FDA Extends Review Period for Liso-Cel for Lymphoma Treatment
May 6th 2020The FDA has added 3 months to the review period for a biologics license application (BLA) for lisocabtagene maraleucel (liso-cel) for the treatment of adult patients with relapsed/refractory large B-cell lymphoma (LBCL) after at least 2 prior therapies. The extension will allow the agency to review additional data provided by Bristol Myers Squibb, the manufacturer of the anti-CD19 CAR T-cell therapy.
FDA Grants Priority Review to CC-486 for the Treatment of Acute Myeloid Leukemia
May 1st 2020The FDA granted priority review to a new drug application for CC-486 for the maintenance treatment of adult patients with acute myeloid leukemia based on efficacy and safety results from the pivotal phase III QUAZAR AML-001 study.
FDA Accepts Niraparib Application for Frontline Maintenance Ovarian Cancer Treatment
February 25th 2020The 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 Selinexor for DLBCL Treatment
February 21st 2020The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for selinexor (Xpovio) as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, who have received ≥2 prior therapies.
FDA Grants Priority Review to KTE-X19 for Treatment of Mantle Cell Lymphoma
February 11th 2020The 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 GIST
February 8th 2020The 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.