Zai Lab Limited (ZLAB) Monday said China's National Medical Products Administration (NMPA) has accepted the supplemental New Drug Application (sNDA) for repotrectinib for the treatment of adults with solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
In June last year, the drug was approved by the U.S. Food and Drug Administration (FDA) to treat patients aged 12 years and older with solid tumors that have a NTRK gene fusion. Repotrectinib is also approved by the FDA as well as NMPA for the treatment non-small-cell lung cancer.
Zai Lab has an exclusive license agreement with Turning Point Therapeutics, Inc.,a Bristol Myers Squibb company, to develop and sell repotrectinib in Greater China.
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