Third Indication Approved to Receive Olaparib


The U.S. Food and Drug Administration has approved a third indication for olaparib tablets (Lynparza).

The U.S. Food and Drug Administration has approved a new indication for olaparib tablets (Lynparza).

The PARP inhibitor is now available to patients with deleterious or suspected germline BRCA-mutated (bBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. In August, it was granted approval as a maintenance treatment for adult patients experiencing recurrent epithelial ovarian fallopian tube, or primary peritoneal cancer, who are in response (either complete or partial) to platinum-based chemotherapy.

The BRCA1 and BRCA2 genes play a critical role maintaining the genetic stability of cells, and produce proteins responsible for repairing damaged DNA. When either of these genes is mutated, such that its protein product either does not function appropriately or is not made at all, DNA damage may not be repaired correctly, and cells can become unstable. This can lead to the likelihood that the cells develop additional genetic alterations, potentially resulting in cancer.

The most recent indication approved for the drug is the third, making it the only PARP inhibitor regulated in metastatic breast cancer, and the only PARP inhibitor approved in more than one tumor type. Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit, AstraZeneca, recognizes the importance of the news: “This is significant for breast cancer patients, as the identification of BRCA status, in addition to hormone receptor and HER2 status, becomes a potentially critical step in the management of their disease.”

The approval comes after successful results from the randomized, open-label, Phase 3 OlympiAD trial, which compared olaparib to physician’s choice of chemotherapy, either capecitabine, eribulin, or vinorelbine. When evaluated against standard of care chemotherapy, the drug exhibited the ability to reduce the risk of disease progression or death by 42%.

The most common adverse reactions of patients who received olaparib included: nausea, anemia, fatigue, vomiting, neutropenia, respiratory tract infection, leukopenia, diarrhea, and headache.

“We know there are limited treatment options for patients with metastatic breast cancer,” said ue Friedman, Executive Director and founder of the nonprofit organization, Facing Our Risk of Cancer Empowered (FORCE). “For the portion of the 155,000 women in the US living with metastatic breast cancer who have an inherited BRCA mutation, today’s news is encouraging. By undergoing genetic testing for BRCA mutations, we can gain critical information that will inform personalized treatment options specifically for women with this mutation.”

For more from the FDA, including applications, designations and approvals, follow Rare Disease Report on Facebook and Twitter.

Related Videos
Signs and Symptoms of Connective Tissue Disease
How Gene and Cell Therapy Is Developing in Dermatology
Joyce Teng, MD, PhD, discusses how therapeutic advances in fields like epidermolysis bullosa should progress treatment discourse in other rare dermatoses.
The Prospect of Pz-cel in RDEB Treatment, with Peter Marinkovich, MD
Comparing New Therapies for Dystrophic Epidermolysis Bullosa
Reviewing 2023 with FDA Commissioner Robert M. Califf, MD
Dunia Hatabah, MD | Image Credit: HCPLive
Ricky Safer: What Clinicians Need to Know About PSC
Ryan T. Fischer, MD: Long-Term Odevixibat Benefit for Alagille Syndrome
Saeed Mohammad, MD: IBAT Inhibitors for Cholestatic Disease
© 2024 MJH Life Sciences

All rights reserved.