Lynparza is said to be the first and only FDA approved adjuvant therapy for patients with gBRCAm, HER2-negative high-risk early breast cancer
AstraZeneca, MSD’s Lynparza approved in US. (Credit: jhenning from Pixabay)
AstraZeneca and Merck (called MSD outside of the US and Canada) have received the US Food and Drug Administration (FDA) approval for Lynparza (olaparib) to treat a type of early breast cancer.
The drug was indicated for the adjuvant treatment of germline BRCA-mutated (gBRCAm) HER2-negative early breast cancer in patients who were previously treated before or after surgery.
The patients eligible for receiving the treatment will be selected based on an FDA-approved companion diagnostic (CDx) test for Lynparza.
Lynparza is an advanced PARP inhibitor and the first targeted treatment designed to inhibit the DNA damage response (DDR) in cells or certain tumour cells.
The drug targets cells harbouring a deficiency in homologous recombination repair (HRR), such mutations in BRCA1 and/or BRCA2, the human genes that repair damaged DNA.
It was previously approved in the US, EU, Japan and several other countries worldwide, in this indication, including patients with locally advanced breast cancer.
AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “This important approval gives early-stage breast cancer patients in the US with a germline BRCA mutation a new targeted therapy option in the adjuvant setting starting today.
“Lynparza reduces the risk of disease recurrence in these high-risk patients and now new data confirm it also significantly extends patients’ lives versus placebo.
“These data underline the importance of germline BRCA testing as soon as possible after diagnosis to identify patients that may be eligible for Lynparza.”
The FDA approval was based on results from the Phase 3 OlympiA trial that assessed the efficacy and safety of Lynparza compared to placebo.
It was led by the Breast International Group, in partnership with the Frontier Science & Technology Research Foundation, NRG Oncology, the US National Cancer Institute, AstraZeneca and MSD.
Invasive disease-free survival (iDFS), defined as the time from randomisation to date of first locoregional or distant recurrence or new cancer or death, is the primary endpoint of the trial.
In the study, Lynparza has met the primary endpoint, showing a statistically significant and clinically meaningful improvement in iDFS.
The treatment has reduced the risk of invasive breast cancer recurrences, second cancers or death, by 42% compared to placebo.
In addition, updated results from the OlympiA trial showed statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival (OS).
MSD Research Laboratories senior vice president and global clinical development head, chief medical officer Roy Baynes said: “For patients with germline BRCA-mutated, HER2-negative high-risk early breast cancer, who often present with more aggressive disease, today’s approval is an important step forward.
“Compared to placebo, Lynparza as adjuvant treatment offers these patients the potential to live longer without their cancer recurring. We thank the patients, caregivers and healthcare providers for their participation in the OlympiA trial.”