Date: 2017-04-27
Type of information: Collaboration agreement
Compound: BRACAnalysis CDx for use with Rubraca® (rucaparib)
Company: Clovis Oncology (USA - CO) Myriad Genetics (USA - UT)
Therapeutic area: Cancer - Oncology - Diagnostic
Type agreement: collaboration
Action mechanism:
- companion diagnostic. 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 are identified by 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.
Disease: ovarian cancer
Details:
- • On April 27, 2017, Myriad Genetics and Clovis Oncology announced a companion diagnostic collaboration to support a post-marketing regulatory commitment related to Clovis' PARP inhibitor, Rubraca® (rucaparib). 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 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.
Financial terms: Financial terms of the deal were not disclosed.
Latest news:
Is general: Yes
