Ab Science SA: Business description, financial summary, 3yr and interim financials, key statistics/ratios and historical ratio analysis.
Provider: Reuters Investment Profile
NYSE and AMEX quotes delayed by at least 20 minutes. NASDAQ delayed by at least 15 minutes. For a complete list of exchanges and delays, please click here.
AB Science announces negative opinion from CHMP on appeal for conditional authorization of Masitinib in pancreatic cancer
AB Science SA:Says Committee for Medicinal Products for Human Use (CHMP) of European Medicine Agency (EMA) has adopted negative opinion on conditional marketing authorization for Masiviera (Masitinib mesylate) for first line treatment of non resectable locally advanced or metastatic pancreatic cancer.This decision is on appeal filed by AB Science following previous negative opinion adopted by the CHMP in January.Rapporteurs considered that evidence presented in pain and in genetic subgroups were promising, but that benefit was not sufficiently demonstrated since data were derived from subgroup analysis.Safety profile of masitinib did not raise serious issues in consideration of other more toxic alternatives used in pancreatic cancer.Majority of outstanding quality issues were resolved.However, in the absence of demonstrated benefit, CHMP considered that benefits of masitinib did not outweigh its risks at this stage of the development of masitinib.Phase 3 confirmatory study will be necessary to clearly demonstrate benefit of masitinib in target subgroups, which account for about 60 pct of pancreatic cancer patients.
Latest Developments for Ab Science SA
- AB Science announces positive preclinical results of studies on masitinib
- AB Science DSMB recommends the continuation of phase 3 study of masitinib in progressive forms of multiple sclerosis
- AB Science says DSMB recommends continuation of its phase 3 study of Masitinib in mastocytosis
- AB Science announces publication of results from randomized phase 2 study of masitinib
- Share this
- Digg this