FDA grants priority review to Roche’s Lunsumio for Relapsed or Refractory Follicular Lymphoma

Approval is based on results from the pivotal phase-I/II clinical study of Lunsumio

The US Food and Drug Administration (FDA) has accepted and granted priority review to Roche’s Biologics Licence Application (BLA) of Lunsumio (mosunetuzumab) to treat adults with Relapsed or Refractory (R/R) Follicular Lymphoma (FL).

Lunsumio is a CD20xCD3 T-cell engaging bispecific antibody that can be received by patients who have at least two prior systemic therapies, Roche said in a statement.

The approval is based on the submission of positive data from pivotal phase-I/II study. A decision from the FDA on approval for this cancer immunotherapy is anticipated by 29th December, 2022, according to the statement.

According to the results, high Complete Response (CR) rates were observed with most of the responders continuing to have responses for a minimum of 18 months and manageable tolerability in heavily pre-treated FL patients. The CR rate and objective response rate were found to be 60 per cent and 80 per cent, respectively, following a median follow-up of 18.3 months. Furthermore, the median duration of response in subjects who responded was 22.8 months.

Lunsumiopriority reviewRocheUS FDA
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