The company is seeking approval for tukysa and trastuzumab combination for the treatment of HER2-positive colorectal cancer in adult patients who have received at least one treatment regimen previously for unresectable or metastatic disease.
Tukysa is a tyrosine kinase inhibitor of the HER2 protein and is approved in 38 countries.
In lab studies, the oral medicine inhibited phosphorylation of HER2 and HER3, which resulted in inhibition of cell growth and demonstrated anti-tumour activity in HER2-expressing tumour cells.
It also showed increased anti-tumour activity in vitro and in vivo in combination with the anti-HER2 antibody trastuzumab.
The company stated that the submission of sNDA is based on the data obtained from the pivotal Phase II MOUNTAINEER trial.
In July this year, the results from the trial were presented at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer.
Seagen Late-Stage Development head and senior vice-president Marjorie Green said: “There are currently no FDA-approved therapies for metastatic colorectal cancer that specifically target HER2.
“The FDA’s prioritisation 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.”
The regulator has set 19 January next year as the target action date for its decision, under the Prescription Drug User Fee Act (PDUFA).
It has granted Breakthrough Therapy Designation for tucatinib and trastuzumab combination to treat unresectable or metastatic HER2-positive colorectal cancer in adult patients, this July.
The combination treatment is indicated to treat adult colorectal cancer patients who have received fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy previously based on the MOUNTAINEER trial results.
In February, the company commenced the international, randomised Phase III MOUNTAINEER-03 clinical trial.
The trial has been designed to assess tucatinib and trastuzumab combination along with standard chemotherapy versus chemotherapy given with or without cetuximab or bevacizumab in first-line HER2-positive metastatic colorectal cancer.
It is planned to be served as a confirmatory trial in the US and is expected to support filings across the world.