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SGEN Seeks Adcetris Label Expansion

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Seattle Genetics, Inc. (SGEN - Free Report) recently announced the submission of a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) for the use of Adcetris (brentuximab vedotin) in the retreatment of patients and for extended duration of use beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL).

The sBLA was based on results 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 therapy.

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. In Oct 2012, Adcetris gained EU approval as well for the same indications.

In Jan 2013, a global phase III study (ECHELON-2) was initiated on Adcetris. In this study, Adcetris plus chemotherapy will be evaluated for the front-line treatment of CD30-positive mature T-cell lymphoma (MTCL) including patients with sALCL and other types of peripheral T-cell lymphomas.

In Feb 2013, Adcetris received approval under Health Canada's Notice of Compliance with conditions (NOC/c) for the treatment of relapsed or refractory HL and sALCL.

Our Take

We are positive on Seattle Genetics’ efforts to expand Adcetris’ label. Adcetris’ net product revenue in the fourth quarter of 2012 was $35.4 million.

Seattle Genetics carries a Zacks Rank #3 (Hold). Right now, Cytokinetics, Inc. (CYTK - Free Report) , Osiris Therapeutics, Inc. , and XOMA Corporation (XOMA - Free Report) look more attractive with a Zacks Rank #1 (Strong Buy).

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