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Seattle Genetics (SGEN) Filed Supplemental BLA for Adcetris - Analyst Blog

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Seattle Genetics, Inc. ( SGEN ) announced the submission of a supplemental biologics license application (BLA) to the FDA for Adcetris as consolidation therapy immediately following an autologous stem cell transplant (ASCT) in patients suffering from Hodgkin lymphoma, who are at a high risk of relapse.

The company submitted the BLA on the basis of positive data from the phase III AETHERA study.

We note that Adcetris is already approved for intravenous injection in the U.S. (accelerated approval) and the EU (conditional marketing authorization) for the treatment of patients with Hodgkin lymphoma after the failure of ASCT or at least two previous multi-agent chemotherapy regimens in patients who have not undergone ASCT.

The drug also received accelerated approval for systemic anaplastic large cell lymphoma (sALCL) after the failure of at least one prior multi-agent chemotherapy regimen in the U.S. and conditional marketing authorization for relapsed or refractory sALCL in the EU.

Adcetris is being developed by Seattle Genetics in partnership with Takeda Pharmaceutical ( TKPYY ). According to the agreement, Seattle Genetics holds the commercialization rights to Adcetris in the U.S. and Canada, while Takeda has the rights in the rest of the world. Both companies share development costs for Adcetris equally, except in Japan where Takeda bears the entire costs of development.

Apart from the AETHERA study, both companies are evaluating Adcetris in three phase III studies - ALCANZA (relapsed cutaneous T-cell lymphoma), ECHELON-1 (front-line advanced classical Hodgkin lymphoma) and ECHELON-2 (front-line mature T-cell lymphoma including sALCL). Data from the ALCANZA study should be out in 2016.

Meanwhile, Seattle Genetics is also working on developing its pipeline beyond Adcetris. The company has several early-stage candidates in its pipeline including six antibody drug conjugates - SGN-CD19A, SGN-CD33A, SGN-LIV1A, SGN-CD70A, ASG-22ME and ASG-15ME. Earlier this week, Seattle Genetics initiated a phase I study on its investigational immuno-oncology agent, SEA-CD40, for multiple types of advanced solid tumors.

Seattle Genetics carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are BioMarin Pharmaceutical Inc. ( BMRN ) and Cytokinetics, Inc ( CYTK ). While Cytokinetics carries a Zacks Rank #1 (Strong Buy), BioMarin holds a Zacks Rank #2 (Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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