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SGEN's Adcetris under FDA Review

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Seattle Genetics, Inc. (SGEN - Free Report) recently announced that the US Food and Drug Administration (FDA) has accepted its supplemental biologics license application (sBLA) seeking approval of Adcetris (brentuximab vedotin) for an additional indication. The company is looking to get Adcetris approved for retreatment and extended duration of medication with the drug beyond 16 cycles in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL).

We remind investors that Seattle Genetics submitted the sBLA to the FDA in Mar 2013 on the basis of encouraging data from a phase II study. The study had two treatment arms. One arm evaluated retreatment with Adcetris in patients who had responded to Adcetris treatment earlier, then discontinued treatment and as a result suffered disease progression or relapse. The other arm evaluated prolonged treatment with Adcetris beyond 16 cycles of medication. 70% of patients retreated with Adcetris and 88% of patients with extended treatment with Adcetris achieved an objective response. In both the settings, Adcetris was well tolerated. A final decision from the FDA is expected by Sep 14, 2013 (action date).

We note that Adcetris was approved by the FDA in Aug 2011 for the treatment of patients with HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not suitable for ASCT. Adcetris was also approved for sALCL in treatment-experienced patients.

We are positive on Seattle Genetics’ efforts to expand Adcetris’ label. Successful label expansion should boost the sales potential of the drug. Adcetris’ net product revenue in the first quarter of 2013 was $33.9 million. Adcetris is also being evaluated in other indications.

Seattle Genetics carries a Zacks Rank #2 (Buy). Right now, Alkermes plc (ALKS - Free Report) and Anika Therapeutics Inc. (ANIK - Free Report) look more attractive with a Zacks Rank #1 (Strong Buy). Myriad Genetics Inc. (MYGN - Free Report) also carries Zacks Rank #2.

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