EMA Recommends EU Conditional Approval of Roche’s Mosunetuzumab

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EMA is recommending EU conditional approval of Roche’s potential first-in-class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma.

Roche announced on April 22, 2022 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval under conditional marketing authorization for mosunetuzumab. The drug is meant for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies.

According to a press release, more than 28,000 people in Europe are diagnosed with FL each year. FL is the second most common form of lymphoma globally, accounting for 20% of all non-Hodgkin lymphomas (NHL) diagnosed worldwide. The majority of people with FL relapse within five years after initial treatment, and conventional treatment options are currently limited for those who have received two or more prior therapies.

If approved, mosunetuzumab will be a first-in-class CD20xCD3 T-cell engaging bispecific antibody in NHL. A final decision regarding the conditional approval of the treatment is expected from the European Commission in the near future.


“The majority of people with follicular lymphoma experience frequent relapses, and with each successive therapy the duration of remission and survival shortens,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development, in a press release. “Today’s decision acknowledges the potential of mosunetuzumab as an efficacious, readily available, fixed-duration option, and brings the possibility of new hope to people living with this disease.”

Source: Roche