Deciphera Inc. submits new drug application to FDA

today, Deciphera(http:// announcedthat it has submitted its kit and PDGFR alpha kinase inhibitor ripretinib'snew drug(http://application (NDA) to the U.SFDA
(http:// for the treatment of patients with advanced gastrointestinal interstitial (GIST) who have been treated with imatinib, sunitinib and regoraibAbout Ripretinib
Ripretinib is a KIT or PDGFR alpha kinase inhibitor used to treat KIT or PDGFR alpha-driven related cancers, including GIST, systemic hyperblastoma (SM) and other cancersRipretinib is specifically designed to improve treatment in GIST patients by inhibiting broad-spectrum mutations in KIT or PDGFR alphaThe FDA has granted ripretinib fast-track eligibility and breakthrough therapy designations for the treatment of advanced GIST patients who have previously received iimatinib, sunitinib and regorafenib treatmentThe ndA submissionthe nda is based on the positive results obtained by ripretinib in phase 3test(http://INVICTUSThe trial was a randomized double-blind, placebo-controlled study in which 129 patients were treated with ripretinib or placebo on a 2:1 scale to assess the efficacy of ripretinib in patients who had previously received treatment with advanced GIST, sunitinib and reafenibThe results showed that ripretinib reached the primary endpoint of improving non-progressive survival (PFS) in patients, with PFS at 27.6 weeks in the treatment group, compared with 4.1 weeks in the placebo groupCompared to the placebo group, the risk of disease progression or death was reduced by 85 percent in the treatment groupIn addition, the objective remission rate (ORR) was 9.4% for patients in the treatment group, compared with 0% for THE PLACEbo groupThe total survival (OS) of patients in the treatment group was 15.1 months, while the total OS in the placebo group was only 6.6 months, with a significant clinical improvement