Seattle Genetics gets FDA nod for breast cancer drug Tukysa

Seattle Genetics has secured approval from the US Food and Drug Administration (FDA) for its Tukysa (tucatinib) to treat people with advanced unresectable or metastatic HER2-positive breast cancer.

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.
 

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