The European Medicines Agency (EMA) has validated US-based Sunesis Pharmaceuticals’ marketing authorisation application (MAA) for vosaroxin as a treatment for relapsed refractory acute myeloid leukemia (AML) in patients aged 60 years and older.
The validation confirms that the submission is complete and begins the centralised review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Under centralised review, the CHMP review period is 210 days, excluding question or opinion response periods, when the CHMP opinion will be reviewed by the European Commission (EC), which usually issues a final decision on EU approval within three months.
The MAA submission will be reviewed in the centralised procedure, which if authorised provides a marketing licence valid in all 28 EU member states.
Sunesis Regulatory Affairs and Medical Writing vice-president Deborah Thomas said: "Validation of our vosaroxin MAA begins the EMA review process and brings us another step closer to delivering a new treatment option to patients with relapsed refractory AML.
"Following encouraging interactions with the agency last summer, we look forward to progressing to the next stage of the review process, which includes the 120-day questions following the assessment report by the CHMP."
Qinprezo is the trademark name of vosaroxin conditionally accepted by both the FDA and EMA as the proprietary name for the vosaroxin drug product candidate.
It is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for treatment of the disease.
Preclinical data showed that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis.
Vosaroxin has been granted orphan drug designation by both the FDA and European Commission for the treatment of AML.
In addition, vosaroxin has been granted fast-track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine.
The company noted that vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.
