Myriad Genetics will support the post-marketing regulatory development of Clovis Oncology‘s drug Rubraca (rucaparib) to treat women with BRCA-positive advanced ovarian cancer who have already received two or more chemotherapies.
The U.S. Food and Drug Administration (FDA) granted Rubraca accelerated approval in December 2016. But the Clovis genetic test approved with the drug does not distinguish between inherited and acquired BRCA mutations. That led the FDA to request that Rubraca be included in the indications for Myriad’s diagnostic test, BRACAnalysis CDx. This is the only FDA-approved test that detects inherited BRCA mutations. Knowledge of that status is important in providing women appropriate counseling.
“BRACAnalysis CDx is the only germline companion diagnostic test approved by the FDA to identify patients with BRCA1/2 mutations, and we are excited to support Clovis’ clinical development program and help identify patients who are most likely to benefit from rucaparib,” Myriad President and CEO Mark C. Capone said in a press release. “This agreement further solidifies Myriad’s leadership role in developing best-in-class companion diagnostics for use with PARP inhibitors and supports our goal of being the worldwide leader in personalized medicine.”
Rubraca is a poly (ADP-ribose) polymerase (PARP) inhibitor with potential as an anti-cancer agent that targets the DNA repair enzyme poly-ADP ribose polymerase-1 (PARP-1).
BRCA genes are fundamental to the normal functioning of DNA repair mechanisms. But when cancer cells have faulty BRCA proteins, they rely on the PARP signaling pathway to accurately repair DNA damages. As such, by blocking this enzyme, the DNA inside tumorous cells with damaged BRCA genes is less likely to be repaired, causing the cells to die. This has been shown to halt tumor growth.
Under the collaboration, Myriad, based in Salt Lake City, Utah, will apply for supplementary premarket approval (sPMA) under its existing PMA for BRACAnalysis CDx to include Rubraca. The application will fulfill a post-approval regulatory commitment to the FDA. BRACAnalysis CDx is an in vitro diagnostic test designed to qualitatively detect and classify variants of the BRCA1 and BRCA2 genes.
“This partnership with Myriad Genetics not only enables us to fulfill our post-marketing commitment to the FDA, but will enhance the companion diagnostic information already available to physicians and patients, providing a robust toolkit for personalizing treatment of patients with BRCA1/2 mutations,” said Patrick J. Mahaffy, president and CEO of Clovis Oncology in Boulder, Colorado.