FDA approves tucatinib for HER2-positive metastatic breast cancer

  • FDA
  • 17 Apr 2020

  • curated by Pavankumar Kamat
  • Univadis Clinical Summaries
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • The US Food and Drug Administration (FDA) has approved tucatinib for the treatment of HER2-positive metastatic breast cancer.
  • The recommended dose is 300 mg taken orally twice daily with or without food.

Why this matters

  • Tucatinib is the first new drug approved under Project Orbis, an international collaboration.

Key highlights

  • The approval was based on the phase 3 HER2CLIMB trial.
  • Previously treated patients with HER2-positive metastatic breast cancer (n=612) were randomly assigned to either tucatinib or placebo in combination with trastuzumab and capecitabine. 
  • Median PFS was 7.8 months in the tucatinib group vs 5.6 months in the placebo group.
    • PFS outcomes in the brain metastases subgroup followed a similar pattern.
  • Median OS was 21.9 months in the tucatinib group vs 17.4 months in the placebo group.
  • The most common adverse events associated with tucatinib were diarrhea, palmar-plantar erythrodysesthesia syndrome, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.
  • Tucatinib can cause diarrhea associated with dehydration, acute kidney injury, and death.
  • Tucatinib can also cause severe hepatotoxicity; liver function tests are warranted.

For Prescribing Information, click here.