Roche’s Lung Cancer Drug Pralsetinib Gets FDA Regular Approval

Roche Group’s Genentech gets FDA regular approval for Pralsetinib (Gavreto) for adult patients with metastatic rearranged during transfection fusion-positive non-small cell lung cancer.

• Previously granted accelerated approval for the non-small cell lung cancer indication in 2020
• Conversion to regular approval was based on data from an additional 123 patients and 25 months of additional follow-up to assess durability of response
• NOTE: In Sept. 2020, Roche Says U.S. FDA Has Approved Gavreto for Lung Cancer

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