Astellas Pharma and Pfizer announced the FDA approved a supplemental New Drug Application (sNDA) for Xtandi (enzalutamide), following FDA Priority Review designation, based on results from the Phase 3 Prosper trial. The FDA action broadens the indication for Xtandi to men with castration-resistant prostate cancer (CRPC), now including men with non-metastatic CRPC. This approval makes Xtandi…
Prostate Cancer Study Shows Xtandi Significantly Cuts Metastasis Risk
Phase 3 PROSPER trial shows Xtandi (enzalutamide) significantly reduced the risk of metastasis or death by 71 percent in men with non-metastatic castration-resistant prostate cancer. Astellas Pharma Inc. and Pfizer Inc. announced results from the Phase 3 PROSPER trial in patients with non-metastatic (M0) castration-resistant prostate cancer (CRPC). The results show that the use of Xtandi…
FDA Fast Tracks Peanut Allergy Hypersensitivity Vaccine
Astellas announces FDA Fast Track designation for ASP0892, DNA vaccine for mitigation of severe hypersensitivity reactions due to peanut allergy. Astellas Pharma Inc. and Immunomic Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the drug candidate ASP0892 for the mitigation of severe hypersensitivity reactions due to peanut…