FDA accepts the NDA for ensartinib for the treatment of adult patients with metastatic ALK-positive NSCLC
“The FDA’s acceptance of this NDA represents a key milestone for Xcovery in its mission to bring ensartinib as a novel and distinct first-line therapeutic option to ALK-positive NSCLC patients,” said Giovanni Selvaggi, M.D., Chief Medical Officer of Xcovery. “We will continue to work closely with the agency during the review period. This achievement is a testament to our patient-centric vision and has been made possible by the dedication and skills of the entire Xcovery team and stakeholders, with the constant support of the patients, their families and investigators in our clinical trials globally.”
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