FDA Approves Oral Breast Cancer Therapy Talazoparib

By Scott Glovsky on November 29th, 2018 in Insurance and Healthcare Denials

The FDA has approved the oral therapy Talazoparib, which is given to patients with a type of advanced breast cancer called BRCA-positive. The approval is based on results from a study that compared the results of Talazoparib against results from the Physician’s Choice chemotherapy drug in patients with advanced BRCA-gene germline breast cancer. The study found that Talazoparib provided a significant benefit to patients over standard chemotherapy.

Individuals with HER2-negative locally advanced or metastatic breast cancer and positive or suspected positive BRCA mutations are eligible to use Talazoparib. Participants must be selected for this therapy based on an FDA-approved diagnostic test.

This test, known as a BRACAnalysis CDx test, is the only approved test for identifying patients who are eligible for Talazoparib. This test is developed by Myriad Genetic Laboratories, Inc. and identifies mutated BRCA1 and BRCA 2 genes using in-vitro technology. The diagnostic technology uses a chemical agent to prevent blood clotting while studying the DNA present in blood cells.

“We are excited to support Pfizer’s clinical development program and help identify patients who are most likely to benefit from Talazoparib,” said Mark C. Capone, president and CEO of Myriad Genetics. “As the pioneers in companion diagnostics for PARP inhibitors, we are excited that more patients may benefit from these novel drugs in the future.”

To be eligible for enrollment in this medical program, patients potentially must have received no more than three prior cytotoxic chemotherapy regimens for locally advanced or metastatic breast cancer. Patients must also have received certain types of chemotherapy treatments – anthracycline and/or taxane – during the early, pre-surgery, and/or metastatic stages of therapy.

Any individual who has been denied this therapy and would like to appeal or wants to review their eligibility for this medical treatment should not hesitate to reach out to the attorneys at Glovsky Law Firm. Our knowledgeable attorneys could help you assess your legal options regarding this treatment or other cancer treatments.