The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency (EMA), has recommended the approval of Lynparza (olaparib) tablets for the treatment of advanced breast cancer patients whose tumor is HER2-negative and positive for BRCA mutations.
The recommendation is for patients already treated with chemotherapy — anthracycline and a taxane — unless they were not suitable for such treatments. Also, patients with hormone receptor (HR)-positive cancer should have received or been considered unsuitable for hormone therapy.
The European Commission will now review CHMP’s opinion before making a decision.
“Despite progress in treating patients with advanced breast cancer, there remains a significant unmet need for new treatment options,” Dave Fredrickson, executive vice president of oncology at AstraZeneca, said in a press release. “If approved, Lynparza will provide these patients with both a targeted and oral chemotherapy-free option.”
Lynparza, developed by AstraZeneca and Merck (known as MSD outside the U.S. and Canada), is a PARP inhibitor that blocks the DNA repair process. The PARP enzyme is particularly relevant for DNA repair in people with BRCA mutations, and blocking it prevents the survival of tumors.
Lynparza is currently available for the maintenance treatment of ovarian cancer patients, and is already approved in the U.S. and Japan for BRCA-mutated, HER2-negative metastatic breast cancer patients who received prior chemotherapy.
These breast cancer approvals, like the submission to the European regulatory agency, were all supported by results from the ongoing OlympiAD Phase 3 trial (NCT02000622), where Lynparza decreased the risk of disease progression or death by 42% compared to chemotherapy.
OlympiAD included 302 patients with HER2-negative locally advanced or metastatic breast cancer randomly assigned Lynparza or physician’s choice chemotherapy — Xeloda (capecitabine), Navelbine (vinorelbine), or Halaven (eribulin).
Its main goal was to determine whether treatment with 300 mg Lynparza tablets twice daily could delay disease progression or death. Secondary measures included time to disease progression or death after a subsequent treatment, overall survival, objective response rate, and quality of life assessments.
Investigators found that patients on Lynparza lived a median of seven months before their disease progressed, compared to 4.2 months for those given chemotherapy — a 42% reduction in the risk of disease progression or death.
Also, more patients responded to Lynparza (60%) compared to chemotherapy (29%). Complete responses were also more frequent in the Lynparza group — 9% versus 1.5%.
Lynparza also reduced the risk of death or disease progression after a subsequent therapy by 43%, but had no impact on patients’ overall survival.
“The positive opinion from CHMP for Lynparza in this patient population is an important milestone,” said Roy Baynes, MD, PhD, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
“This decision brings us one step closer to offering a new treatment option to patients with advanced breast cancer and further underscores the critical need to identify patients’ BRCA status, in addition to hormone receptor and HER2 expression status, as part of the management of this disease,” he said.
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