Roche awarded priority review status for Genmab drug rival

After a successful phase II/III study of its drug candidate mosunetuzumab, Roche has applied for marketing authorization from the FDA and been awarded priority review status.

Photo: Michael Buholzer/Reuters/Ritzau Scanpix

Roche’s monoclonal antibody Lunsumio (mosunetuzumab) has taken a big step towards becoming the first approved treatment for non-Hodgkin lymphoma, a form of cancer.

In a press release, Roche reveals the candidate has been awarded priority review status at the FDA, which cuts processing time from ten months to six. A marketing application has been submitted based on a successful pivotal phase II/III study.

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