Johnson & Johnson (JNJ) announced on Friday that an expert panel of the EU drug regulator, the European Medicines Agency (EMA), endorsed an additional indication for its prostate cancer therapy Akeega, marketed with GSK (GSK).
The company said that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the use of Akeega as a combination therapy for metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations.
The dual-action tablet is already available in the EU for patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) for whom chemotherapy is not indicated.
The decision, supported by data from J&J’s (JNJ) Phase 3 AMPLITUDE study, which reached the primary endpoint of radiographic progression-free survival, will next be reviewed by the European Commission (EC) before a final decision on marketing authorization.
