Seattle Genetics, Inc. (SGEN - Free Report) announced that the FDA has granted Breakthrough Therapy Designation status to its lymphoma drug, Adcetris, as frontline treatment for advanced classical Hodgkin lymphoma. The company recently completed a phase III study – ECHELON-1 – on the drug for this indication.
We remind investors that Adcetris is currently approved as second or third-line treatment for classical Hodgkin lymphoma and systemic anaplastic large cell lymphoma after at least one failed multi-agent chemotherapy regimen in the United States as well as Europe.
The Breakthrough Therapy designation was granted to speed up the development and review of drugs that target serious or life-threatening conditions.
The company’s shares closed 7.9% higher on Monday, following the news. Shares of Seattle Genetics have risen 11.3% so far this year, underperforming the industry’s gain of 15.4% in that period.
In June 2017, the company announced positive top-line data from the ECHELON-1 study, which demonstrated that Adcetris achieved improvement in modified progression-free survival of statistical significance compared to standard of care chemotherapy. The ECHELON-1 study evaluated Adcetris in addition to Adriamycin, vinblastine and dacarbazine in patients with advanced classical Hodgkin lymphoma with no prior treatment. The designation was granted based on the above data.
The company expects to submit a supplemental biologics license application (“sBLA”) by the end of 2017.
Seattle Genetics is developing the drug in more than 70 clinical studies with key studies including evaluation in T-cell lymphomas and Hodgkin lymphoma. The company has completed ALCANZA phase III study and submitted a sBLA last month to expand its label to include cutaneous T-cell lymphoma. A decision is expected in December 2017. Another phase III study is currently evaluating Adcetris in frontline mature T-cell lymphomas and a recently initiated study is evaluating the drug in combination with Bristol-Myers Squibb Company’s (BMY - Free Report) Opdivo in relapsed/refractory Hodgkin lymphoma.
Adcetris is the only marketed product of Seattle Genetics and generated sales of $144.7 million in the first half of 2017, up almost 16% from the year-ago period. Further label expansion in new indications should boost the sales numbers.
However, Adcetris faces competition from other drugs, which include Merck & Co., Inc.’s (MRK - Free Report) Keytruda that was recently approved in the lymphoma indication.
Zacks Rank & Stock to Consider
Seattle Genetics carries a Zacks Rank #3 (Hold). Regeneron Pharmaceuticals, Inc. (REGN - Free Report) is a better-ranked stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings per share estimates have increased from $13.84 to $14.99 for 2017 and from $15.79 to $16.65 for 2018 over the last 60 days. The company pulled off positive earnings surprises in two of the trailing four quarters, with an average beat of 10.11%. The share price of the company has increased 25.9% year to date.
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