Seagen announces fda accelerated approval of tukysa® (tucatinib) in combination with trastuzumab for people with previously treated ras wild-type, her2-positive metastatic colorectal cancer

Bothell, wash.--( business wire )--seagen inc. (nasdaq: sgen) today announced that the u.s. food and drug administration (fda) has granted accelerated approval to tukysa® (tucatinib) in combination with trastuzumab for adult patients with ras wild-type, her2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. tukysa is approved under the fda's accelerated approval program based on tumor response rate and durability of response from the phase 2 mountaineer clinical trial. continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. this is the first fda-approved treatment in her2-positive metastatic colorectal cancer. the fda previously granted breakthrough therapy designation and priority review for tukysa in this setting.
SGEN Ratings Summary
SGEN Quant Ranking