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.
  • Photo Via Company
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