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Novartis Receives CHMP Positive Opinion for Kymriah to Treat Follicular Lymphoma

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Novartis Receives CHMP Positive Opinion for Kymriah to Treat Follicular Lymphoma

Novartis Receives CHMP Positive Opinion for Kymriah to Treat Follicular Lymphoma

Shots:

  • The recommendation was based on the P-II (ELARA) clinical study evaluating the safety & efficacy of Kymriah CAR-T cell therapy in patients with r/r FL after 2L+ systemic therapy
  • After a median follow-up of 17mos. the efficacy results showed 86% had a response inc. CR (69%), 87% patients who showed CR still in response 9mos. after initial response demonstrated a prolonged durable response to treatment. The safety results within 8wks. of infusions showed 49% of CRS with no high-grade CRS
  • The therapy is approved for the treatment of pediatric/young adults aged ≥25yrs. with r/r B cell ALL & for adults with r/r DLBCL. After the EC approval, r/r FL will be the third indication for Kymriah therapy in EU member states

Ref: Novartis | Image: Novartis 

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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