FDA Accepts Niraparib Application for Frontline Maintenance Ovarian Cancer TreatmentFebruary 25th 2020
The FDA has accepted a supplemental New Drug Application (sNDA) for niraparib (Zejula) for use as a frontline maintenance treatment for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status.
FDA Grants Priority Review to KTE-X19 for Treatment of Mantle Cell LymphomaFebruary 11th 2020
The biologic license application is supported by data from the phase II ZUMA-2 trial, which is currently assessing the CAR T-cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
FDA Extends Review Period for Avapritinib to Treat GISTFebruary 8th 2020
The FDA has extended the Prescription Drug User Fee Act deadline for a new drug application (NDA) for avapritinib (Ayvakit) as a treatment for adult patients with fourth-line gastrointestinal stromal tumor (GIST). The deadline, which was initially February 14, 2020, has been extended by 3 months to May 14, 2020, according to BluePrint Medicines, the developer of avapritinib.