Johnson & Johnson Reports the US FDA ODAC’s Recommendation of Carvykti for Treating Relapsed/Refractory Multiple Myeloma
Shots:
- J&J’s Carvykti has received recommendation from the US FDA’s ODAC for treating RRMM. The sBLA based on the P-III (CARTITUDE-4) trial is under review with the decision expected on Apr 05, 2024
- The P-III (CARTITUDE-4) trial assessed the safety & efficacy of Carvykti vs pomalidomide, bortezomib & dexamethasone (PVd) or daratumumab, pomalidomide & dexamethasone (DPd) for treating relapsed MM patients, refractory to lenalidomide & previously treated with at least 1L of therapy (incl. PI & IMiD)
- Additionally, the CHMP’s positive opinion of the Type II variation application for Carvykti was based on the P-III (CARTITUDE-4) study results that were highlighted at ASCO 2023 and published in the NEJM
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
