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Roche Announces Positive CHMP Opinion For Gavreto In RET Fusion-positive Advanced NSCLC

Roche (RHHBY) said the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of Gavreto (pralsetinib) as a monotherapy for the treatment of adult patients with rearranged during transfection fusion-positive advanced non-small cell lung cancer not previously treated with a RET inhibitor. The CHMP recommendation is based on the results of the phase I/II ARROW study. A final decision regarding the approval of Gavreto is anticipated in the coming months, the company said.

Blueprint Medicines and Roche are co-developing Gavreto globally, with the exception of certain territories in Asia, including China.

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