Seagen Inc. ( SGEN Quick Quote SGEN - Free Report) announced that the European Commission (“EC”) has granted marketing authorization to its oral tyrosine kinase inhibitor (“TKI”) Tukysa (tucatinib) in combination with Roche's ( RHHBY Quick Quote RHHBY - Free Report) Herceptin (trastuzumab) and Xeloda (capecitabine). The drug combo is now approved for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer, and who have received at least two prior anti-HER2 treatment regimens.
The EU approval was expected, as in December 2020, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the approval of Tukysa combo for the given indication.
The EC approval was based on data from the pivotal HER2CLIMB study comparing the combination regime of Tukysa plus Herceptin and Xeloda versus Herceptin and Xeloda alone. Data from the same showed that treatment with the Tukysa combo led to a 46% reduction in the risk of cancer progression or death (progression-free survival), the study’s primary endpoint compared to patients who received Herceptin and Xeloda alone. The Tukysa combo also improved overall survival with a 34% reduction in the risk of death.
Per the company, following the nod in Europe, Tukysa became the first HER-2 TKI combination regimen to improve overall and progression-free survival in previously treated patients with metastatic HER2-positive breast cancer regardless of brain metastases.
Shares of Seagen have declined 5.3% year to date against the
industry’s increase of 12.1%. Notably, in April 2020, the FDA approved the same Tukysa combo 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 fourth quarter of 2020, Tukysa’s generated sales worth $61.4 million, increasing 44.8% sequentially. The nod in Europe should boost the drug’s sales in 2021
In a separate press release, Seagen announced primary results from the phase III EV-301 study which is comparing Padcev to chemotherapy for treating locally advanced/metastatic urothelial cancer in adult patients having previously been treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.
Data from the study showed that patients who were treated with Padcev lived a median of 3.9 months longer than those who received chemotherapy, while median overall survival was 12.9 months as compared to 9 months in the chemotherapy arm.
Data from the EV-301 study will support global registrations for Padcev to address the given indication.
Zacks Rank & Stocks to Consider
Seagen currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include
Acorda Therapeutics, Inc. ( ACOR Quick Quote ACOR - Free Report) and Vericel Corporation ( VCEL Quick Quote VCEL - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Acorda’s loss per share estimates have narrowed 23.6% for 2021 over the past 60 days. The stock has skyrocketed 81.9% year to date.
Vericel’s earnings estimates have been revised 11.7% upward for 2021 over the past 60 days. The stock has rallied 64.1% year to date.
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