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Home Takeda Receives Positive CHMP Opinion for ADCETRIS® (brentuximab vedotin) in Combination with CHP for First-Line Treatment of CD30-Positive Systemic Anaplastic Large Cell Lymphoma

Takeda Receives Positive CHMP Opinion for ADCETRIS® (brentuximab vedotin) in Combination with CHP for First-Line Treatment of CD30-Positive Systemic Anaplastic Large Cell Lymphoma

Apr 07, 2020 17:39 CST Updated 17:39
Takeda

Biopharmaceutical Manufacturer

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.

European Medicines Agency

The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.


April 07, 2020 News /BioValleyBIOON/ -- Takeda Pharmaceutical Company Limited (Takeda) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the expansion of the marketing authorization for Adcetris (brentuximab vedotin) to include: first-line treatment in combination with the CHP chemotherapy regimen (cyclophosphamide + doxorubicin + prednisone).TumorAdult patients with CD30-positive (CD30+) systemic anaplastic large cell lymphoma (sALCL). The CHMP opinion will now be submitted to the European Commission (EC) for review, which typically issues a final decision within two months.

Adcetris is an antibody-drug conjugate (ADC) targeting CD30, which is expressed on the surface of various peripheral T-cell lymphoma (PTCL) cells, including systemic anaplastic large cell lymphoma (sALCL). Currently, Adcetris has not been approved in Europe for first-line treatment of sALCL.

The CHMP’s positive opinion is based on data from the Phase III ECHELON-2 clinical study. This is the largest randomized, double-blind Phase III study conducted to date in patients with peripheral T-cell lymphoma (PTCL), enrolling previously untreated CD30-positive PTCL patients (with a target proportion of systemic anaplastic large cell lymphoma [sALCL] of 75% ± 5%). The study evaluated the efficacy and safety of Adcetris in combination with the CHP chemotherapy regimen (cyclophosphamide, doxorubicin, and prednisone) as first-line treatment, compared with the currently accepted standard-of-care first-line regimen for PTCL, CHOP (cyclophosphamide, doxorubicin [an anthracycline], vincristine, and prednisone). The primary endpoint was progression-free survival (PFS) as assessed by an independent review facility (IRF).

The results demonstrated that, compared with the CHOP regimen, the Adcetris+CHP regimen achieved a statistically significant improvement in progression-free survival (PFS), thereby meeting the primary endpoint of the study (median PFS: 48.2 months [95% CI: 35.2–NE] vs. 20.8 months [95% CI: 12.7–47.6]; IRF-assessed HR=0.71 [95% CI: 0.54–0.93], p=0.0110). Furthermore, compared with the CHOP regimen, the Adcetris+CHP regimen also showed a statistically significant improvement in the key secondary endpoint of overall survival (OS) (HR=0.66, p=0.0244), with the median OS not yet reached in either group at the time of analysis. The Adcetris+CHP regimen also demonstrated statistically significant advantages in other key secondary endpoints, including PFS in patients with systemic anaplastic large cell lymphoma (sALCL), complete response rate (CRR: 68% vs. 56%, p=0.007), and objective response rate (ORR: 83% vs. 72%, p=0.003). In this study, the safety profile of the Adcetris+CHP regimen was comparable to that of the CHOP regimen and consistent with the established safety profile of Adcetris in combination with chemotherapy.

Adcetris is an antibody-drug conjugate (ADC) composed of a monoclonal antibody targeting the CD30 protein and a microtubule-disrupting agent (monomethyl auristatin E, MMAE) linked via a protease-sensitive linker. This conjugation technology was developed by SeattleGeneticsthe company’s proprietary technology. The CD30 protein is a well-established marker for classical Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL), while Auristatin E impedes cell division by inhibiting tubulin polymerization. Adcetris remains stable in the bloodstream and, upon binding to CD30-positiveTumorFollowing internalization into cells, MMAE can be released.

Adcetris by SeattleHeredityDeveloped by Seattle Genetics, Takeda entered into a licensing agreement in 2009 to secure commercialization rights for the drug in all countries worldwide except the United States and Canada. To date, Adcetris has been approved in more than 70 countries globally for the treatment of relapsed or refractory Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). In the United States, Adcetris has receivedFDAApproved for 6 adult indications.

Currently, Takeda and SeattleGeneticsTakeda is actively advancing a large-scale Phase III clinical development program aimed at establishing Adcetris as a cornerstone therapy for CD30-positive lymphomas and redefining first-line clinical treatment for lymphoma. (Bioon.com)