FDA Approves Dako Assays as CDx for Genentech Breast Cancer Drug

Dako today said that the US Food and Drug Administration has approved two assays for use as companion diagnostics for a Genentech drug targeting HER2-positive metastatic breast cancer.

FDA simultaneously approved Dako’s HercepTest and HER2 IQFISH pharmDx assays and Genentech’s drug Kadcyla (ado-trastuzumab emtansine).

Kadcyla is for patients with HER2-positive metastatic breast cancer who have been previously treated with Genentech’s Herceptin (trastuzumab) and a taxane chemotherapy.

Dako, an Agilent company, and Genentech, a Roche company, have been collaborating on the development of companion diagnostics for Genentech’s drugs for a few years. In May 2012 the two firms inked a pact to collaborate on the FDA submission of Dako’s assays for Kadcyla.

A month later the HercepTest and HER2 FISH pharmDx were approved by FDA as companion diagnostics for Genentech’s breast cancer drug Perjeta (pertuzumab). In late 2011, FDA gave the thumbs up to Dako’s HER2 CISH pharmDx kit as a companion diagnostic for Herceptin in the treatment of breast cancer patients.

And in 2010, the agency approved the use of HercepTest and HER2 FISH pharmDx to help guide treatment of patients with metastatic gastric or gastroesophageal junction adenocarcinoma with Herceptin. cancer
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