Johnson & Johnson has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended expanding the indication for AKEEGA, a dual action tablet containing niraparib and abiraterone acetate, for use with androgen deprivation therapy and prednisone or prednisolone in adult patients with metastatic hormone-sensitive prostate cancer who carry BRCA1 or BRCA2 mutations. This recommendation follows positive results from the Phase 3 AMPLITUDE study.
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The AMPLITUDE study evaluated 696 patients with HRR gene alterations and compared the niraparib and abiraterone acetate combination with standard therapy. In patients with BRCA mutations, the combination significantly delayed radiographic disease progression, with median progression-free survival not reached compared to 26 months for the control group, representing a 48 percent lower risk of progression or death. The regimen also extended time to symptomatic progression by 56 percent and showed an early trend toward improved overall survival.
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The safety profile of the combination was consistent with prior studies in advanced prostate cancer. Most adverse events were manageable and primarily included anemia and hypertension. Treatment discontinuation due to side effects remained low, highlighting the tolerability of the dual action tablet in this patient population.
Henar Hevia, Ph.D., Senior Director and EMEA Therapeutic Area Head for Oncology at Johnson & Johnson Innovative Medicine, noted that patients with BRCA1/2 mutations often experience faster disease progression and limited treatment options before developing castration-resistant prostate cancer. He emphasized that the niraparib and abiraterone combination offers a targeted therapy earlier in the metastatic pathway to address this urgent need.
Charles Drake, M.D., Ph.D., Vice President and Prostate Cancer and Immunotherapy Disease Area Leader at Johnson & Johnson Innovative Medicine, added that the study demonstrates the value of precision medicine in metastatic hormone-sensitive prostate cancer while complementing existing treatments such as apalutamide with ADT. AMPLITUDE is a global, randomized, double-blind, placebo-controlled trial conducted in 32 countries with radiographic progression-free survival as its primary endpoint.
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