Johnson & Johnson seeks EMA approval to accelerate prostate cancer treatment
Ella Day | July 4, 2025 | News story | Medical Communications, Research and Development | European Medicines Agency, Genito-Urinary system, Johnson & Johnson, Oncology, clinical trial, prostate cancer
Johnson & Johnson has submitted an application to the European Medicines Agency for an indication extension of Akeega (niraparib and abiraterone acetate dual action tablet), aiming to treat adult patients with metastatic hormone-sensitive prostate cancer who carry homologous recombination repair (HRR) gene alterations.
The submission builds on positive results from the company’s phase 3 AMPLITUDE trial, which investigated niraparib in combination with abiraterone acetate with prednisone or prednisolone versus abiraterone acetate plus prednisone alone – the current standard of care. It demonstrated that the niraparib-based regimen significantly delayed cancer progression and the worsening of symptoms, particularly in the subgroup of patients with HRR gene mutations.
“Individuals with HRR gene alterations often face limited treatment options, faster onset of symptoms and poorer outcomes,” said Henar Hevia, senior director, Europe, Middle East and Africa therapy area head of oncology at Johnson & Johnson. “This submission marks a step forward in providing a treatment tailored to the biology of their disease.”
The AMPLITUDE trial showed statistically significant improvements in radiographic progression-free survival and time to symptomatic progression, with an early trend toward overall survival benefit. The safety profile aligned with previous studies in metastatic castration-resistant prostate cancer.
If approved, Akeega would become the first combination of a poly (ADP-ribose) polymerase inhibitor and androgen receptor pathway inhibitor authorised for this earlier stage of prostate cancer, expanding precision medicine options for this high-risk group.
Ella Day
4/7/25
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