FDA Accepts Kymriah for Supplemental Biologics License Application


The phase 2 Elara trial for the follicular lymphoma treatment met its primary endpoints, Novartis says.

The European Medicines Agency and the FDA have accepted Novartis’s type 2 variation and company supplemental biologics license application, respectively, for tisagenlecleucel (Kymriah) for individuals with relapsed or refractory (r/r) follicular lymphoma (FL) after 2 prior lines of treatment, according to company statement.

“This is an important milestone in our mission to bring Kymriah to adult patients with relapsed or refractory follicular lymphoma. Receiving orphan drug designation from the [European Commission (EC}] as well as priority review from the FDA underscores the unmet need and urgency for these patients,” Jeff Legos, executive vice president of global head of oncology and hematology development at Novartis, said in the statement. “With Kymriah demonstrating impressive results in the ELARA trial, we are hopeful that we can offer a unique and potentially definitive treatment that minimizes the burden.”

The FDA also granted priority review to the sBLA for tisagenlecleucel, and the EC previously granted orphan medicinal product designation to tisagenlecleucel.

The submissions are based on data from the phase 2 Elara trial to determine the efficacy and safety of tisagenlecleucel for adult individuals with r/r FL. The trial met its primary endpoints, and the safety profile showed no individuals experiencing grade 3 or higher cytokine release syndrome within the first 8 weeks following infusion.

Orphan drug designation is for medications that diagnose, prevent, or treat a chronically debilitating or life-threatening rare disease with prevalence in the European Union below 5 in 10,000 individuals.

Priority review is granted to therapies that have the potential to provide significant improvements in diagnosis, prevention, or treatment of serious conditions.

The findings were presented at the 2021 Annual American Society of Clinical Oncology Virtual Scientific Meeting.


Novartis receives priority review by US FDA and filing acceptance by EMA for Kymriah® to treat patients with relapsed or refractory follicular lymphoma. Novartis. News release. October 27, 2021. Accessed on October 27, 2021. https://www.novartis.com/news/media-releases/novartis-receives-priority-review-us-fda-and-filing-acceptance-ema-kymriah-treat-patients-relapsed-or-refractory-follicular-lymphoma

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