Stephen M. Hahn, MD, from The University of Texas MD Anderson Cancer Center, will take over as Commissioner of the FDA, voted on by the Senate on Thursday.
Niraparib was approved by the (FDA) for previously treated advanced ovarian, fallopian, or primary peritoneal cancers.
The agency is set to make a decision on the investigational antibody drug conjugate by the first quarter of 2020.
The agency granted breakthrough therapy designation to niraparib for the treatment of men with BRCA1/2-mutant positive metastatic castration-resistant prostate cancer.
The first-of-its-kind collaboration led to the approval of a combination therapy for patients with endometrial cancer.
Apalutamide was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer; the recent approval is for patients with metastatic castration-sensitive prostate cancer.
The combination was simultaneously approved in Australia and Canada and was the first such action under a new international collaboration.
The FDA has recently approved new dosage form and two new indications for the drug.
Erdafitinib is first targeted therapy for FGFR3 or FGFR2 genetic alteration.