FDA Approval Insights: Tucatinib and Trastuzumab in HER2+ mCRC


Dr Strickler discusses the FDA approval of tucatinib plus trastuzumab in metastatic colorectal cancer, key efficacy and safety findings from the MOUNTAINEER trial, and ongoing research seeking to address remaining unmet needs in this population.

Welcome to OncLive On Air®! I’m your host today, Ashling Wahner.

OncLive On Air® is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with John H. Strickler, MD, an associate professor of medicine in the Department of Medical Oncology at Duke Cancer Institute in Durham, North Carolina, about the FDA approval of tucatinib (Tukysa) plus trastuzumab (Herceptin) in metastatic colorectal cancer (mCRC).

On January 19, 2023, the FDA approved the combination of tucatinib and trastuzumab in adult patients with pretreated, RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer. This approval was supported by findings from the phase 2 MOUNTAINEER trial (NCT03043313), in which, at a median follow-up of 20.7 months, patients who received the regimen had a confirmed objective response rate of 38.1% and a median duration of response of 12.4 months.

In our exclusive interview, Dr Strickler discussed the significance of this approval, key efficacy and safety findings from MOUNTAINEER, and how ongoing research is seeking to address remaining unmet needs for patients with HER2-positive mCRC with resistance mutations.


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