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AstraZeneca PLC said on Thursday that Lynparza, which was co-developed with Merck & Co Inc, has received approval in the EU for early high-risk breast cancer, triggering a milestone payment from its collaborator.
The Cambridge, England-based pharmaceutical company said the PARP inhibitor treatment Lynparza, generically olaparib, has been approved as a monotherapy or in combination with endocrine therapy for adult breast cancer patients.
The decision from the European Commission is based on the results from the OlympiA phase III trial, which was published last June.
The approval covers adults with germline BRCA1/2 mutations with human epidermal growth factor receptor 2-negative high-risk early breast cancer, who have previously been treated with neoadjuvant or adjuvant chemotherapy.
AstraZeneca will receive a $75 million regulatory milestone payment from Merck, which it will report as collaboration revenue in the third quarter of 2022.
‘With this approval, Lynparza is now the first and only PARP inhibitor available for patients with germline BRCA-mutated HER2-negative early breast cancer in Europe. We can now bring the benefits of Lynparza to this earlier setting to help reduce the risk of life-threatening recurrence,’ said Astra's Oncology Executive Vice President Dave Frederickson.
The approval follows news in mid-July from Merck that a Lynparza phase III trial for unresectable or colorectal cancer was stopped due to futility.
Astra shares were up 0.5% to 10,718.00 pence each in London on Thursday morning. Merck was up 0.3% in pre-market trading in New York at $87.62.
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