FDA delays Genasense trial clearance

USA-based Genta has been informed that the Food and Drug Administration is still reviewing its proposal for a confirmatory trial of Genasense (oblimersen sodium) injection in patients with chronic lymphocytic leukemia. The news of the delay to the possible approval of the fast-tracked drug, which was announced on August 18, caused shares in the cancer specialist to fall 2.7% to $1.45.

The request for a Special Protocol Assessment of the oligonucleotide drug was submitted in December 2005 and Genta believes that it has revised its proposal to fully address all the issues raised by the US regulator.

Earlier this year, Genta reported strong trial results for Genasense in CLL at the 10th annual International Congress on Hematologic Malignancies held in British Columbia, Canada (Marketletter February 27). In combination with standard chemotherapy, the drug achieved an increase in the proportion of patients reaching a complete or nodular partial remission from 7% to 17% (p=0.025). In addition, the duration of this effect was significantly longer in patients receiving the drug and chemotherapy in comparison with those subjects only treated with chemotherapy, noted Genta's president, Loretta Itri.