Breaking News, Trials & Filings

FDA Accepts Novartis’ sBLA for Priority Review

For a new CAR-T cell therapy treatment

The FDA has accepted the Priority Review of Novartis’ supplemental Biologics License Application (sBLA) for Kymriah (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019. It’s for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT). 

 

In addition, the European Medicines Agency (EMA) has granted accelerated assessment to the Marketing Authorization Application (MAA) for Kymriah for the treatment of children and young adults with r/r B-cell acute lymphoblastic leukemia (ALL) and for adult patients with r/r DLBCL who are ineligible for ASCT. 

 

If approved by the FDA and EMA, Kymriah would represent the first chimeric antigen receptor T cell (CAR-T) therapy available for two distinct indications in non-Hodgkin lymphoma and B-cell ALL.

 

Kymriah became the first CAR-T cell therapy to receive regulatory approval when it was approved by the FDA in August 2017 for the treatment of patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse.

 

“The first approval of a CAR-T therapy truly redefined the future of the cancer treatment landscape, and we are only at the beginning of this new era in cancer care,” said Samit Hirawat, MD, head, Novartis Oncology Global Drug Development. “The Priority Review designation and accelerated assessment signal that the FDA and EMA have recognized the potential of Kymriah to provide a much-needed therapeutic option for these patients with relapsed or refractory B-cell ALL and DLBCL. We are now focused on working with these regulatory agencies to bring this potentially transformative therapy to more patients.”

 

Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient’s own T cells to fight cancer. Results from the pivotal phase II JULIET clinical trial served as the basis of the sBLA and MAA for Kymriah in adult patients with r/r DLCBL. Results from the pivotal phase II ELIANA study were submitted as part of the MAA for Kymriah in children and young adults with r/r B-cell ALL.

 

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