Roche's First-in-Class CD20/CD3 Bispecific Antibody Mosunetuzumab Receives CHMP Positive Opinion for Relapsed or Refractory Follicular 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.
Today, Roche announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the conditional approval of mosunetuzumab, a bispecific antibody targeting CD20 and CD3, for the treatment of relapsed or refractory follicular lymphoma. These patients have previously received two prior lines of therapy. The press release noted that if approved, mosunetuzumab will become the first CD20/CD3 T-cell engaging bispecific antibody to treat this patient population, offering a ready-to-use new treatment option.
Follicular lymphoma is the second most common lymphoma globally, accounting for 20% of all non-Hodgkin lymphomas. It is considered incurable, and disease recurrence is common. Mosunetuzumab is a bispecific T-cell engager antibody targeting CD20 and CD3, which can activate patients' existing T cells and direct them to attack B cells. It has been granted Breakthrough Therapy Designation by the U.S. FDA for treating follicular lymphoma patients who have received at least two prior systemic therapies.
CHMP's recommendation is based on the positive results of the phase 1/2 clinical trial GO29781. The trial results showed that, with a median follow-up time of 18.3 months, the complete response rate reached 60% (n=54/90), the objective response rate was 80% (n=72/90), the median progression-free survival was 17.9 months, and the median duration of response was 22.8 months. These results were presented in December last year at the annual meeting of the American Society of Hematology (ASH).
"Most patients with follicular lymphoma will experience multiple relapses, and after each relapse, the remission and survival periods achieved by subsequent treatments will become shorter," said Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche. "Today's decision is a recognition of mosunetuzumab as a ready-to-use, effective treatment option that may bring new hope to patients."
References:
[1] CHMP recommends EU conditional approval of Roche’s potential first-in-class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma. Retrieved April 22, 2022, from https://www.globenewswire.com/news-release/2022/04/22/2427504/0/en/CHMP-recommends-EU-conditional-approval-of-Roche-s-potential-first-in-class-bispecific-antibody-mosunetuzumab-for-people-with-relapsed-or-refractory-follicular-lymphoma.html
*Disclaimer: This article was written by an author who contributes to Sina Medicine News. The views expressed in this article are those of the author and do not represent the position of Sina Medicine News.▽Follow 【WuXi AppTecGermany】WeChat Official Account
