Seagen Inc. (NASDAQ: SGEN) recently announced that its drug, Tucatinib, has been granted priority review by the U.S. Food and Drug Administration (FDA). Tucatinib, which is marketed as Tukysa, is an oral tyrosine kinase inhibitor (TKI) designed to target the HER2 gene in breast cancer. The drug is approved in combination with Roche’s Herceptin® (trastuzumab) and capecitabine for the treatment of patients with metastatic, HER2-positive breast cancer.
The FDA’s priority review of Tucatinib is based on data from the HER2CLIMB trial. This trial evaluated the efficacy and safety of Tucatinib in combination with trastuzumab and capecitabine versus trastuzumab and capecitabine alone in patients with HER2-positive metastatic breast cancer. The results of the trial showed that Tucatinib had a significant survival benefit over the control.
Tucatinib is an important asset for Seagen as it has the potential to become a first-line therapy for HER2-positive metastatic breast cancer. The drug is distinctive in that it has a favorable safety profile and is the only tyrosine kinase inhibitor that is approved to be used in combination with trastuzumab and capecitabine. It has also demonstrated a positive impact on progression-free survival and overall survival.
The FDA’s priority review of Tucatinib will expedite the review process and could lead to an approval decision within six months. This would be a major milestone for Seagen as an approval for Tucatinib would open up a new market for the company and could bring in significant revenues.
Should Tucatinib get approved by the FDA, it would be a major win for Seagen and its shareholders. The drug has the potential to become a first-line therapy for HER2-positive metastatic breast cancer and could revolutionize the way breast cancer is treated. Seagen’s stock could see a significant surge in value if Tucatinib is approved by the FDA.