Trastuzumab + Tucatinib & Colorectal Cancer (CRC) (Her2+)

Approval status

The FDA has granted accelerated approval for Trastuzumab + Tucatinib in treating Colorectal Cancer (CRC) (Her2+). This approval is specifically for cases where the cancer has progressed following certain chemotherapy regimens and anti-VEGF therapy. The approval was based on results from the phase II MOUNTAINEER trial (NCT03043313). In this trial, 84 patients were treated with tucatinib plus trastuzumab, achieving an overall response rate of approximately 38%. The median duration of response was 12.4 months (1, 2)

However, the European Medicines Agency (EMA) has not yet approved this use.

References

(1) [fda-grants-accelerat…