FDA grants priority review to Tukysa regimen for advanced colorectal cancer
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The FDA granted priority review to tucatinib in combination with trastuzumab for treatment of certain adults with colorectal cancer.
The designation applies to use of the agent by patients who received at least one prior treatment for unresectable or metastatic disease.
The agency is expected to make a decision on approval by Jan. 19.
Tucatinib (Tukysa, Seagen) is an oral tyrosine kinase inhibitor that is highly selective for HER2 without significant inhibition of EGFR. The agent is approved in the United States in combination with trastuzumab (Herceptin, Genentech) and capecitabine for treatment of adults with advanced unresectable or metastatic HER2-positive breast cancer who received at least one prior anti-HER2-based regimen in the metastatic setting.
HER2 is overexpressed in approximately 3% to 5% of metastatic colorectal cancers.
A supplemental new drug application seeking approval for the colorectal cancer indication is based on results of the phase 2 MOUNTAINEER trial, which included 117 patients with HER2-positive unresectable or metastatic colorectal cancer. All study participants had received prior standard therapies but had not received prior anti-HER2 therapy.
Patients received tucatinib with trastuzumab or as monotherapy. Confirmed objective response rate per blinded independent central review served as the primary endpoint. Secondary endpoints included duration of response, PFS, OS, safety and tolerability.
Eighty-four patients (median age, 55 years; range, 24-77) received tucatinib with trastuzumab. After median follow-up of 20.7 months, researchers reported a confirmed ORR of 38.1% (95% CI, 27.7-49.3). Researchers reported median PFS of 8.2 months (95% CI, 4.2-10.3) and median OS of 24.1 months (95% CI, 20.3-36.7).
“There are currently no FDA-approved therapies for metastatic colorectal cancer that specifically target HER2,” Marjorie Green, MD, senior vice president and head of late-stage development for Seagen, said in a company-issued press release. “The FDA’s prioritization of our application for tucatinib in combination with trastuzumab supports our belief in its significant potential to benefit people with previously treated HER2-positive metastatic colorectal cancer.”
Earlier this year, Seagen launched the randomized phase 3 MOUNTAINEER-03 trial. Researchers will assign patients to tucatinib with trastuzumab and standard chemotherapy, or to chemotherapy with or without cetuximab (Erbitux, Eli Lilly) or bevacizumab (Avastin, Genentech) as first-line treatment for HER2-positive metastatic colorectal cancer.
References:
- Seagen announces results from pivotal MOUNTAINEER trial demonstrating clinically meaningful antitumor activity of Tukysa (tucatinib) in combination with trastuzumab in previously treated HER2-positive metastatic colorectal cancer (press release). https://investor.seagen.com/press-releases/news-details/2022/Seagen-Announces-Results-from-Pivotal-MOUNTAINEER-Trial-Demonstrating-Clinically-Meaningful-Antitumor-Activity-of-TUKYSA-tucatinib-in-Combination-with-Trastuzumab-in-Previously-Treated-HER2-Positive-Metastatic-Colorectal-Cancer/default.aspx. Published July 2, 2022. Accessed Sept. 19, 2022.
- Seagen announces Tukysa (tucatinib) in combination with trastuzumab granted priority review by FDA for previously treated HER2-positive metastatic colorectal cancer (press release). https://investor.seagen.com/press-releases/news-details/2022/Seagen-Announces-TUKYSA-tucatinib-in-Combination-with-Trastuzumab-Granted-Priority-Review-by-FDA-for-Previously-Treated-HER2-Positive-Metastatic-Colorectal-Cancer/default.aspx. Published Sept. 19, 2022. Accessed Sept. 19, 2022.
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