Novartis’ CAR T therapy Kymriah scores accelerated approval in both Europe and US

pharmafile | January 17, 2018 | News story | Research and Development, Sales and Marketing CAR T, CAR-T, EMA, Europe, FDA, Kymriah, Novartis, US, pharma 

Following up last year’s ground-breaking news that CAR T therapy Kymriah had become the first such treatment to be approved for the FDA – authorised for use in children and young adults with r/r B-cell acute lymphoblastic leukaemia (ALL) – Novartis has revealed that its proposed label expansion has been accepted under accelerated regulatory pathways on both sides of the Atlantic.

The US FDA has confirmed that it will be examining Kymriah under priority review for the treatment of relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) in adult patients, while the EMA has granted accelerated assessment to the therapy in children and young adults will ALL.  

This means that Novartis’ treatment will see a decision made four months earlier in the US, potentially as early as July, while it could see approval slightly earlier in Europe, while a decision made in June, two months earlier than through the usual pathway.

“The Priority Review designation and accelerated assessment signal that the FDA and EMA have recognised the potential of Kymriah to provide a much-needed therapeutic option for these patients,” said Novartis Oncology Global Drug Development Head, Samit Hirawat. “We are now focused on working with these regulatory agencies to bring this potentially transformative therapy to more patients.”

In addition to its novel function as a CAR T therapy in its treatment of cancer, Kymriah also made the headlines because of its tremendously high price tag, coming in at $475,000 per administration. Critics however noted that this actually came in below estimates, and was judged cost-effective by the non-profit organisation the Institute for Clinical and Economic Review. Novartis expects the treatment to eventually breach $1 billion in annual sales.

Matt Fellows

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