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Seagen (SGEN) Gets Positive CHMP Opinion for Breast Cancer Drug

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Seagen Inc. (SGEN - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the approval of Tukysa (tucatinib) in combination with Roche AG’s (RHHBY - Free Report) Herceptin (trastuzumab) and Xeloda (capecitabine) for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer, who have received at least two prior anti-HER2 treatment regimens.

Shares of Seagen have surged 67.3% year to date compared with the industry’s growth of 8.1%.

The positive CHMP opinion is supported by results of the pivotal HER2CLIMB study, comparing the combination 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%.

The CHMP positive opinion will now be considered by the European Commission (EC), which has the authority to approve medicines in the European Union (EU). 

We note that Tukysain combination with Herceptin and Xeloda is approved in the United States 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.

An approval will boost sales for the company.


Zacks Rank & Stocks to Consider

Seagen currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the healthcare sector include Aerpio Pharmaceuticals Ltd. (ARPO - Free Report) and Aptose Biosciences Inc. (APTO - Free Report) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Aerpio’s loss per share estimates have narrowed from 15 cents to 14 cents for 2020 and from 63 cents to 57 cents for 2021 over the past 60 days.

Aptose’s loss per share estimates have narrowed from 77 cents to 69 cents for 2020 and from 85 cents to 81 cents for 2021 over the past 60 days.

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