Seattle Genetics’ Breast Cancer Drug Approved Months Ahead of Schedule

“The addition of TUKYSA to trastuzumab and capecitabine has the potential to become a standard of care for people with HER2-positive metastatic breast cancer,” said Eric Winer, MD, who heads the breast oncology division at Dana-Farber. “Cancer spreads to the brain in up to half of patients with HER2-positive metastatic breast cancer” he added.

With TUKYSA approval, Seattle now has 3 commercial products including PADCEV and ADCETRIS. This approval comes 4 months ahead of the August 20th PDUFA date. Shares rose 3% on the news, bringing the stock’s year-to-date gain to 20%.

TUKYSA will be used in combination with trastuzumab (Herceptin) and capecitabine in patients who have progressed on at least one HER2 targeting therapy.

“We find the rapid approval impressive, particularly with the challenges of the ongoing COVID pandemic, and is testament to the unmet need in this patient population” cheered Needham analyst Chad Messer on the news.

He also noted that inclusion of brain metastases in the approval label is an important differentiator for the drug. As a result of the rapid approval of TUKYSA, the analyst increased his price target from $144 to $157 (15% upside potential).

Meanwhile Seattle is also expanding the MOUNTAINEER study of tucatinib + Herceptin in colorectal cancer. The study is being expanded to ~110 patients and may support a potential accelerated approval.

Overall, the stock scores a cautiously optimistic Moderate Buy consensus from the Street. However, the average analyst price target of $135 indicates 1.4% downside from the current share price. (See SGEN’s stock analysis on TipRanks).

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