Lynparza (olaparib) was approved by the European Commission as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations (gBRCAm), who have HER2-negative, high-risk, early-stage breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.
The drug is sponsored by AstraZeneca and Merck.
This approval was based on results from the phase III OlympiA trial and the recommendation for approval by the European Medicine Agency’s Committee for Medicinal Products for Human Use.
The results were published in The New England Journal of Medicine in June 2021.
In OlympiA, Lynparza demonstrated an improvement in invasive disease-free survival, reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42% versus placebo.
Lynparza also demonstrated an improvement in overall survival, reducing the risk of death by 32% versus placebo.
The safety and tolerability profile of Lynparza in this trial was in line with that observed in prior clinical trials. Approximately 10% of patients who received Lynparza discontinued treatment due to an AR.
“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,” Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said in a statement.
In March 2022, Lynparza was approved in the U.S. for the adjuvant treatment of patients with gBRCAm, HER2-negative high-risk early breast cancer based on results from the OlympiA trial. Lynparza is also approved in Japan and several other countries.
The OlympiA trial is led by the Breast International Group in partnership with the Frontier Science & Technology Research Foundation, NRG Oncology, the U.S. National Cancer Institute, AstraZeneca and Merck.
Lynparza is a poly adenosine diphosphate-ribose polymerase inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells.
Inhibition of PARP with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death.
Lynparza is being tested in a range of tumor types with defects and dependencies in the DDR.
Complete prescribing information can be found here. The medication guide can be found here.
