FDA accepts NDA for Genasense in advanced melanoma
The FDA has accepted the New Drug Applications for Genasense (oblimersen sodium), the first systemic antisense therapy for cancer, submitted by French pharma company Aventis and biopharmaceutical company Genta, of the US.
The FDA has accepted the New Drug Applications for Genasense (oblimersen sodium), the first systemic antisense therapy for cancer, submitted by French pharma company Aventis and biopharmaceutical company Genta, of the US.
The NDA proposes the use of Genasense in combination with dacarbazine for the treatment of patients with advanced melanoma who have not previously received chemotherapy. In addition, the FDA granted Priority Review status to the application, which targets an agency action on or before 8 June, 2004.
Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis. By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current treatments for advanced melanoma.
'This New Drug Application represents the first clinical indication for a drug that promotes chemotherapy-induced apoptosis, the first systemic use of an antisense therapy, as well as the first new drug for patients with advanced melanoma in almost 30 years,' said Dr Loretta M. Itri, Genta's president, pharmaceutical development and chief medical officer. 'During the review period, we will work closely with the FDA as we seek regulatory approval for this potential new treatment option for patients with advanced melanoma.'