FLT3 kinase inhibitor Astellas leukemia new drug is included in the proposed priority review.

Astellas' Fumaric acid ginni tablets were added to the list of priority reviews on July 21 on the grounds that they "meet the conditions for approval," according to the latest announcement on the website of the National Drug Administration's (NMPA) Drug Review Center (CDE).
Gilitini is the next generation of FLT3 tyrosine kinase inhibitors, has been approved in the United States, Japan and Europe and other countries and regions to treat recurring or refractic FLT3 mutation acute myeloid leukemia adult patients.
it's worth noting that Gilitini has been awarded fast-track, orphan drug and priority review qualifications by the FDA.
Screenshot Source: CDE Official Website Gilteritinib is the next-generation FLT3 tyrosine kinase inhibitor (TKI) developed by Astellas in collaboration with Kotobuki Pharmaceuticals of Japan, and is a daily oral therapy that can be used to treat patients with relapsed or refractic acute myeloid leukemia (AML) with FLT3 gene mutations.
Astellas has an exclusive interest in the development, production and commercialization of the drug worldwide.
preclinical studies have shown that ginibs can inhibit two common FLT3 mutations, FLT3-ITD and FLT3-TKD, found in about one-third of patients with acute myeloid leukemia.
FLT3-ITD is a common driving mutation with high disease burden and poor prognosmation.
same time, ginib is able to maintain inhibition of FLT3 activity in the body and is less likely to produce bone marrow inhibition.
it also inhibits tyrosine kinase, a subject called Axl, blocking a potential mechanism that makes tumor cells resistant.
, Ginitinib has been approved in several countries in the United States, Japan, Canada, Brazil and Europe for the treatment of adult patients with recurring or resus treatable FLT3 mutation acute myeloid leukemia.
the United States, the FDA has granted Ginitinib fast-track eligibility, orphan drug eligibility, and priority review eligibility.
in China, Andretini's application for listing was accepted in April.
According to an earlier press release issued by Astellas, the adaptation applied for by Ginitini in China is for the treatment of adult patients with FLT3 mutation-positive (FLT3mut plus) recurrence or refragsive (therapeutic resistance) acute myeloid leukemia.
was included in the proposed priority review on the grounds that "qualified medicines were met".
means the drug is expected to accelerate approval in China.
AML is a malignant blood cancer caused by cancer of bone marrow hematopoietic stem cells and ancestral cells.
mutation that activates FLT3 tyrosine kinase is the most common genetic mutation in AML patients, with about 30 percent of AML patients affected by the FLT3 gene mutation.
acute myeloid leukemia patients who test positive for FLT3 mutation have very poor prognostication, saving less than 6 months of median survival after chemotherapy, and patients are in urgent need of new treatment options.
reference materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Retrieved Jul 21, 2020, from stelly announces that China's State Drug Administration has accepted the listing application of XOSPATA® Retrieved Aprol 10, 2020, from.