Firms will file for FDA approval of Dako tests alongside Genentech’s T-DM1.
Dako signed an agreement with Genentech to collaborate on FDA regulatory submissions of two Dako tests as companion diagnostics for Genentech’s trastuzumab emtansine (T-DM1), a candidate for advanced Her2-positive breast cancer. The submission would cover use of HercepTest™ and HER2 FISH pharmDx™ to identify patients who may be eligible for treatment with T-DM1.
In March Roche, Genentech’s parent company, confirmed plans to file regulatory approval applications for T-DM1, an antibody-drug conjugate, to both FDA and the European authorities later this year. The decision came on the back of positive data from the first Phase III study evaluating the drug in the treatment of metastatic breast cancer (mBC). T-DM1 combines Roche’s Herceptin (trastuzumab) and ImmunoGen’s cancer-killing agent DM1 using ImmunoGen’s linker technology.
Today’s announcement from Dako and Genentech comes on the heels of another collaboration between the firms. Last December the companies decided to collaborate on the regulatory submissions of HercepTest and HER2 FISH pharmDx as companion diagnostics for Pertuzumab. Roche has submitted a BLA and MAA for people with previously untreated, Her2-positive metastatic breast cancer.
Dako’s deal with Genentech is in line with its strategy to combine its strengths with pharmaceutical companies to grow its offering of companion diagnostic assays. The company has cancer companion diagnostic deals with several firms including Amgen, Bristol-Myers Squibb, and OSI Pharmaceuticals.