Seagen Inc. (NASDAQ:SGEN) has announced that the European Medicines Agency’s Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion for approval of TUKYSA® (tucatinib). The approval is for TUKYSA in combination with capecitabine and trastuzumab in treating HER2-2 positive metastatic or locally advanced breast cancer patients that had previously received two anti-HER2 treatment regimens.
Seeking approval for TUKYSA in the EU
TUKYSA is the company’s small molecule, orally available HER2 tyrosine kinase inhibitor (TKI) which is the protein that leads to cancer cell growth. The European Commission will consider the positive opinion from CHMP to approve TUKYSA in the region. Already TUKYSA has approval in Canada, the US, Switzerland, Australia, and Singapore.
Roger Dansey the company’s chief medical officer said that they are delighted to receive a positive opinion for TUKYSA from the CHMP. He said that this is a significant clinical development for patients with advanced HER2-positive breast cancer as well as those whose cancer has spread to the brain. Roger said that the positive opinion takes the company closers to avail TUKYSA to patients across the European Union and also aligns with Seagen’s commitment to delivering innovative therapies to patients globally.
HER2CLIMB results supported a positive opinion
Most importantly the HER2CLIMB study results supported the grant of the positive opinion. The HER2CLIMB was a randomized, placebo-controlled, double-blind, active comparator, the study that enrolled 612 subjects. The patients had HER2-positive unresectable locally advanced or metastatic breast cancer and had previously received pertuzumab, trastuzumab, and ado-trastuzumab emtansine either in combination or separately.
Primary endpoint results showed that patients treated with TUKYSA in combination with capecitabine and trastuzumab had a 46% reduction in cancer progression or death risk compared to those that received only capecitabine and trastuzumab.Also, a secondary endpoint indicated that there was a reduced risk of death by 34% when TUKSYA was used in combination compared to when capecitabine or trastuzumab alone was used.TUKSYA received approval in the US based on these results as a combination therapy with capecitabine or trastuzumab in treating advance metastatic or advanced HER2-positive breast cancer patients.