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Novartis’ Kymriah (tisagenlecleucel) CAR-T Cell Therapy Receives the US FDA’s Approval for the Treatment of Follicular Lymphoma

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Novartis’ Kymriah (tisagenlecleucel) CAR-T Cell Therapy Receives the US FDA’s Approval for the Treatment of Follicular Lymphoma

Novartis’ Kymriah (tisagenlecleucel) CAR-T Cell Therapy Receives the US FDA’s Approval for the Treatment of Follicular Lymphoma

Shots:

  • The approval was based on the P-II (ELARA) trial evaluating Kymriah in 90 adult patients with r/r FL after ≥2 lines of systemic therapy for ~17mos. of median follow-up
  • The results showed that 68% of patients achieved CR with ORR (86%) along with a remarkable safety profile, 85% were still in response @12mos. with sustained clinical benefit. The therapy was effective in high-risk patients including those with heavily pretreated or had refractory disease & other measures
  • The safety profile was remarkable in 97 patients for safety @21mos. of median follow-up, 53% & 43% achieved any-grade CRS & neurologic events with no high-grade CRS, grade ≥3 neurologic events (6%), 18% were infused in an outpatient setting

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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