The personalised cancer treatment has received conditional approval in the US - News - PharmaTimes
US regulators have approved Genentech's Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC).
The indication was approved under the FDA's accelerated approval programme based on data from the Phase I/II ARROW study, and so continued clearance may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations.
According to the firm, in the Phase I/II ARROW study Gavreto produced “durable clinical responses” in people with RET fusion-positive NSCLC with or without prior therapy, and regardless of RET fusion partner or central nervous system involvement.
Read more: http://www.pharmatimes.com/news/genentechs_gavreto_cleared_for_ret_non-small_cell_lung_cancer_1348772
The indication was approved under the FDA's accelerated approval programme based on data from the Phase I/II ARROW study, and so continued clearance may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations.
According to the firm, in the Phase I/II ARROW study Gavreto produced “durable clinical responses” in people with RET fusion-positive NSCLC with or without prior therapy, and regardless of RET fusion partner or central nervous system involvement.
Read more: http://www.pharmatimes.com/news/genentechs_gavreto_cleared_for_ret_non-small_cell_lung_cancer_1348772
