Kymriah gets speedy reviews in US and EU as Novartis looks to swiftly expand CAR-T indications
Equipped with data to directly compete with Gilead’s $GILD CAR-T, Novartis has secured promises of quick reviews of Kymriah for a second indication in both the United States and Europe.
The Swiss drugmaker $NVS started the day with news that the FDA has granted priority review to Kymriah in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant. That’s something Yescarta goes after, and marks a new target for Kymriah after B-cell acute lymphoblastic leukemia.
Meanwhile, the EMA is giving accelerated assessment to Kymriah for both indications: children, young adults with r/r B-cell ALL and adults with r/r DLBCL who are ineligible for autologous stem cell transplant.
Priority review in the US cuts the decision time from 10 months to within 6 months; Europe’s accelerated review shortens the time frame from 210 to 150 days. And the FDA has been revving up even faster approvals for top programs like this.
As the CAR-T field turns hot, Kymriah — the first approved treatment in this class — is set to face off an ever growing group of strong contenders. Novartis expects Kymriah will eventually top $1 billion in annual sales. The priority review is a crucial step to realizing that blockbuster expectation.