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Lynparza has been approved in Great Britain as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.
AstraZeneca announced on Sept. 6, 2022 that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Lynparza (Olaparib) in Great Britain for the adjuvant treatment for adult patients with germline BRCA-mutated HER2-negative high-risk early breast cancer. The treatment may be used as monotherapy or in combination with endocrine therapy and is for use in patients who have been previously treated with neoadjuvant or adjuvant chemotherapy.
According to a company press release, an estimated 2.3 million patients are diagnosed with breast cancer each year, making it the most diagnosed cancer worldwide. Almost 56,000 people are diagnosed with breast cancer per year in the United Kingdom, and roughly 90% of all breast cancer patients are diagnosed in an early stage of disease. BRCA mutations are found in approximately 5% of patients. One in three women may still experience a recurrence, and if the cancer recurs, it is incurable.
The decision from the MHRA was based on results from the OlympiA Phase III trial. In the primary endpoint of the trial, there was a statistically significant and clinically meaningful improvement in three-year invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrences, second primary invasive cancers, or death.
“Today’s approval marks a new era of care in the UK for patients with an inherited form of breast cancer,” said Andrew Tutt, chair of the OlympiA Phase III trial and professor of oncology at The Institute of Cancer Research, London and King’s College London, in the press release. “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 a targeted treatment option that exploits the specific biology of this inherited type of breast cancer and was shown to improve survival and help prevent cancer recurrence. I am hopeful it will become a new standard of care.”