Pfizer Inc. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted positive opinions recommending that two Pfizer hematology medicines be granted marketing authorizations in the European Union.
AstraZeneca and Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending a marketing authorization of Lynparza (olaparib) tablets (300 mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy.
Janssen-Cilag International NV announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended broadening the existing marketing authorization for Zytiga (abiraterone acetate) plus prednisone/prednisolone to include an earlier stage of prostate cancer than its current indications.
