Janssen-Cilag, a subsidiary of Johnson & Johnson, has submitted an application to the European Medicines Agency seeking expanded approval for AKEEGA, a combination therapy of niraparib and abiraterone acetate, for treating adults with metastatic hormone-sensitive prostate cancer who have specific genetic alterations.
Targeting Patients with Genetic Alterations
The new application focuses on patients with homologous recombination repair gene alterations, a genetic profile that affects over 20% of mHSPC patients. These alterations include changes in BRCA1/2 genes, which are crucial for DNA repair mechanisms. According to the company's submission, patients with these genetic changes often experience worse outcomes and have limited treatment options compared to the broader mHSPC population.
Phase 3 AMPLITUDE Study Results
The regulatory submission is based on results from the Phase 3 AMPLITUDE study, which evaluated the combination of niraparib and abiraterone acetate with prednisone or prednisolone against the current standard treatment. The study demonstrated that the combination therapy significantly delayed cancer progression and the worsening of symptoms in this genetically defined patient population.
Addressing Unmet Medical Need
While treatments for metastatic hormone-sensitive prostate cancer have improved overall, the subset of patients with HRR gene alterations represents a significant unmet medical need. The genetic alterations affect the cells' ability to repair DNA damage, potentially making these cancers more susceptible to certain targeted therapies like PARP inhibitors, which niraparib represents.
Regulatory Strategy
The July 3 application represents Johnson & Johnson's strategy to expand AKEEGA's therapeutic reach beyond its current indications. The company is leveraging precision medicine approaches by targeting specific genetic biomarkers to identify patients most likely to benefit from the combination therapy.
