FDA committee to explore Zepsyre potential development for pediatric cancers

The US Food and Drug Administration’s Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) has invited PharmaMar (MC: PHM) to participate in this ODAC, giving a presentation to provide background information on Zepsyre (lurbinectedin), positive clinical data obtained from Phases I and II, in which a good tolerance and a good safety profile were observed, and to assess the potential role of this drug in pediatric cancers and hematological disorders.

Zepsyre (PM1183), PharmaMar´s investigational drug, is one of the three products chosen by the ODAC, the Spanish drugmaker revealed.

The subcommittee will consider and discuss with PharmaMar issues concerning the diseases to be studied, patient populations to be included and possible study designs in the development of this product for pediatric use. The discussion will also provide the FDA with guidance to facilitate formulation of written requests for pediatric studies, if appropriate.