FDA approves Pfizer's Talzenna for breast cancer alongside tool to identify eligible patients

The decision was based on study data derived from 431 participants with a known deleterious or suspected deleterious gBRCA mutation who had previously not received more than three prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease. Additionally, it was required that participants had previously received anthracycline and/or a taxane (unless contraindicated) treatment in the neoadjuvant, adjuvant, and/or metastatic treatment setting.

The data showed that median progression-free survival stood at 8.6 months for Talzenna and 5.6 months for chemotherapy.

Alongside the approval, the FDA also approved Myriad Genetics’ BRACAnalysis CDx test, a tool to identify suspected or confirmed deleterious gBRCAm breast cancer patients who are eligible for Pfizer’s newly approved drug.

"Myriad’s BRACAnalysis CDx test was shown in the EMBRACA trial to accurately identify certain patients with a germline BRCA-mutation who may benefit from Talzenna," explained Dr Johnathan Lancaster, Chief Medical Officer of Myriad Genetics.  "It is important for patients to know their BRACAnalysis CDx results so they can fully understand their treatment options."

Lloyd Sanders, president, Myriad’s President, added: "We congratulate Pfizer on obtaining FDA approval of Talzenna for certain patients living with metastatic breast cancer, and we are excited to expand the use of BRACAnalysis CDx as the companion diagnostic test. We estimate there are more than 60,000 patients diagnosed with or who progress to metastatic breast cancer in the United States every year who qualify for a BRACAnalysis CDx test."

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