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Marian Johns | Jan 17, 2018

FDA approves Lynparza as first PARP Inhibitor for treating metastatic breast cancer

Merck said Lynparza (olaparib), a targeted therapy co-developed with AstraZeneca, has become the first PARP inhibitor approved by the Food and Drug Administration for treating metastatic breast cancer. 

Lynparza is designed for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer and who have been previously treated with chemotherapy either in the neoadjuvant, adjuvant or metastatic setting, Merck said in a Jan 12 release.

“This new approval for Lynparza makes it the first and only PARP inhibitor approved in metastatic breast cancer, and the only PARP inhibitor approved outside of ovarian cancer," Dave Fredrickson, AstraZeneca business unit's executive vice president and head of oncology, said in the release.

According to the companies, an estimated 155,000 women in the U.S. will be living with metastatic breast cancer in 2018 and is anticipated to increase to 160,000 by 2020.

“Patients diagnosed with BRCA-related metastatic breast cancer are often younger than other breast cancer patients, and their disease is often much more aggressive and difficult to treat,” Dr. Susan Domchek, executive director of the Basser Center for BRCA at the Abramson Cancer Center of the University of Pennsylvania and national leader on the OlympiAD trials, said in the release. “While there is currently no cure for metastatic breast cancer, today’s approval offers a new, targeted option that may help to delay disease progression for these patients.”

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