Genta Incorporated has completed the filing of a new drug application (NDA) to the US Food and Drug Administration for its lead anticancer drug, Genasense (oblimersen sodium) injection. The application proposes the use of Genasense plus fludarabine and cyclophosphamide as treatment for patients with relapsed or refractory chronic lymphocytic leukaemia (CLL).
The NDA was submitted pursuant to FDA's fast track and accelerated approval designations - programmes that are designed to expedite review of drugs that address important unmet medical needs. Assuming this application is designated for priority review, an approval action would normally occur within six months from the filing date.
The NDA contains safety and efficacy data from a disease-specific phase 1-2 trial of Genasense used alone that enrolled approximately 40 patients, as well as a randomised controlled phase 3 study of 241 patients who received fludarabine and cyclophosphamide with or without Genasense. These data are supplemented by safety data derived from approximately 1,000 additional patients who have received Genasense in other clinical trials, states a company release.
The pivotal phase 3 trial was designed to test whether the addition of Genasense to standard chemotherapy would significantly increase the proportion of patients who achieved a complete or nodular partial response.
"This submission represents a significant milestone for Genta, but it is especially noteworthy for the patients and physicians who have worked so diligently with us during the clinical development process," commented Loretta Itri, Genta's chief medical officer and president, pharmaceutical development.
Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment.
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer.