FDA accepts additional listing application from Boxei Spree (dasatinib)

Ph-ALL is a rare subtype of ALL, a common childhood cancer, accounting for about 3-4% of all children with ALLThe difference between Ph-ALL and standard ALL is that a mutation carried by a patient with Ph-ALL combines two typically absent BCR and ABL genesrecently, BMS announced that itthe FDA's, which accepted a supplementary listing application from thecompany's, for ScelatinibSprycel will be used in conjunction with chemotherapy to treat newly diagnosed patients with philadelphia chromosomal-positive (Ph-plus) acute lymphatic leukemia (ALL) childrenThe FDA is expected to respond by December 29, 2018understanding of imatatinib's drug resistance mechanism led to the development of a new BCR-ABL tyrosine kinase inhibitor, a promising new generation inhibitorIt is about 300 times stronger than Imatinib and inhibits SRC family kinasesDasatinib was first approved by the FDA in 2006 to treat adult patients in chronic conditions who are resistant to or intolerant of pre-treatments, including imartinSince then, Dashatinib has received FDA approval for the treatment of Ph-ALL, as well as newly diagnosed Ph-CML-CP adult patientsDasatinib has been approved for these indications in more than 50 countriesIn November 2017 and July 2018, the FDA and the European Commission approved the expansion of Dasatinib's indications to Ph-CML-CP in childrenthe application submitted by the BMS is based on the ongoing CA180-372 (NCT01460160) Clinical Phase 2Trial (data) the trial was designed to assess the effectiveness of the introduction of dasatinib treatment in the berlin-frankfurt-m?nster basic chemotherapy course for newly diagnosed children with Ph-ALL Seventy-five patients received up to two years of standard chemotherapy, gatasatinib Since then, patients have been followed for up to 5 years to understand their performance after treatment