Today, Merck and AstraZeneca announced that the European Medicines Agency (or EMA) approved Lynparza tablets (300 mg twice daily) as a maintenance therapy for platinum-sensitive relapsed ovarian, fallopian tube, or primary peritoneal cancer.
Lynparza is a PARP inhibitor presently approved for the following indications:
- as a maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, in patients who are in complete or partial response to the platinum-containing chemotherapy.
- as a treatment for deleterious germline BRCA mutated advanced ovarian cancer in patients who have undergone at least three prior lines of chemotherapy
- as a treatment for deleterious germline BRCA mutated HER2-negative metastatic breast cancer in patients previously treated with chemotherapy
The approval was based on the two studies, SOLO-2 and Study 19, both of which show the reduced risk of disease progression and death with Lynparza for patients with platinum-sensitive relapsed ovarian cancer compared to placebo.
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