On April 27, 2017 Myriad Genetics, Inc. (NASDAQ: MYGN) and Clovis Oncology, Inc. (NASDAQ:CLVS) reported a companion diagnostic collaboration to support a post-marketing regulatory commitment related to Clovis’ PARP inhibitor, Rubraca (Press release, Myriad Genetics, APR 27, 2017, View Source [SID1234518718]). Financial terms of the deal were not disclosed.
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Under the agreement, Myriad will submit a supplementary premarket approval (sPMA) application under its existing PMA for BRACAnalysis CDx to include Rubraca. The Myriad sPMA submission will fulfill a post-approval regulatory commitment by Clovis Oncology to the Food and Drug Administration (FDA) for Rubraca. In December 2016, Rubraca was approved for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a deleterious BRCA mutation as identified by an FDA-approved companion diagnostic test. The companion diagnostic test approved with Rubraca does not discriminate between germline and somatic mutations. Knowledge of germline status is important to provide patients 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," said Mark C. Capone, president and CEO, Myriad Genetics. "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."
"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, Clovis Oncology.
About Rubraca (rucaparib)
Rubraca is a PARP inhibitor indicated as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. The indication for Rubraca is approved under the FDA’s accelerated approval program based on objective response rate and duration of response, and is based on results from two multicenter, single-arm, open-label clinical trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Please visit rubraca.com for more information. About BRACAnalysis CDx BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR. BRACAnalysis CDx was reviewed and approved by the FDA in December 2014 for use as a companion diagnostic to aid in identifying ovarian cancer patients eligible for treatment with AstraZeneca’s PARP inhibitor, olaparib. This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108.