UK and European approval for Seagen's Tukysa

The UK subsidiary of US biotech firm Seagen (Nasdaq: SGEN) today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in Great Britain for Tukysa (tucatinib) in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens.

The European centralized marketing authorization granted for Tukysa earlier this month by the European Commission is valid in Northern Ireland but not in the UK since it came after the end of the Brexit process on December 31. The MHRA had previously granted Tukysa a Promising Innovative Medicine (PIM) designation.

“Every year, an estimated 55,000 people are diagnosed with breast cancer in the UK, of which up to one in five are estimated to have HER2-positive tumours,” said Dr Alicia Okines, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, adding: “The authorization of tucatinib in combination with trastuzumab and capecitabine is a significant step forward for adult patients with advanced, incurable HER2-positive breast cancer. With this authorization, our patients, including those with disease that has spread to the brain, may have a new alternative therapeutic option that offers a meaningful survival benefit with a generally manageable side effect profile,” she added.