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 combination use of Darzalex with bortezomib, thalidomide, and dexamethasone was approved for transplant-eligible patients with multiple myeloma.
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 simulataneously approved in Australia and Canada and was the first such action under a new international collaboration.
The FDA approved selinexor in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma.
The FDA approved daratumumab in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The FDA approved pembrolizumab as a treatment option for patients with metastatic small-cell lung cancer.
The FDA approved pembrolizumab for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma.