 2023 Earnings Call Summary

Here is a brief preview of this blast: On Tuesday, August 15, Legend held its Q2 2023 earnings call (press release) highlighting that the FDA set a PDUFA date for Carvykti’s (BCMA CAR-T) sBLA in ≥2L MM on April 5, 2024. Moreover, management listed measures that the company is taking to improve its manufacturing capacity and reported updates on its solid tumor programs. Below, Celltelligence provides insights on the FDA’s standard review of Carvykti’s sBLA while discussing future development for Carvykti and the company’s solid tumor programs.