Johnson & Johnson says the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for AKEEGA (niraparib and abiraterone acetate dual-action tablet) 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, 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.”
The approval is based on positive results from AMPLITUDE (NCT04497844), a randomized, double-blind, placebo-controlled, international phase 3 clinical study. In patients with BRCA2-mutated mCSPC, treatment with AKEEGA plus prednisone and androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression or death by 54% compared to placebo/abiraterone acetate plus prednisone and ADT, which is the current standard of care. AKEEGA plus prednisone and ADT also significantly prolonged the time to symptomatic progression by 59%.
The observed safety profile of the combination of AKEEGA plus prednisone was consistent with the known safety profile of each FDA-approved monotherapy. In the AMPLITUDE clinical study, the most common adverse reactions (≥20%) including laboratory abnormalities, were decreased haemoglobin, decreased lymphocytes, musculoskeletal pain, fatigue, decreased platelets, increased alkaline phosphatase, constipation, hypertension, nausea, decreased neutrophils, increased creatinine, increased potassium, decreased potassium, decreased aspartate aminotransferase, fluid retention/oedema, increased bilirubin, respiratory tract infection and arrhythmia.
“This expanded indication for AKEEGA reflects our commitment to push the boundaries of science and deliver more personalized, effective treatment options across the prostate cancer continuum,” said Mahadi Baig, vice president, head of Solid Tumors, U.S. Medical Affairs, Johnson & Johnson Innovative Medicine.
“Supported by strong clinical data, AKEEGA is now the first and only PARP-based precision medicine combination treatment in BRCA2-mutated mCSPC, offering patients hope for more time with a new way to potentially delay their cancer from progressing.”
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