EMA CHMP Recommends First All-Oral, Fixed-Duration Ibrutinib plus Venetoclax Regimen for First-Line Treatment of Chronic Lymphocytic Leukemia
Johnson & Johnson
Healthcare Product Manufacturers, Health Service Providers
Janssen Pharmaceuticals
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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.
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News on June 25, 2022 /BioValleyBIOON/ -- Johnson & Johnson (JNJ) subsidiary Janssen Pharmaceuticals recently announced that the European MedicinesManagementThe Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive review opinion, recommending the approval of a new treatment regimen:Imbruvica (Yike, generic name: ibrutinib) in combination with Venclexta/Venclyxto (Weikelai, generic name: venetoclax) as an oral fixed-duration regimen (I+V) for first-line treatment of chronic lymphocytic leukemia.Leukemia(CLL) adult patients.
With the advent of oral therapies targeting the biology of intrinsic diseases, the prognosis for CLL patients has improved over the past decade. This provides an opportunity to combine these new therapies to achieve effective and convenient methods that can produce deep remissions within a limited timeframe. If approved,I+V will be the first all-oral, once-daily, fixed-duration combination regimen using a Bruton's tyrosine kinase (BTK) inhibitor as a first-line treatment for CLL in Europe. Until now, BTK inhibitor-based therapies have not offered this regimen in Europe.
Imbruvica and Venclexta have complementary mechanisms of action.Imbruvica (亿珂®) is an oral Bruton's tyrosine kinase (BTK) inhibitor, co-developed and commercialized by Johnson & Johnson and AbbVie. AbbVie holds the rights for the U.S. market, while Johnson & Johnson holds the rights for markets outside the U.S. Venclexta (唯可来®) is an oral B-cellLymphomaFactor-2 (BCL-2) inhibitor, co-developed and commercialized by AbbVie and Roche. Both parties jointly handle commercialization in the U.S. market (brand name: Venclexta), while AbbVie is responsible for commercialization in markets outside the U.S. (brand name: Venclyxto).In China, these two drugs have been approved, and relevant information can be found on the official websites of Janssen Pharmaceuticals and AbbVie, respectively.
The positive review opinion of the CHMP is based on data from the pivotal Phase 3 GLOW study (NCT03462719). The study showed that, in elderly or medically unfit CLL patients,I+V regimen superior to standard-of-care chemotherapy in primary endpoint of progression-free survival (PFS)ImmunityTreatment regimen chlorambucil + obinutuzumab [C+O] regimen (HR=0.216; 95% CI: 0.131-0.357; p<0.001).
The positive review opinion of the CHMP was also supported by data from the fixed-duration (FD) cohort of the Phase 2 CAPTIVATE study (NCT02910583). The FD cohort evaluated 159 previously untreated (treatment-naive) CLL patients aged ≤70 years, including those with high-risk CLL disease. The results showed,The I+V regimen demonstrated deep and durable remission, with a complete response rate (CR) of 57% and a 3-year survival rate as high as 98%.
The latest data from two studies show that the safety of the I+V regimen is consistent with the known safety profiles of ibrutinib and venetoclax. (Bioon.com)
Source of Original Text:Janssen Receives Positive CHMP Opinion for IMBRUVICA? (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)