AstraZeneca confirms new EU approval for 'Lynparza'
AstraZeneca and its partner Merck & Co announced on Wednesday that the European Commission has approved 'Lynparza' (olaparib) as a monotherapy for the treatment of adult patients with germline BRCA1 and 2-mutations (gBRCAm), and who have human epidermal growth factor receptor 2 (HER2)-negative locally-advanced or metastatic breast cancer.
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The FTSE 100 pharmaceuticals giant explained that under the licensed indication, patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless they were unsuitable for these treatments.
Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.
It said the approval was based on data from the randomised, open-label phase 3 OlympiAD trial, which tested Lynparza compared to physician's choice of chemotherapy - capecitabine, eribulin, or vinorelbine.
In the trial, Lynparza provided patients with a statistically-significant median progression-free survival improvement of 2.8 months.
Patients taking Lynparza experienced an objective response rate of 52%, which was double the rate for those in the chemotherapy arm.
AstraZeneca said it was the third indication for Lynparza in the EU, with the two companies said to be working together to deliver Lynparza as quickly as possible to more patients across multiple settings.
It said Lynparza had a “broad” clinical development programme, including the ongoing phase 3 OlympiA, which was testing Lynparza as an adjuvant treatment in patients with gBRCAm HER2-negative breast cancer.
“With this approval, Lynparza provides patients throughout the EU with a targeted and oral chemotherapy-free treatment option for a difficult-to-treat cancer,” said AstraZeneca’s executive vice-president of oncology Dave Fredrickson.
“It also reinforces the importance of testing for biomarkers including BRCA, hormone receptor and HER2 expression, helping physicians to make the most informed treatment decisions for patients.”
Roy Baynes, senior vice president and head of global clinical development, and chief medical officer at Merck’s MSD Research Laboratories, added that in the OlympiAD trial, which supported the approval, Lynparza demonstrated a “meaningful improvement” in progression-free survival compared to chemotherapy in patients with germline BRCA-mutated metastatic breast cancer.
“We look forward to making this new option available across the EU, where we hope it will improve outcomes for many patients,” Baynes said.