Logo

Johnson & Johnson Reports the US FDA ODAC’s Recommendation of Carvykti for Treating Relapsed/Refractory Multiple Myeloma

Share this

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

Ref: Johnson & Johnson | Image: Johnson & Johnson

Related News:- Janssen and Legend Biotech Report the sBLA Submission of Carvykti (ciltacabtagene autoleucel) to the US FDA for Relapsed or Refractory Multiple Myeloma

PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com

Click here to­ read the full press release 

Disha Nankani

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.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions