Takeda’s Adcetris recommended for European lymphoma approval

Takeda has announced that its cancer therapy Adcetris has been recommended for European approval as a treatment for another form of lymphoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the extension of Adcetris’ marketing authorisation to include the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

Adcetris is an antibody-drug conjugate targeting CD30, which is expressed on skin lesions in approximately 50 percent of patients with this disease.

The recommendation was based on positive data from the phase III ALCANZA study, which showed that Adcetris was associated with a significant improvement in response rates, progression-free survival and symptom burden.

Dr Jesus Gomez Navarro, vice-president and head of oncology clinical research and development at Takeda, said: “For patients with CTCL, there is a significant need for additional treatment options that increase the opportunity to achieve durable responses.”

Tasigna was first approved in the EU in 2007 and earlier this year, Tasigna received European Commission (EC) approval for inclusion of Treatment-free Remission data in the EU product label. With this EC approval, Tasigna became the first and only TKI to include information on stopping therapy in adult patients with Ph+ CML-CP in both the first-line setting and after switching from imatinib in the EU label.

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