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Biotech Stocks Facing FDA Decision in April

Novartis
Novartis

Novartis' (NVS) supplemental Biologics License Application seeking approval of Kymriah 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) is under Priority Review by the FDA.

The supplemental Biologics License Application was submitted by the Company on October 31, 2017. Under Priority Review, the FDA will take action on an application within 6 months, and so the estimated timeline for the FDA decision on Kymriah’s new indication is estimated to be April 30, 2018.

Kymriah, a one-time treatment, was approved last August for the treatment of children and young adults up to 25 years of age suffering from a form of acute lymphoblastic leukemia that doesn't respond to standard treatment or has relapsed at least twice. It is the first chimeric antigen receptor T cell (CAR-T) therapy to be greenlighted by the FDA.

In the U.S, Kymriah costs $475,000 (list price).

NVS closed Tuesday’s (Mar.27) trading at $79.45, down 0.29%.