AZ and MSD’s Lynparza becomes first PARP inhibitor approved in US for metastatic breast cancer
pharmafile | January 15, 2018 | News story | Sales and Marketing | AstraZeneca, Cancer, FDA, MSD, breast cancer, lynparza, pharma
The FDA has announced that it has awarded marketing authorisation in the US to Lynparza (olaparib), a poly ADP-ribose polymerase (PARP) inhibitor developed by AstraZeneca and MSD as part of a partnership agreed in July 2017.
The therapy is approved for the treatment of deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer in adult patients who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.
As part of the authorisation, patients with hormone receptor positive (HR+) breast cancer who are to be administered with Lynparza should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.
The FDA’s decision was based on Phase 3 trial data which demonstrated that Lynparza was able to significantly improve progression-free survival compared to chemotherapy (capecitabine, eribulin or vinorelbine) and reduced risk of disease progression or death by 42%. The treatment also generated an objective response rate of 52% in patients with measurable disease, twice that of chemotherapy, and a confirmed complete response rate of 7.8%, compared to 1.5%.
“This new approval for Lynparza makes it the first and only PARP inhibitor approved in metastatic breast cancer, and the only PARP inhibitor approved beyond ovarian cancer,” commented Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca. “This is significant for breast cancer patients, as the identification of BRCA status, in addition to hormone receptor and HER2 status, becomes a potentially critical step in the management of their disease.”
Lynparza is now approved in three separate indications in the US, giving it the broadest clinical development programme of any PARP inhibitor.
Susan M Domchek, Executive Director of the Basser Center for BRCA at the Abramson Cancer Center of the University of Pennsylvania, added: “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. 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.”
Matt Fellows
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