AstraZeneca and Merck Receives European Commission Approval For Expanded Use In Breast Cancer Therapy

The European Commission (EC) has approved AstraZeneca AZN and Merck’s MRK LYNPARZA as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations (gBRCAm).

This regulatory approval was supported by the results from the Phase 3 OlympiA trial.

LYNPARZA has demonstrated a statistically significant and clinically meaningful improvement in over all survival (OS), 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

Earlier, The European Medicine Agency's Committee for Medicinal Products for Human Use has announced positive opinion on LYNPARZA and recommended for regulatory approval.

Dave Fredrickson, Executive vice president, AstraZeneca, said, "With this approval, LYNPARZAis 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."

Dr. Eliav Barr, Senior vice president, Merck Research Laboratories, stated, "Today's approval offers patients with germline BRCA-mutated, HER2-negative early-stage breast cancer a new, much-needed treatment option. LYNPARZAas 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."

LYNPARZA was approved in the United States for the adjuvant treatment of patients with gBRCAm, HER2-negative high-risk early breast cancer based on the OlympiA trial.

Price Action : Merck share are trading down at $87.30 on Thursday at the time of publication.