A new precision medicine combination offers hope for faster-progressing prostate cancer in male patients.
Thanks to pharma powerhouse Johnson & Johnson that has announced that the US FDA has approved the supplemental New Drug Application (NDA) for AKEEGA (niraparib and abiraterone acetate dual-action tablet) plus prednisone to treat patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC).
Patients with BRCA mutations often face aggressive disease and poor prognosis, representing a critical unmet need previously unaddressed.
“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 follows positive results from AMPLITUDE, a global, randomized, double-blind Phase 3 trial.
In patients with BRCA2-mutated mCSPC, AKEEGA plus prednisone and androgen deprivation therapy (ADT) cut the risk of radiographic progression or death by 54 percent compared to the current standard of care. The combination also prolonged time to symptomatic progression by 59 percent.
“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, US 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.”
