Lynparza Receives First-in-Class Approval for Early Breast Cancer

March 11, 2022

Lynparza® (olaparib – AstraZeneca and Merck) is now FDA approved as an adjuvant treatment for patients diagnosed with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative high-risk early breast cancer who have already received chemotherapy either before or after surgery.

  • Lynparza is the first drug in its class (PARP inhibitors) to receive FDA approval for treatment of early breast cancer.
  • The FDA first approved Lynparza in 2014 to treat ovarian The drug has since gained indications to treat pancreatic cancer, prostate cancer, and metastatic breast cancer.
  • Recommended dosing for early breast cancer is 300mg taken twice daily for a total of one year, or until disease recurrence or unacceptable toxicity occur.
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