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 … Continue reading →