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news.China’s Food and Drug Administration (CFDA) has accepted for review CASI Pharmaceuticals' import drug registration application for MARQIBO (vinCRIStine sulfate LIPOSOME injection).
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CASI’s China rights to MARQIBO was licensed from its partner Spectrum Pharmaceuticals, Inc. MARQIBO is the first and only liposome-encapsulated vincristine approved and currently marketed in the U.S. for second line treatment of adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL).
CASI’s filing with the CFDA is an important milestone step to expand the availability of the treatment to patients in China. Annual incidence of leukemia in China is estimated at 70,240 cases with a mortality of 58,746 cases in 2015.
The five-year prevalence in the country is estimated at 73,694 cases including about 10,000 Ph- adult ALL, representing a serious, unmet medical need.
CASI CEO Ken Ren said: "We are very pleased with CFDA’s decision and look forward to working with the agency to move the process forward towards market approval. As part of the market approval process, we expect to conduct a confirmatory trial in China.
"MARQIBO is also being developed in two Phase 3 studies in other indications, including non-Hodgkin’s lymphoma. We are working expeditiously to reach market approval in China for MARQIBO to treat adult Philadelphia chromosome-negative (Ph-) ALL, as well as for additional indications that may later come on board."