EMEA accepts Genta's MA for Genasense
New Jersey, USA-based biotechnology company Genta says that it has received notice from the European Medicines Agency (EMEA) that its Marketing Authorization Application for Genasense (oblimersen) has been validated for review by the Agency, which signals the start of the scientific assessment procedure.
The application proposes the use of Genasense plus dacarbazine for the treatment of patients with advanced metastatic melanoma, particularly for those with normal baseline levels of serum lactate dehydrogenase. Summary data that support this application can be viewed at: www.genta.com.
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