Pfizer (PFE.US) Tukysa approved in the United States for first-line breast cancer treatment

Zhitong Finance APP has learned that Pfizer (PFE.US) announced on Wednesday that the U.S. Food and Drug Administration (FDA) has approved its tyrosine kinase inhibitor Tukysa (tucatinib) as part of a combination regimen for first-line maintenance treatment of a certain type of breast cancer.

This approval allows Tukysa to be used for adult patients with HER2-positive (HER2+) breast cancer who have received induction treatment with trastuzumab and pertuzumab. Trastuzumab and pertuzumab are two anti-cancer drugs sold by Roche (RHHBY.US) under the Herceptin and Perjeta brands, respectively.

This decision is supported by data from Pfizer's HER2CLIMB-05 Phase III trial. In this trial, Tukysa combined with trastuzumab and pertuzumab for patients with HER2-positive metastatic breast cancer (MBC) met the primary endpoint of progression-free survival and demonstrated good safety.

This oral medication had previously been approved in the United States as a subsequent treatment option for adults with advanced, HER2-positive, unresectable or metastatic breast cancer, and can be used in combination with chemotherapy, capecitabine, and trastuzumab.

Pfizer closed up 1.8% on Wednesday and has gained 18% year to date.