THE RUSSIAN COMPANY TAKEDA ANNOUNCED REGISTRATION IN RUSSIA OF A NEW READINGS OF ADCETRIS® PREPARATION (BRENTUKSIMAB VEDOTIN)
Takeda Russia announced the launch of two new indications of Adsetris® on the Russian market:
1) the treatment of previously untreated patients with classical CD30 + Hodgkin’s lymphoma stage IV in combination with doxorubicin, vinblastine and dacarbazine;
2) the treatment of patients with CD30 + T-cell lymphoma of the skin after at least one line of previous systemic therapy.
The targeted drug brentuximab vedotin (BV) is a CD30 conjugate of a directional monoclonal antibody and an antitumor agent monomethylauristatin E (MMAE). Brentuximab vedotin binds to the CD30 receptor on the surface of the tumor cell and, penetrating inside, causes its apoptosis and death.
Adsetris® is available in the form of a lyophilisate for the preparation of a concentrate for the preparation of a solution for intravenous infusions. BV first was registered in Russia on February 26, 2016. for the treatment of patients with recurrent / refractory CD30 + Hodgkin lymphoma after autologous stem cell transplantation and patients with recurrent / refractory systemic anaplastic large cell lymphoma, and since December 26, 2016 it has also been registered for the treatment of patients with CD30 + Hodgkin lymphoma with an increased risk of recurrence or progression of the disease after autologous stem cell transplantation.
The goal of Takeda Company is to contribute to improving the quality of life of patients with the help of the latest achievements in medicine.
Registration on the Russian market of new testimony Adcetris® is a vivid example of the implementation of the course adopted by the company.
This antibody and its introduction into clinical practice provides patients who have exhausted the resources of classical treatment regimens, long-term remission, the possibility of carrying out transplantation of hematopoietic stem cells and gives them a chance for a complete cure.
Hodgkin’s lymphoma (HL) is a malignant tumor disease of the lymphatic system. HL are ill mainly at the age of 18-35 years. In 95% of all cases, there is a CD30 antigen on the surface of HL cells, which is a therapeutic target for BV.
The main task of the first line of therapy for patients with HL is to achieve the maximum number of complete and long-term remissions. Polychemotherapy (PCT) is the standard of treatment for HL in Russia, the USA and Europe, but despite this, 15-30% of patients who received first-line drugs develop relapses of the disease or primary resistance is observed.
The standard component of PCT, bleomycin, leads to pulmonary toxicity in 10% of patients, andmortality among patients with pulmonary toxicity due to bleomycin is observed in 10-20% of patients.
Thus, patients with newly diagnosed HL need more effective and safe therapy.
The results of BV are based on data from a Phase 3 registration study, ECHELON-1, in which patients with previously untreated classical Hodgkin’s lymphoma stage III or IV were included; 664 patients were assigned to the brentuximab group of vedotin, doxorubicin, vinblastine and dacarbazine (A + AVD) and 670 patients to the group of doxorubicin, bleomycin, vinblastine and dacarbazine (ABVD) . The primary endpoint in the study adopted modified progression-free survival (mVBP).
Two-year MBHD in groups A + AVD and ABVD was 82.1% and 77.2% (p = 0.04). The use of the A + AVD regimen by 23% reduced the risk of progression, death or the need for second-line therapy, which reduced the need for high-dose chemotherapy with stem cell autotransplantation by 33%.
The results of ECHELON-1 made it possible to register BV in combination with AVD for the treatment of patients with newly diagnosed HL in the USA and in Europe.