Date: 2016-01-04
Type of information: Submission of a Market Application in the EU
Product name: Qinprezo™
Compound: vosaroxin
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism: antibiotic/quinolone. Qinprezo™ (vosaroxin) is an anti-cancer quinolone derivative, a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the FDA and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine.
Company: Sunesis Europe Ltd (UK)
Disease: acute myeloid leukaemia
Latest news: * On January 4, 2016, Sunesis Pharmaceuticals announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for vosaroxin as a treatment for relapsed refractory acute myeloid leukemia in patients aged 60 years and older. Validation confirms that the submission is complete and initiates the Centralized Review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Under Centralized Review, the CHMP review period is 210 days, excluding question or opinion response periods, after which the CHMP opinion is reviewed by the European Commission, which usually issues a final decision on EU approval within three months. The MAA submission will be reviewed in the Centralized Procedure, which if authorized, provides a marketing license valid in all 28 EU member states. ,* On December 8, 2015, Sunesis Pharmaceuticals announced that the company has submitted a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for Vosaroxin for the treatment of acute myeloid leukemia in patients aged 60 years and older. The application is subject to validation by the EMA, a process which typically takes one month, before the formal regulatory review of the application begins. * On October 7, 2015, Sunesis Pharmaceuticals announced that the company intends to submit a Marketing Authorization Application (MAA) for vosaroxin as a treatment for acute myeloid leukemia (AML) with the European Medicines Agency (EMA) by the end of 2015. The company recently announced that it met separately with the Rapporteur ( United Kingdom ) and Co-Rapporteur ( Netherlands ) assigned to provide advice and guidance to the company through the MAA process. Based on these discussions, the company is proceeding with an MAA filing for the indication of relapsed/refractory acute myeloid leukemia in patients age 60 years and older, a population with the greatest medical need and for whom the greatest benefit was observed in the vosaroxin/cytarabine treatment arm of VALOR, the company's pivotal Phase 3 study of vosaroxin and cytarabine in adult patients with relapsed or refractory acute myeloid leukemia. * On March 8, 2012, the COMP adopted positive opinion recommending vosaroxin for treatment of acute myeloid leukaemia for designation as orphan medicinal products to the European Commission.
Patents: * On November 30, 2015, Sunesis Pharmaceuticals announced that the European Patent Office (EPO) has granted European Patent No. 2 049 109 B1, claiming certain combined uses of vosaroxin and cytarabine, at doses of 10-120 mg/m2 and 5-1500 mg/m2, respectively, for the treatment of acute myelogenous leukemia and acute myeloblastic leukemia. The patent further provides for combinations of vosaroxin and cytarabine with other therapies, such as radiation, or other chemotherapeutics, including anti-cancer agents, in hematologic disorders, whether administered simultaneously or sequentially. Sunesis is proceeding to validate this patent in multiple EPO member states. The resulting national patents would expire in the third quarter of 2027, but could be eligible for supplementary patent term in EPO member states beyond this date. Related patent applications are pending in several countries, including the United States and Japan.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE: 2015-12-08
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA: 2009-10-28
Orphan status UE: 2012-04-26
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
