PharmaMar to present findings to FDA's Pediatric Oncology Subcommittee

PharmaMar will present clinical data from Phase I and II studies examining Zepsyre’s effect on pediatric cancers and hematological disorders to the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration.

Zepsyre is among three investigational drugs that will go before ODAC. The committee will look at tolerance and safety information for Zepsyre.

“We are pleased to have been chosen to participate in the pediatric subcommittee meeting,” Luis Mora, managing director of the Oncology Unit, said in a statement. “Given the mechanism of action of Zepsyre as well as the available clinical data from phases I and II, in which we observed a good tolerance and a good safety profile, we believe that there may be potential relevance for PM1183 to be developed in one or more pediatric cancers.”