Johnson & Johnson announces FDA approved sNDA for AKEEGA plus prednisone

Johnson & Johnson announced the U.S. Food and Drug Administration, FDA, approved the supplemental New Drug Application, sNDA, for AKEEGA plus prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer, mCSPC. Patients with BRCA mutations often have more aggressive forms of prostate cancer leading to poor prognosis, representing a significant unmet need not addressed by previously available therapies. “There remains an urgent need for novel therapies for patients with BRCA2-mutated mCSPC, who face significantly faster disease progression and often shorter survival compared to those without the mutation,” said Bradley McGregor, M.D., Director of Clinical Research for the Lank Center of Genitourinary Oncology at Dana-Farber Cancer Institute. “AMPLITUDE is the first study to show that this precision medicine combination of a PARP inhibitor with an androgen receptor pathway inhibitor delays both radiographic and symptomatic disease progression.”