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FDA approves AstraZeneca’s Lynparza

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WILMINGTON – The U. S Food and Drug Administration has granted approval to Lynparza, AstraZeneca and Merck’s PARP inhibitor for maintenance therapy for some ovarian cancer patients, according to the companies. PARP is a family of proteins involved in cellular processes involving DNA repair and programmed cell death.

Lynparza has been approved as a maintenance treatment for adult patients with several recurrent cancers. Lyparza may also be used in tablet form in a twice-daily regimen now.

“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,” said Dr. Sean Bohen, executive vice president of global medicines development for AstraZeneca. “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.”

Dr. Richard Penson, clinical director of medical gynecologic oncology at Massachusetts General Hospital Cancer Center, the primary investigator in the trial, said the approval demonstrates the treatment is an effective option for certain ovarian cancer patients. “We welcome this news in the ovarian cancer community as more options are important to help us ensure that patients can find a treatment that is right for them,” Penson said.

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