FDA Accelerated Approval of Tucatinib/Trastuzumab for HER2+ Metastatic CRC May ‘Improve Access’ to Treatment

Approval Alert | <b>Tucatinib Plus Trastuzumab for Advanced HER2+ Metastatic CRC </b>

An expert from the Duke University School of Medicine describes how the FDA approval of tucatinib plus trastuzumab in HER2-positive metastatic colorectal cancer will improve access to treatment.

The FDA approval of tucatinib (Tukysa) in combination with trastuzumab (Herceptin) may improve treatment access and meaningful clinical benefit for patients with HER2-positive metastatic colorectal cancer (CRC), according to John H. Strickler, MD.

In an interview with CancerNetwork®, Strickler, a medical oncologist and associate professor of medicine at Duke University School of Medicine, commented on the FDA’s accelerated approval of tucatinib plus trastuzumab in HER2-positive CRC.

The approval was based on findings from the phase 2 MOUNTANIEER trial (NCT03043313) which reported an overall response rate of 38% (95% CI, 28%-49%) by blinded independent central review. Moreover, the complete response rate was 3.6% and the partial response rate was 35%. Additionally, investigators reported a median duration of response of 12.4 months (95% CI, 8.5-20.5).

Moreover, the median progression-free survival was 8.2 months (95% CI, 4.2-10.3) by blinded independent central review. Patients treated with the combination had a median overall survival of 24.1 months (95% CI, 20.3-36.7).

The approval of tucatinib and trastuzumab is the first approved treatment option for HER2-positive metastatic CRC and validates clinical testing for screening for HER2-positive tumors.

Transcript:

There [were] therapies available and listed in our national guidelines as options [for metastatic CRC] but there [were] no anti–HER2 regimens that were FDA-approved for patients with HER2-positive metastatic colorectal cancer that is. This [is] the first approval ever for patients with HER2-positive metastatic colorectal cancer.

It validates the use of testing to look for HER2 and provides patients with meaningful clinical benefit. The approval helps with access whether that patient is at a large medical center or small medical center. It's something that improves access nationwide for patients.

Reference

Seagen announces FDA accelerated approval of Tukysa (tucatinib) in combination with trastuzumab for people with previously treated RAS wild-type, HER2-positive metastatic colorectal cancer. News release. FDA. January 19, 2023. Accessed January 19, 2023. https://bwnews.pr/3Xpzbqn