NEW YORK (GenomeWeb) – Clovis Oncology has partnered with Myriad Genetics to meet a post-marketing requirement for its PARP inhibitor Rubraca (rucaparib).
Myriad said it will submit a supplementary premarket approval application for its BRACAnalysis CDx, which the US Food and Drug Administration originally approved in December 2014 alongside AstraZeneca's PARP inhibitor Lynparza (olaparib).
Rubraca was granted accelerated approval by the FDA in December for the treatment of advanced ovarian cancer patients who have deleterious mutations in BRCA1 and BRCA2, and who have received two or more chemotherapies. In approving the drug, the FDA asked Clovis to submit analytical and clinical validation of a companion diagnostic that will enable the evaluation of patients' germline BRCA status.
Myriad's test gauges germline BRCA1/2 mutations. "The companion diagnostic test approved with Rubraca does not discriminate between germline and somatic mutations," Myriad said in a statement. "Knowledge of germline status is important to provide patients appropriate counseling."
The FDA initially approved Rubraca with Foundation Medicine's next-generation sequencing based companion diagnostic, FoundationFocus CDxBRCA. The test can gauge germline and somatic BRCA variants — which can potentially identify more patients who could benefit from therapy — but doesn't distinguish between them.
Foundation's test also has other limitations. The test label (see pdf below) notes that its performance is not established for insertions longer than 10 nucleotides, deletions longer than 12 nucleotides, alterations residing in polyC homopolymer runs, homozygous deletions, or large rearrangements. Myriad's BRCA test can gauge large rearrangements.
"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," added Clovis CEO Patrick Mahaffy.