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2020-08-06| R&DTrials & Approvals

Novartis’ Kymriah Headed Towards Third Approval for Follicular Lymphoma

by Sangeeta Chakraborty
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The first-ever FDA approved CAR T cell therapy, Kymriah, is on its way to bag a potential third authorization for refractory and relapsing (r/r) follicular lymphoma (FL) based on the exciting primary endpoint results from the ELARA trial.

By Sangeeta Chakraborty, Ph.D.

On August 4th, Novartis announced positive data from an interim analysis of the ELARA trial. While the details are still under wraps, the company is going to present the results at an upcoming medical meeting. Regulatory submissions with the FDA and the EU are anticipated sometime in 2021, which will include the details of the Phase 2 trial.

“We are pleased that Kymriah (tisagenlecleucel) is showing meaningful results and may provide a potentially definitive treatment option for patients with relapsed and refractory follicular lymphoma,” said John Tsai, MD, Head of Global Drug Development and CMO at Novartis, in a press release. “These results further support our efforts to reimagine medicine in this incurable malignancy and reach this underserved patient population, who are historically burdened with several years of various treatments.”

 

ELARA Trial

Novartis tested the efficacy and safety of Kymriah in the open-label multicenter, single-arm Phase 2 study in patients with relapsed or refractory follicular lymphoma who have had previous treatments but their cancer either relapsed or became unresponsive. The study met its primary endpoint of complete response rate (CRR), as assessed by an independent review committee. Kymriah produced no new safety signals in the study.

Earlier in the second quarter of 2020, Kymriah was granted the regenerative medicine advanced therapy (RMAT) designation from the FDA based on the preliminary results from the trial. RMAT designation will allow an expedited development and review of Kymriah as a regenerative therapy for patients who are battling this incurable lymphoma.

 

Follicular Lymphoma

Follicular lymphoma is an indolent – or slow-growing – form of B-cell non-Hodgkin’s lymphoma (NHL) and accounts for 22% of NHL cases. Despite new treatments, FL repeatedly relapses and remits, with patients requiring almost a median of five lines of treatment and as many as twelve.

Kymriah was first approved back in 2017 for acute lymphoblastic leukemia (ALL) in children and young adults (up to 25 years of age). Later in May 2018, the therapy won approval for treatment of relapsing or refractory adult diffuse large B-cell lymphoma (DLBCL).

Kymriah was developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania. With RMAT designation and positive ELARA results solidly backing this CAR T-cell therapy, Novartis is hopeful of winning the FDA nod for the third time for treatment of r/r FL, securing a firm foothold for Kymriah against Gilead Science’s rival Yescarta in the CAR T race.

Related Article: CAR-T Therapy – a Boon for Cancer Treatment?

References
  1. https://www.novartis.com/news/media-releases/novartis-announces-kymriah-meets-primary-endpoint-interim-analysis-pivotal-study-follicular-lymphoma

 

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