Takeda Pharmaceutical Company Limited
) 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
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.
) 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).
Lannett Company, Inc.
) look better-positioned than Takeda. They both carry a Zacks
Rank #1 (Strong Buy).
CYTOKINETCS INC (CYTK): Free Stock Analysis
LANNETT INC (LCI): Free Stock Analysis Report
SEATTLE GENETIC (SGEN): Free Stock Analysis
TAKEDA PHARMACT (TKPYY): Get Free Report
To read this article on Zacks.com click here.