Seattle Genetics, Inc. SGEN announced that the FDA has accepted its supplemental Biologics License Application (BLA) for Adcetris for priority review for as consolidation therapy immediately following an autologous stem cell transplant (ASCT) in patients suffering from Hodgkin's lymphoma, who are at high risk of relapse or progression.
Adcetris is already approved for the treatment of relapsed Hodgkin's lymphoma and systemic anaplastic large cell lymphoma. Currently, Seattle Genetics is looking to expand Adcetris’ label in the post-transplant setting for consolidation therapy in Hodgkin's lymphoma patients.
The FDA accepted the BLA on the basis of positive data from the phase III AETHERA study. An action from the FDA is expected by Aug 18, 2015.
According to the American Cancer Society, approximately 9,050 patients are expected to be diagnosed with Hodgkin lymphoma in the U.S. through 2015, with more than 1,150 patients expected to die from the disease. Seattle Genetics believes that up to 30% of Hodgkin's lymphoma patients treated with front-line therapy relapse or are refractory to the treatment.
Moreover, nearly half of all these patients, who undergo an ASCT, experience disease relapse. Hence, there is a solid scope for Adcetris to gain a large share in this market, if approved as consolidation therapy immediately following an ASCT.
We note that Adcetris is the only marketed product at Seattle Genetics. Upon label expansion, the drug should be able to support the company’s top line further, thereby strengthening its growth trajectory.
Meanwhile, Seattle Genetics and Bristol-Myers Squibb Company BMY intend to evaluate Adcetris in combination with the latter’s Opdivo in two phase I/II studies as a potential treatment option for relapsed or refractory Hodgkin lymphoma and relapsed or refractory B-cell and T-cell non-Hodgkin lymphomas including DLBCL. The studies are expected to begin in 2015.
Seattle Genetics carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Shire plc SHPG and Horizon Pharma plc HZNP. Both carry a Zacks Rank #1 (Strong Buy).
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