Genta and Aventis terminate EAP for Genasense

Published: 1-Jun-2004

Genta and Aventis have terminated the Expanded Access Program (EAP) for Genasense (oblimersen sodium) Injection in combination with dacarbazine (DTIC).


Genta and Aventis have terminated the Expanded Access Program (EAP) for Genasense (oblimersen sodium) Injection in combination with dacarbazine (DTIC).

The decision to close the program was made subsequent to the May 3, 2004, meeting of the Oncologic Drug Advisory Committee (ODAC), at which the results of the Genasense Phase III metastatic melanoma trial were discussed. At that meeting, the committee voted that there was insufficient evidence to recommend approval at this time.

The companies are working with the FDA to review key issues and to identify next steps related to further development of Genasense in advanced malignant melanoma. As previously announced on May 13, Genta withdrew its New Drug Application for Genasense in advanced malignant melanoma.

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