The approval is based on results of from Phase 3 ECHELON-2 trial, which showed that treatment with ADCETRIS plus CHP improved progression-free survival in patients
Takeda Pharmaceutical Company global headquarters in Tokyo. (Credit: 妖精書士/Wikipedia)
Japan-based pharmaceutical company Takeda has obtained the extended European Commission (EC) the marketing authorisation for ADCETRIS (brentuximab vedotin) in combination with cyclophosphamide, doxorubicin, prednisone (CHP).
The European regulatory approval has extended the indication to include treatment of previously untreated systemic anaplastic large cell lymphoma (sALCL), a subtype of peripheral T-cell lymphoma (PTCL).
The current extended EC approval follows a positive opinion from the committee for medicinal products for human use (CHMP) on 27 March 2020.
Takeda global oncology business unit president Teresa Bitetti 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.”
EC approval allows marketing of ADCETRIS in EU, Norway, Liechtenstein and Iceland
ADCETRIS is an antibody-drug conjugate (ADC) the contains an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), using Seattle Genetics’ technology.
The ADC is said to employ a linker system that has been designed to remain stable in the bloodstream but release the MMAE after being internalised into CD30-positive tumour cells.
The regulatory approval is supported by the results from Phase 3 ECHELON-2 trial evaluating ADCETRIS plus CHP, compared to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP), in patients with CD30+ PTCL, including the subtype sALCL.
The study reached its primary endpoint of ADCETRIS plus CHP showing improvement in progression-free survival (PFS) to treat the population as assessed by an independent review committee.
In the ECHELON-2 trial, ADCETRIS plus CHP has shown a safety profile comparable to CHOP and consistent with the established safety profile of ADCETRIS in combination with chemotherapy.
Takeda said that the EC approval allows marketing of ADCETRIS with the current indication in all European Union member states, in addition to Norway, Liechtenstein and Iceland