Takeda Pharmaceutical has secured expanded approval from the European Commission (EC) for its Adcetris in combination with CHP (cyclophosphamide, doxorubicin, prednisone) to treat adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL), a subtype of peripheral T-cell lymphoma (PTCL).
Adcetris (brentuximab vedotin) is an antibody-drug conjugate (ADC) that includes an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent monomethyl auristatin E (MMAE) through Seattle Genetics’ technology.
The ADC deploys a linker system, which is designed to be stable in the bloodstream, as well as release MMAE upon internalisation into CD30-positive tumour cells.
The EC approval was based on data from the phase 3 ECHELON-2 study assessing Adcetris in combination with CHP (cyclophosphamide, doxorubicin, prednisone) to a standard of care, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), in patients with CD30+ PTCL, including the subtype sALCL.
According to the company, the trial achieved its primary endpoint with Adcetris plus CHP showing a statistically significant improvement in progression-free survival (PFS) in the intent to treat the population as evaluated by an Independent Review Committee.
The approval allows to market Adcetris for a new indication in all European Union member states, as well as Norway, Liechtenstein and Iceland.
Adcetris injection for intravenous infusion has secured approval from the US Food and Drug Administration (FDA) for the six indications in adult patients.
Takeda global oncology business unit president Teresa Bitetti said: “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.”
The latest approval from the EC authorises ALUNBRIG to be used as a monotherapy for the treatment of adults having anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC), who did not get any prior treatment with an ALK inhibitor.