Seattle Genetics Receives European Commission Approval for Lymphoma Drug, Expected to Boost Sales

On Monday (January 22), Seattle Genetics (NASDAQ:SGEN) announced that it had received European Commission approval for its CD30-positive cutaneous T-cell lymphoma, which could help bolster its share price into the next quarter.
According to the press release, the European Commission has extended the current conditional marketing authorization for the company’s partner, Takeda Pharmaceutical (TYO:4502), for its lymphoma drug, Adcetris. This will allow the marketing authorization to be extended for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma after one prior systemic therapy. Essentially what this means is patients who have been treated for Hodgkin lymphoma and relapsed systemic anaplastic large cell lymphoma–as well as patients suffering from classical Hodgkin lymphoma–have a higher risk of relapse and are therefore able to use Adcetris.
In short, this news is big for Seattle Genetics because it’s their only marketed product.

Clay Siegall, the company’s president and CEO, said CTCL is a “debilitating and disfiguring disease” with limited treatment options.
“The approval of ADCETRIS for use in the European Union in CD30-positive CTCL patients represents a meaningful advance for patients with CTCL,” Siegall said. “We are pleased that our partner Takeda is able to make this therapeutic option available to patients in Europe.”
In November of last year, the FDA approved Adcetric for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma and CD30-expressing mycosis fungoides for patients whom received prior systemic therapy. This approval was based on data from the phase 3 Alcanza trial and two phase 2 investigator-sponsored trials, also the fourth FDA-approved indication for the drug.
“Sales of the drug in the third quarter grew 13 percent year over year to $79.2 million,” Zacks Analyst Equity Research commented regarding the news. “The label expansion is expected to boost the sales of the drug further.” The EU commission gives marketing authorization to 28 countries in the EU for Adcetris.

Investor Takeaway

In terms of its share price, Seattle Genetics’ stock price took an 8.6 percent last year. as the industry increased 5.8 percent. Since the announcement earlier this week, however, Seattle Genetics’ stock has responded positively, rising 3.95 percent to close at $55.59 on Thursday (January 24). While the company holds a hold rating on Zacks, TipRanks shows three buy and six hold ratings and predicts a high of $75.00 for the next year.
That said, however, the company’s Adcetris product could face competition from other drugs. For example, Merck & Co. (NYSE:MRK) is developing Keytruda, which also received FDA approval for lymphoma indication.
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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.