Posted by Michael Wonder on 29 Apr 2017
Myriad Genetics and Clovis Oncology sign agreement for use of FDA approved BRACAnalysis CDx test to identify patients with germline BRCA mutations for Rubraca (rucaparib) treatment
27 April 2017 - Myriad Genetics and Clovis Oncology today announced a companion diagnostic collaboration to support a post-marketing regulatory commitment related to Clovis’ PARP inhibitor, Rubraca.
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 fulfil 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 tumours 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 counselling.
