Currently, the company is carrying out a randomized, double-blind, placebo-controlled Phase III clinical trial (VALOR), in patients with first relapsed or refractory acute myeloid leukemia (AML).
A PIP is part of the EMA approval process and must be accepted prior to filing a marketing authorization application (MAA) for the drug in the European Union (EU).
The plan describes how a company intends to assess the use of a given drug in children.
The company said that completion of studies outlined in the PIP prior to EU approval is not a requirement for MAA submission if deferral for completion has been received.
Sunesis chief executive officer Daniel Swisher said the company is happy with the acceptance of its PIP by the EMA, an important step leading into a potential filing of its Marketing Authorization Application for Qinprezo in Europe.
"AML remains a significant unmet medical need, one which has seen little innovation in the last 40 years," Swisher said.
"We look forward to understanding Qinprezo’s potential within first relapsed or refractory AML with the unblinding of VALOR expected in the third or fourth quarter of 2014."
Qinprezo is a first-in-class anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer.
Preclinical data have showed that Qinprezo both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis.
Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to Qinprezo for the treatment of AML. Additionally, Qinprezo has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Qinprezo is an investigational drug that has not been approved for use in any jurisdiction.
The trademark name Qinprezo is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.