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Yesterday, Baekje announced that the European Commissioner's European Medicines Agency (EMA) Committee on Pharmaceuticals for Human Use (CHMP) has issued its positive opinion recommending Beyondt ® (zebutinib) for marketing authorization, recommending approval ® for the treatment of adults with
marginal zone lymphoma (MZL) who have previously undergone at least one anti-CD20 therapy.
Approved ® for the treatment of adults with
marginal zone lymphoma (MZL) who have previously received at least one anti-CD20 therapy.
Adult patients with
Fahrenheit macroglobulinemia (WM).
NICE's decision marks the ® first and only conventional drug
recommended for WM in England and Wales.
WM is a rare B-cell lymphoma that makes up only 2%
of non-Hodgkin lymphoma patient population.
Dr Shirley D'Sa, Consultant and Clinical Leader of the Hematology Department at the WM and Related Diseases Centre at University College London, said: "Beaux-Centro ® is a highly selective BTK inhibitor
.
In this assessment, NICE believes that Baiyueze ® can be seen as a "significant advance"
in WM treatment.
Dr Robert Mulrooney, General Manager of BeiGene, UK and Ireland, said: "I am delighted that NICE has listed NICE ® as an important treatment option for WM patients in England and Wales who meet the treatment standards, which will make WM patients in these regions the first people
in Europe to be able to use Beaux.
About Fahrenheit macroglobulinemia
About Fahrenheit macroglobulinemia Fahrenheit macroglobulinemia (WM) is a rare B-cell lymphoma that accounts for only 2%
of non-Hodgkin lymphoma patients.