FDA clears Pfizer PARP drug, Myriad companion test for breast cancer

Dive Brief:

FDA approved Pfizer’s poly ADP ribose polymerase (PARP) inhibitor Talzenna (talazoparib) in conjunction with Myriad Genetics’ companion diagnostic for patients with HER2-negative, locally advanced or metastatic breast cancer who have an inherited BRCA mutation.
Patients must be selected for treatment based on Myriad’s BRACAnalysis CDx test to identify breast cancer patients eligible for talazoparib.
The approvals, granted following a priority review, were based on results from the Embraca trial that compared Talzenna to chemotherapy chosen by the physician in 431 patients with BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.

Dive Insight:

Talzenna is the second PARP inhibitor FDA has approved for the treatment of breast cancer. The drugs work by inducing cancer cell death by blocking a DNA repair mechanism.

In January, FDA granted the first, AstraZeneca’s Lynparza (olaparib), an expanded use to treat patients with metastatic breast cancer who have a BRCA gene mutation. Myriad’s test is also required to select patients eligible for Lynparza.

Breast cancer is the most common form of cancer in the United States. About 20% to 25% of patients with hereditary breast cancers and 5% to 10% of patients with any type of breast cancer have a BRCA mutation.

In the Embraca study of Talzenna for breast cancer, all patients were required to have a known deleterious or suspected deleterious BRCA mutation and received no more than three prior chemotherapy regimens.

Myriad said that more than 60,000 U.S. patients who are diagnosed with, or progress to, metastatic breast cancer each year likely qualify for a its test.

“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,” Johnathan Lancaster, chief medical officer of Myriad Genetics, said in a press release. “It is important for patients to know their BRACAnalysis CDx results so they can fully understand their treatment options.”

Pfizer picked up Talzenna in 2016 through its $14 billion acquisition of Medivation. Other PARP drug developers include Tesaro, which makes Zejula (niraparib), and Clovis Oncology, which makes Rubraca (rucaparib).