SALT LAKE CITY and BOULDER, Colo., April 27, 2017 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN) and Clovis Oncology, Inc. (NASDAQ:CLVS) today announced a companion diagnostic collaboration to support a post-marketing regulatory commitment related to Clovis' PARP inhibitor, Rubraca. Financial terms of the deal were not disclosed.
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.
"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.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G
Myriad Genetics Media Contact: Ron Rogers, (908) 285-0248 [email protected] Investor Contact: Scott Gleason, (801) 584-1143 [email protected] Clovis Oncology Anna Sussman, 303-625-5022 [email protected] or Breanna Burkart, 303-625-5023 [email protected]
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