NEW YORK – Seagen on Monday said the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has authorized its anti-HER2 agent tucatinib (Tukysa) with trastuzumab (Genentech's Herceptin) and chemotherapy for HER2-positive, locally advanced, or metastatic breast cancer patients who have previously received at least two prior anti-HER2 treatment regimens.
The MHRA's decision to approve the combination in the UK comes a week after the European Commission granted approval to the same regimen in the EU. In April 2020, the US Food and Drug Administration approved the combination in the US. Importantly, the drug is approved to treat breast cancer patients whose disease has spread to the brain.
All three approvals are based on data from the randomized, Phase II HER2CLIMB trial, which pitted the tucatinib-trastuzumab-chemo combination against trastuzumab, chemo, and placebo. The median progression-free survival for patients treated with the tucatinib combination was 7.8 months versus 5.6 months for those on the trastuzumab-chemo arm. The median overall survival for patients treated with the three agents was 21.9 months versus 17.4 months for patients treated with just the two.
In September 2020, Seagen, formerly named Seattle Genetics, out licensed tucatinib to Merck for commercialization outside of the US, Canada, and Europe.
Following MHRA's authorization, bodies such as the UK's National Institute of Health and Care Excellence (NICE) will appraise the clinical and cost effectiveness of the drug and decide if the National Health Service should fund it for breast cancer patients. "We look forward to further collaborating with the national reimbursement bodies to ensure it is available to adult patients," Seagen CEO Clay Siegall said in a statement.