Seattle Genetics' Adcetris Gets Breakthrough Therapy Status

Seattle Genetics, Inc.SGEN announced that the FDA has granted Breakthrough Therapy designation to Adcetrisfor the frontline treatment of certain lymphoma subtypes. The designation is granted to treat patients with previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with CHP (cyclophosphamide, doxorubicin, and prednisone).

The Breakthrough Therapy designation is granted to speed up the development and review of drugs that target serious or life-threatening conditions.

The FDA's decision was based on results from the phase III ECHELON-2 study, and the updated results will be presented at the American Society of Hematology Annual Meeting in December this year.

Seattle Genetics along with Takeda announced that the phase III ECHELON-2 study on Adcetris has met its primary endpoint as well as all key secondary endpoints. Adcetris combined with chemotherapy demonstrated a statistically significant improvement in progression-free survival as compared to the control arm. The study also achieved all key secondary endpoints and improved the overall survival in front-line CD30-expressing peripheral T-cell lymphoma (PTCL). The drug is not currently approved for use in case of frontline PTCL.

Seattle Genetics' shares have returned 1.7% so far this year against the industry 's decline of 20.6%.

Adcetris is the only marketed product of Seattle Genetics. The drug is approved for relapsed Hodgkin lymphoma and relapsed systemic anaplastic large cell lymphoma (sALCL) in the United States, EU and Japan. It is also approved in the United States and Europe for the treatment of patients suffering from classical Hodgkin lymphoma (cHL) with no prior treatment and who are at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. It is also approved in combination with chemotherapy for the treatment of stage III or IV classical Hodgkin lymphoma (cHL) in patients with no previous treatment history. It is also approved for primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) in the United States.

Seattle Genetics has an agreement with Takeda Pharmaceutical Company Ltd. for further development and commercialization of Adcetris. Seattle Genetics retains all rights to sell Adcetris in the United States and Canada, while Takeda has commercial rights to the drug in the rest of the world.

However, the drug has several competitors, including Bristol-Myers Squibb's BMY Opdivo and Merck's MRK Keytruda, which are approved for relapsed or refractory cHL.

Seattle Genetics, Inc. Price

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Zacks Rank & Stock to Consider

Seattle Genetics currently carries a Zacks Rank #3 (Hold).

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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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