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.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 48,100+ biopharma pros who read Endpoints News by email every day.Free Subscription