Seagen's Tukysa Becomes First FDA-Approved Treatment For HER2-Positive Metastatic Colorectal Cancer

The FDA has granted accelerated approval to Seagen Inc's SGEN Tukysa (tucatinib) in combination with trastuzumab for colorectal cancer.
The approval covers adult patients with RAS wild-type, HER2-positive unresectable, or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
Tukysa is approved under the FDA's Accelerated Approval Program based on tumor response rate and durability of response from the phase 2 MOUNTAINEER clinical trial.
This is the first FDA-approved treatment for HER2-positive metastatic colorectal cancer.
Results from the MOUNTAINEER trial showed a 38% overall response rate (ORR) in the patients who received TUKYSA in combination with trastuzumab.
Complete responses were observed in 3.6% of patients, and partial responses were observed in 35%. The median duration of response (DOR) was 12.4 months.
Over the last couple of months, Seagen gained attention after reports regarding its acquisition by pharma giant Merck & Co Inc MRK. However, the talks were stalled over price negotiations. No further update is available for the said deal.
Price Action: SGEN shares closed higher by 1.16% at $132.00 on Thursday.
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