Sunesis Reports EMA Acceptance Of Pediatric Investigation Plan For Qinprezo

(RTTNews) - Sunesis Pharmaceuticals, Inc. (SNSS) reported that the Pediatric Committee of the European Medicines Agency or EMA has issued a positive opinion on the company's Pediatric Investigation Plan or PIP for Sunesis' lead drug candidate, Qinprezo. Currently, Sunesis is conducting the VALOR trial, a pivotal Phase 3, randomized, double-blind, placebo-controlled study in patients with first relapsed or refractory acute myeloid leukemia or AML.

A PIP is part of the EMA approval process and must be accepted earlier to the submission of a Marketing Authorization Application or MAA for the drug in the European Union. A PIP describes how a firm plans to assess the use of a given drug in children. Completion of studies outlined in the PIP prior to European Union approval is not a requirement for MAA submission if deferral for completion has been received.

Qinprezo is a first-in-class anti-cancer quinolone derivative, a class of compounds that has not been used previously for cancer.