Roche's ADC Combination Receives CHMP Support for First-Line Treatment of Lymphoma
Roche
Oncology Drug Research, Development, and Manufacturing
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.
On March 26, Roche announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of the antibody-drug conjugate (ADC) Polivy (polatuzumab vedotin) in combination with a regimen called R-CHP as a first-line treatment for patients with diffuse large B-cell lymphoma (DLBCL). The press release noted that the combination of Polivy and R-CHP is the first treatment regimen in over 20 years to significantly improve outcomes for this disease.
DLBCL is the most common type of non-Hodgkin lymphoma (NHL), accounting for about one-third of NHL cases. DLBCL is an aggressive type of NHL, with approximately 150,000 people worldwide diagnosed with DLBCL each year. While first-line treatment is often effective, up to 40% of patients experience relapse or develop refractory disease, at which point treatment options are limited, survival times are shorter, and there remains an unmet medical need.
CD79b Protein Specifically Expressed in Most B Cells, Emerging as a Promising Target for New Therapies. Polivy Delivers Anticancer Drugs by Specifically Binding to CD79b on Tumor Cells, Killing These B Cells While Minimizing Harm to Normal Cells. Currently, Polivy Is Approved in Over 60 Countries and Regions Worldwide, Combined with Bendamustine or Rituximab (Rituxan), for the Treatment of Relapsed or Refractory (R/R) DLBCL Patients.
The positive opinion of the CHMP is based on efficacy and safety data from a phase 3 clinical trial. The trial results showed that the Polivy combination therapy significantly improved progression-free survival (HR=0.73; 95% CI: 0.57-0.95; P<0.02) compared with the standard treatment of rituximab + cyclophosphamide + doxorubicin + vincristine + prednisone (R-CHOP). The results of this clinical trial have been published in The New England Journal of Medicine.
Note: The original text has been abridged.
References:
[1] CHMP recommends EU approval of Roche’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma. Retrieved March 25, 2022, from https://www.roche.com/media/releases/med-cor-2022-03-25b
[2] Tilly et al., (2021). Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. NEJM, DOI: 10.1056/NEJMoa2115304
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