AstraZeneca, Merck get FDA OK for ovarian cancer drug

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AstraZeneca and Merck & Co., Inc. announced that the US Food and Drug Administration has granted approval for Lynparza (olaparib) for some  types of ovarian cancer.

Approvals were for:

  • New use of Lynparza as a maintenance treatment for recurrent, epithelial ovarian, fallopian tube or primary peritoneal adult cancer who are in response to platinum-based chemotherapy.
  • New use of Lynparza tablets (2 tablets twice daily) as opposed to capsules (8 capsules twice daily);
  • Lynparza tablets also now indicated (conversion from the current (accelerated approval) for the use in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy.

Sean Bohen, executive vice president, Global Medicines Development and chief medical officer, AstraZeneca, said: “Physicians have almost three years of clinical experience with Lynparza on the market and we are now pleased to bring this important medicine, in a new tablet formulation, to a broader group of women. Today’s approvals validate more than 10 years of dedicated research behind Lynparza, the world’s first PARP inhibitor, which now provides oncologists with the greater flexibility for use in terms of treatment settings. It builds on our recently-announced collaboration with Merck, which aims to further increase the number of treatment options available to patients.”

Roger M. Perlmutter, president of Merck Research Laboratories, said: “We congratulate AstraZeneca on the approval of these new indications and the new dosage form and schedule for Lynparza, an important therapeutic advance for many patients with ovarian cancer. This is a significant first regulatory event in our collaboration with AstraZeneca. We look forward to working with AstraZeneca in our global collaboration to bring this medicine with its new indications to patients.”

AstraZeneca has about 1,500 employees in Delaware.

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