Takeda gets extended EC approval for ADCETRIS in sALCL

Takeda Pharmaceutical has secured extended approval for ADCETRIS (brentuximab vedotin) in the European Union to include the treatment of previously untreated systemic anaplastic large cell lymphoma (sALCL) in adult patients.

The approval from the European Commission (EC) is for the combination of ADCETRIS with CHP (cyclophosphamide, doxorubicin, prednisone. It comes in the wake of a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) in late March.

Systemic anaplastic large cell lymphoma is a subtype of peripheral T-cell lymphoma (PTCL).

ADCETRIS is an antibody-drug conjugate (ADC) made up of an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent called monomethyl auristatin E (MMAE) by using Seattle Genetics’ technology. The antibody-drug conjugate uses a linker system designed to be stable in the bloodstream but to release MMAE after internalization into CD30-positive tumor cells.

ADCETRIS was granted conditional marketing authorization in October 2012 by the European Commission. The previously approved indications in the European Union for the ADC either as a monotherapy or as a combination therapy include Hodgkin lymphoma, T-cell lymphoma, and for the treatment of adults having relapsed or refractory systemic anaplastic large cell lymphoma.

Takeda gets EC approval for ADCETRIS in previously untreated systemic anaplastic large cell lymphoma. Photo courtesy of Business Wire.

The latest extended approval in systemic anaplastic large cell lymphoma has been driven by the data from the phase 3 ECHELON-2 clinical trial, which assessed ADCETRIS in combination with CHP to a standard of care, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), in patients having CD30+ PTCL, including the subtype sALCL.

The ECHELON-2 clinical trial met its primary endpoint with ADCETRIS in combination with CHP delivering a statistically significant improvement in progression-free survival (PFS) in the intent to treat patient population as assessed by an Independent Review Committee.

Teresa Bitetti – President of Takeda Pharmaceutical Global Oncology Business Unit said: “The European Commission’s decision to approve ADCETRIS for the first-line treatment of patients with sALCL marks a significant milestone for people diagnosed with this devastating condition.

“ADCETRIS is the first and only targeted therapy that has been approved in first-line sALCL in several decades. Takeda remains steadfast in our commitment to deliver life changing treatment options to cancer patients worldwide and we are thrilled to have the opportunity to bring this new option to the lymphoma community in Europe.”

ADCETRIS is being jointly developed by Seattle Genetics and Takeda Pharmaceutical. As per the collaboration terms, Seattle Genetics holds the US and Canadian commercialization rights, while the Japanese pharma company has rights to commercialize the ADC in the rest of the world.