The regulator has approved Tukysa in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have secured one or more prior anti-HER2-based regimens in the metastatic setting.
Tukysa, an oral medicine, is a tyrosine kinase inhibitor of the HER2 protein. It showed to inhibit phosphorylation of HER2 and HER3 under in-vitro lab studies.
Earlier, the company secured the breakthrough therapy designation and priority review for Tukysa and assessed the application for approval under the Real-Time Oncology Review (RTOR) pilot programme.
Tukysa, in combination with trastuzumab and capecitabine, was assessed in the HER2CLIMB randomized (2:1) double-blind and placebo-controlled trial.
The study recruited 612 patients with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received, either separately or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1).
According to the company, patients who secured Tukysa in combination with trastuzumab and capecitabine had a 46% reduction in the risk of cancer progression or death (PFS) compared to patients who received trastuzumab and capecitabine alone.
Seattle Genetics CEO Dr Clay Siegall said: “We’re pleased to have collaborated with the FDA on our second expedited real-time oncology review, enabling us to rapidly bring this new targeted medicine to patients.
“TUKYSA has shown impressive results in people with HER2-positive metastatic breast cancer, including in patients with active brain metastases, and offers patients an effective medicine following previous treatment with other anti-HER2 agents in the metastatic setting.”
In February, Seattle Genetics and Astellas Pharma have secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for Padcev in combination with Merck’s anti-PD-1 therapy Keytruda to treat advanced bladder cancer.
Padcev is a first-in-class antibody-drug conjugate (ADC), which is directed against Nectin-4, a protein situated on the surface of cells and highly expressed in bladder cancer.