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A secondary analysis suggested that using NGS to identify patients with PTEN loss may be better than IHC in identifying best responders to treatment.
The statement is based on the IMpassion131 trial, in which the combination did not improve survival endpoints compared to paclitaxel in PD-L1-positive patients.
The agency approved the drug for metastatic, RET fusion-positive, non-small cell lung cancer patients who are identified by an FDA-approved test.
The drug giant is discussing the data from Impassion131 with regulators and will use the insights from the trial to inform future studies.
Entrectinib is authorized for advanced NTRK fusion-positive solid tumors with no alternative treatment, and ROS1-positive NSCLC patients.
The approval is based on the results from the Phase III IMspire150 study, in which patients treated with the three-drug combination had an improvement in progression-free survival.
Over the last six months the agency approved 21 cancer treatments for molecularly defined indications compared to 12 during the same period last year and 20 during all of 2019.
Healthcare professionals can inject the regimen, containing Perjeta, Herceptin, and hyaluronidase, in patients' homes after intravenous chemotherapy.
The agency based its decision on a trial showing that patients receiving the combo had a median PFS of 19.4 months versus 12.4 months for those on Tarceva.
However, the translational biomarker analysis suggested that high HER2 expression after neoadjuvant treatment may signal resistance to adjuvant Herceptin.