Novartis gets a speedy review for its CAR-T pioneer as FDA lines up a marketing decision
Novartis $NVS has pulled into the inside track at the FDA with its CAR-T CTL019, picking up a priority review from the agency that will land a marketing decision for relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia.
The pioneering application comes as we wait for Kite to make its move at the agency after being forced to wait for 6-month data on its rival CAR-T. Kite $KITE has promised to finish its rolling application by the end of Q1, now just days away. And a spokesperson for Kite tells me now that the biotech is on track to wrap the submission by Friday.
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