Takeda Pharmaceutical Company Limited ( TKPYY ) and its subsidiary, Millennium, recently announced the submission of a new drug application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for Adcetris (brentuximab vedotin).
Takeda is looking to get Adcetris approved in Japan for the treatment of adults suffering from relapsed or refractory CD30 positive Hodgkin lymphoma (HL) and relapsed or refractory CD30 positive anaplastic large cell lymphoma (ALCL).
The regulatory application was based on results from a pivotal phase I/II study that evaluated the safety, tolerability and efficacy of Adcetris in patients suffering from relapsed or refractory CD30 positive HL and relapsed or refractory CD30 positive systemic ALCL. The company's submission also included data from two global pivotal phase II studies.
We note that Adcetris enjoys orphan drug status in Japan for HL and ALCL.
Adcetris has been jointly developed by Seattle Genetics Inc. ( SGEN ) and Millennium. Adcetris is currently approved in both the US and the EU.
Adcetris is approved in the US for the treatment of patients infected with HL after unsuccessful autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in non-ASCT patients and also for the treatment of patients with sALCL after failure of at least one multi-agent chemotherapy regimen.
Seattle Genetics recently submitted a supplemental Biologics License Application (sBLA) seeking FDA approval for Adcetris for retreatment and extended duration beyond 16 cycles of therapy in relapsed HL and sALCL patients.
In the EU, Adcetris received conditional marketing authorization for the treatment of adults with relapsed or refractory CD 30+HL after ASCT or after a minimum of two prior therapies when ASCT or multi-agent chemotherapy is inappropriate. It is also approved for the treatment of relapsed or refractory sALCL in adults.
Currently, Takeda carries a Zacks Rank #4 (Sell). Comparatively, Lannett Company, Inc. ( LCI ) and Cytokinetics, Inc. ( CYTK ) look better-positioned than Takeda. They both carry a Zacks Rank #1 (Strong Buy).