OR WAIT null SECS
© 2023 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
The European Commission has approved AstraZeneca and Merck’s Lynparza (olaparib) as an adjuvant treatment for BRCA-mutated HER2-negative high-risk early breast cancer.
On Aug. 4, 2022, AstraZeneca and Merck, known as MSD outside the United States and Canada, announced that the European Commission (EC) approved Lynparza (olaparib) as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline breast cancer gene (BRCA)1/2 mutations (gBRCAm), who have human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer. The approval is for patients previously treated with neoadjuvant or adjuvant chemotherapy.
With this approval for Lynparza in the European Union, AstraZeneca is set to receive a $75 million regulatory milestone payment from Merck.
The EC’s approval was based on results from a Phase III trial (OlympiA) and a recommendation from the Committee for Medicinal Products for Human Use. In the trial, Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival, reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42% compared to placebo. The drug also demonstrated a statistically significant and clinically meaningful improvement in overall survival, reducing the risk of death by 32% compared to placebo.
“[This] approval marks a new era of care in Europe for patients with an inherited form of breast cancer. For patients with high-risk early-stage breast cancer, including those with germline BRCA mutations, recurrence rates remain unacceptably high, with more than one in four of these patients seeing their cancer return following surgery and systemic treatment. Olaparib is the first PARP [Poly(ADP-Ribose)Polymerase] inhibitor to demonstrate improved overall survival for high-risk early-stage breast cancer patients with germline BRCA mutations, and I am hopeful it will become a new standard of care,” said Andrew Tutt, global chair of the OlympiA Phase III trial and professor of Oncology at The Institute of Cancer Research, London, and King’s College London, in a company press release.
“Today’s approval offers patients with germline BRCA-mutated HER2-negative early-stage breast cancer a new, much-needed treatment option. Lynparza as adjuvant treatment can significantly reduce the risk of disease recurrence and death, reinforcing the importance of conducting germline BRCA testing as soon as possible after diagnosis,” said Eliav Barr, senior vice-president, head of Global Clinical Development and chief medical officer, Merck Research Laboratories, in the press release.
Lynparza was approved in March 2022 in the United States for treating gBRCAm, HER2-negative high-risk early breast cancer. The drug is also approved in the US, European Union, Japan, and many other countries for treating patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy.