Incyte pulls FDA filing for cancer drug approval over confirmatory study, following Gilead out of the exit

Incyte pulls FDA filing for cancer drug approval over confirmatory study, following Gilead out of the exit

Source: 
Fierce Biotech
snippet: 

The follicular lymphoma market is thinning out fast. Days after Gilead Sciences pulled an accelerated approval for Zydelig in the indication, Incyte has withdrawn a submission for approval of its rival PI3K inhibitor in response to talks with the FDA about confirmatory studies.

Incyte filed for FDA approval of its PI3Kδ inhibitor parsaclisib in the treatment of relapsed or refractory follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma last year on the strength of phase 2 data. The filing positioned Incyte to win accelerated approvals in the indications this year and then perform confirmatory phase 3 studies to validate the signs of efficacy seen in the earlier trials.