Entrectinib receives positive decision from EMA
medwireNews: The EMA has recommended granting a conditional marketing authorization to entrectinib for the treatment of solid tumors expressing NTRK gene fusions and non-small-cell lung cancer (NSCLC) positive for ROS1 mutations.
Entrectinib is the second agent, after larotrectinib, to receive a positive decision from the Committee for Medicinal Products for Human on a tumor-agnostic basis.
The multikinase inhibitor is indicated for adult and pediatric patients aged at least 12 years who have no satisfactory treatment options for any NTRK fusion-positive solid tumor that is locally advanced, metastatic, or unresectable, and have not received prior treatment with a TRK inhibitor.
The announcement includes a second indication, namely for adults with advanced NSCLC harboring ROS1 mutations who have not previously received other ROS1 inhibitors.
Entrectinib will be available as hard capsules of 100 or 200 mg.
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