Johnson & Johnson’s (NYSE:JNJ) Janssen unit announced Friday that a group of experts from the European Medicines Agency (EMA) recommended marketing authorization for its oral PARP inhibitor niraparib as a combination regimen for certain adults with prostate cancer.
With its latest decision, EMA’s Committee for Medicinal Products for Human Use (CHMP) recommends niraparib with abiraterone acetate as Akeega for adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations.
The recommendation is to use Akeega alongside prednisone or prednisolone as a dual action tablet (DAT) with AA for prostate cancer patients for whom chemotherapy is not indicated.
J&J (JNJ) has partnered with Tesaro, Inc. for niraparib, a treatment already indicated in Europe for various cancers, including ovarian, fallopian tube, or peritoneal cancer, as monotherapy as a second-line option. GSK (GSK), which acquired Tesaro in 2019, markets Akeega as Zejula.
Prostate cancer is the most prevalent cancer type among men in Europe. Those with mCRPC and BRCA mutations are more likely to develop aggressive diseases with poor outcomes and shorter survival.
CHMP’s decision will next be reviewed by the European Commission (EC), which will finalize the authorization.
Seeking Alpha contributor Mark Roussin reaffirmed his Buy rating on J&J (JNJ) last week, noting the defensive nature of healthcare amid macro uncertainty.