Amgen, BeiGene's Blincyto gets conditional approval in China to treat blood cancer subtype in children
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China's National Medical Products Administration (NMPA)Â grantedÂ conditional approval to BeiGene (NASDAQ:BGNE) andÂ Amgen's (NASDAQ:AMGN) BlincytoÂ injection to treat children with relapsed or refractory (R/R) CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL).
The NMPA granted conditional approval for adult patients in this indication in December 2020.
BeiGene (BGNE) said the conditional approval ofÂ Blincyto (blinatumomab) was based on ex-China data and interim analysis results of a phase 3 trial of adult patients in China.
The company added that full approval in this indication will depend on the results of a post-marketing study in China.
ALL is a cancer of the blood and bone marrow.