Seattle Genetics, Inc. SGEN announced that the FDA has approved its oral tyrosine kinase inhibitor (TKI) Tukysa (tucatinib) in combination with Roche's RHHBY Herceptin (trastuzumab) and Xeloda (capecitabine).
The drug combo is now approved to treat adult patients with locally advanced/metastatic HER2-positive breast cancer including those with brain metastases, having received one or more prior anti-HER2-based regimens in the metastatic setting.
In February 2020, the FDA accepted the new drug application (NDA) for the Tukysa combo to address the given patient population. In December 2019, the NDA application was filed for the same.
We note that the approval comes four months before the scheduled Prescription Drug User Fee Act (PDUFA) action date of Aug 20, 2020. The NDA for Tukysa was also granted a Breakthrough Therapy designation and a priority review under the Real-Time Oncology Review pilot program of the FDA.
The NDA submission was supported by results from the HER2CLIMB study comparing the combo regime of Tukysa plus Herceptin and Xeloda versus Herceptin and Xeloda alone.
Data from the study showed that treatment with the Tukysa combo led to a 46% reduction in the risk of cancer progression or death [progression-free survival (PFS)] compared to patients who received Herceptin and Xeloda alone. Moreover, the addition of Tukysa lowered the risk of death [overall survival (OS)] by 34%.
Per the company, with these highly significant and clinically important outcomes of OS and PFS, the combination of Tukysa plus Herceptin and Xeloda has the potential to become a standard of care for the given patient population.
Shares of Seattle Genetics have rallied 19.8% so far this year compared with the industry’s increase of 2%.
We note that Tukysa is now the third approved product in Seattle Genetics’ portfolio. Notably, last December, the FDA granted accelerated approval to Padcev (enfortumab vedotin-ejfv) for the treatment of patients with advanced/metastatic urothelial cancer, having undergone prior treatment with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy.
The approval of Padcev and Tukysa should reduce Seattle Genetics’ heavy dependence on Adcetris in the days ahead and significantly boost its top-line growth.
Zacks Rank & Stocks to Consider
Seattle Genetics currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Trevena, Inc. TRVN and Celldex Therapeutics, Inc. CLDX, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Trevena’s loss per share estimates have been narrowed 26.4% for 2020 and 23.5% for 2021 over the past 60 days.
Celldex’s loss per share estimates have been narrowed 12.5% for 2020 and 12.9% for 2021 over the past 60 days.
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