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EMA Committee Recommends Approval for Seagen's Tukysa in Advanced HER2-Positive Breast Cancer

NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval for tucatinib (Seagen's Tukysa) in combination with trastuzumab (Genentech's Herceptin) and chemotherapy for HER2-positive locally advanced or metastatic breast cancer patients previously treated with two prior anti-HER2 treatment regimens.

The CMHP recommendation was based on findings from the Phase II HER2CLIMB study, which evaluated the tucatinib-trastuzumab-capecitabine regimen in HER2-positive metastatic breast cancer against placebo and trastuzumab-capecitabine.

In that study, 33 percent of heavily pretreated patients taking tucatinib were alive at one year without their disease progressing compared to 12 percent in the comparator arm. Overall survival at two years was 44 percent in the tucatinib-combination group and 26 percent in the placebo group. The median overall survival was 21.9 months for those receiving tucatinib and 17.4 months for those in the placebo and trastuzumab-capecitabine arm. A Phase III study of tucatinib in HER2-positive breast cancer is ongoing.

"We are pleased the CHMP has recognized Tukysa as a meaningful clinical advance for people with advanced HER2-positive metastatic breast cancer, including those with cancer that has spread to the brain," Roger Dansey, chief medical officer at Seagen, said in a statement. "This opinion brings us one step closer to making Tukysa available to patients in the EU and aligns with our commitment to bring innovative therapies to patients around the world."

The European Commission will now review the CHMP's opinion and issue a final decision. Tucatinib is already approved to treat HER2-positive breast cancer in the United States, Canada, Switzerland, Singapore, and Australia. Seagen is also studying the drug in HER2-postive colorectal cancer and gastric cancer.