Update: FDA approves tucatinib (Tukysa) for metastatic Her2-positive breast cancer

Contents

APPROVAL AT A GLANCE

This report is about: 

FDA approval of the drug tucatinib (Tukysa) in combination with chemotherapy for treating metastatic Her2-positive breast cancer.

Why is this approval important?

Recurrent metastatic Her2-positive breast cancer is an aggressive type of cancer with limited options, especially for people whose disease has spread to the brain. On April 17, 2020, the U.S. Food and Drug Administration (FDA) granted approval of Tukysa in combination with chemotherapy for the treatment of advanced, Her2-positive breast cancer in people who have received at least one prior therapy for metastatic disease.

Research findings:

FDA approval of Tukysa in combination with chemotherapy was based on previous research, which we reported in this XRAY review. The HER2CLIMB study looked at 612 patients with metastatic Her2-positive breast cancer. For participants who received Tukysa plus chemotherapy:

• at 1 year, the risk of disease progression or death was 46 percent lower compared to the placebo group.
• at 1 year, the risk of disease progression or death was 52 percent lower among participants with brain metastases compared to those in the placebo group.
• at 2 years, the risk of death was 34 percent lower.
• almost twice as many participants experienced a reduction in the size or a disappearance of their cancer compared to the placebo group.

Most adverse events that occurred were not severe, but included:

• diarrhea
• hand-foot syndrome
• nausea
• fatigue
• vomiting

The FDA warns that Tukysa can cause serious side effects, including severe diarrhea associated with dehydration, acute kidney and liver damage.

What does this mean for me?

If you have been diagnosed with locally advanced or metastatic Her2-positive breast cancer, you may want to talk to your doctor about whether Tukysa is right for you.

Share your thoughts on this XRAYS article by taking our brief survey.
 

Reference:

FDA Approves First New Drug Under International Collaboration, A Treatment Option for Patients with HER2-Positive Metastatic Breast Cancer. FDA Website. April, 2020.
 

Disclosure

FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.