Regulatory Seagen’s Tukysa on FDA’s priority review list

Seagen’s Tukysa on FDA’s priority review list


The FDA is set to deliver its judgment on the Tucatinib (Tukysa, Seagen) and trastuzumab (Herceptin, Genentech) combination for the treatment of patients with colorectal cancer. The verdict is expected to be out by late January next year. 

Both drugs have been able to score a priority review only two months after Seagen first shared the results of its Tukysa-Herceptin combo from its phase 2 MOUNTAINEER trial. The results of the trial were made public at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer.

As was observed in the Mountaineer trial, the Seagen-Roche combination helped colorectal cancer patients live a median of 24 months. Patients on the medication also lived at a median of 8 months without any further tumor growth. 

The trial included 117 patients with HER2-positive unresectable colorectal cancer and all trial participants had received standard therapies in the past but not an anti-HER2 therapy. Patients in the trial either received both or one of the therapies. 84 patients received both therapies after a median follow-up of 20 months. Researchers confirmed an ORR (Objective Response Rate) of 38.1%. This served as the primary endpoint of the trail and PFS, OS, safety, and tolerability served as secondary endpoints.

Despite the fact that this is only a phase 2 study conducted with a small group of patients, Sebastian Stintzing, professor at the Charité Universitätsmedizin in Germany is optimistic about the findings of the trial. Especially since HER2 positivity is quite rare.

Seagen also launched a randomized phase 3 MOUNTAINEER trial this year where researchers will give patients a combination of Tukysa and Herceptin supplemented either by standard chemotherapy with or without cetuximab or bevacizumab. This will act as the first-line treatment for HER2-positive metastatic colorectal cancer patients. The company already has the approval of around a quartet of cancer treatments and had a revenue of approxiamely $2 billion just this past year.

FDA approval will play a significant role in the treatment of metastatic colorectal cancer that specifically targets HER2 because as of yet no FDA-approved therapy exists to treat it. Tukysa is an oral tyrosine kinase inhibitor that is receptive to HER2 and does not significantly reduce EGFR. The drug is approved in the United States if it is used in a combination with Herceptin and capecitabine but only by patients who have received at least a year prior anti-HER2-based regimen in the metastatic setting.

Moreover, Seagen has also predicted that around 151,000 people in the U.S. alone will be diagnosed with colorectal cancer as there is already a steady rise in older adult patients.

On the business front, there were talks about a potential $40 billion merger between Seagen and pharma giant Merck & Co. which has now been put on the back burner due to pricing problems. Seagen is also on the lookout for a new Chief Operating Officer after former CEO Clay Seigall stepped down following accusations of domestic violence. Currently Chief Medical Officer, Roger Dansey is serving as CEO of the company.

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