JNJ - J&J seeks approval of Zytiga/Zejula combination for prostate cancer to EMA

Johnson and Johnson's (NYSE:JNJ) Janssen unit has submitted a marketing authorization application to the European Medicines Agency (EMA) seeking approval of a combination of Zytiga (abiraterone acetate) and Zejula (niraparib) for prostate cancer. The approval Janssen is seeking is for the combination plus prednisolone for patients with prostate cancer who have progressed to metastatic castration-resistant prostate cancer (mCRPC) and are positive for homologous recombination repair (HRR)+ gene alterations. The application is supported by data from the phase 3 MAGNITUDE study that showed a statistically significant improvement in radiographic progression-free survival in those receiving the combination compared to those on placebo or Zytiga and prednisolone. In February, an EMA advisory panel issued a positive opinion on Myovant Sciences' (MYOV) Orgovyx (relugolix) for advanced hormone-sensitive prostate cancer.

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J&J seeks approval of Zytiga/Zejula combination for prostate cancer to EMA