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.