FDA Approves Tucatinib in Combination With Trastuzumab, Capecitabine for HER2-Positive Metastatic Breast Cancer

This approval is a part of the first Project Orbis partnership between the FDA, Health Sciences Authority, and Swissmedic.

Officials from the FDA have approved tucatinib (Tukysa, Seattle Genetics Inc) in combination with trastuzumab and capecitabine (chemotherapy) for the treatment of adult patients with advanced forms of human epidermal growth factor receptor 2 (HER2)-positive breast cancer that cannot be removed with surgery or has spread to other parts of the body. This also includes individuals who have received 1 or more prior treatments, according to the FDA.

This approval is a part of the first Project Orbis partnership between the FDA, Health Sciences Authority, and Swissmedic.

“The FDA’s Project Orbis provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international collaborators,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research in a press release. “We are pleased to work with our Singapore and Switzerland colleagues for the first time, and to continue working alongside our Australian and Canadian colleagues as we facilitate new treatment options for patients—like today’s first new molecular entity under Project Orbis.”

The approval is based on the results of a clinical trial that enrolled 612 patients with HER2-positive advanced unresectable or metastatic breast cancer, having prior treatment with trastuzumab, pertuzumab, and ado-trastuzumab emtansine.

Patients who were previously treated and had stable brain metastases or previously treated with growing or untreated brain metastases were eligible for the clinical trial. The median progression-free survival (PFS) in patients who received tucatinib, trastuzumab, and capecitabine was 7.8 months compared with 5.6 months for patients who received the placebo, trastuzumab, and capecitabine.

In addition, the median overall survival in patients who received tucatinib, trastuzumab, and capecitabine was 21.9 months compared with 17.4 months in patients who received placebo, trastuzumab, and capecitabine. In patients with brain metastases at baseline who received tucatinib, trastuzumab, and capecitabine, the median PFS was 7.6 months compared with 5.4 months in patients who received placebo, trastuzumab, and capecitabine.

Adverse effects reported in patients taking tucatinib were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.

REFERENCE

FDA approves first new drug under international collaboration, a treatment option for patients with HER2-positive metastatic breast cancer. Silver Spring, MD; FDA: April 17, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-drug-under-international-collaboration-treatment-option-patients-her2?utm_campaign=FDA%20approves%20new%20treatment%20for%20HER2-positive%20metastatic%20breast%20cancer&utm_medium=email&utm_source=Eloqua. Accessed April 17, 2020.