Genta Incorporated has received notice that its New Drug Application (NDA) for the use of Genasense plus chemotherapy in patients with chronic lymphocytic leukaemia (CLL) has been deemed non-approvable by the Food and Drug Administration.
"We are keenly disappointed by this decision", said Dr Raymond P Warrell, Jr, Genta's chief executive officer. "We believe that Genasense has amply demonstrated its efficacy and safety in patients with relapsed and refractory CLL in a carefully designed and executed randomised clinical trial. As we decide on next steps with this application, we will continue working to seek worldwide approval of Genasense for patients who have advanced cancer."
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 is pursuing a broad clinical development programme with Genasense evaluating its potential to treat various forms of cancer.
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. The company's research platform is anchored by two major programs that centre on oligonucleotides (RNA- and DNA- based medicines) and small molecules. Genasense (oblimersen sodium) Injection is the company's lead compound from its oligonucleotide program.
Genta has completed a pending Marketing Authorization Application to the European Medicines Agency (EMEA) for use of Genasense plus dacarbazine for treatment of patients with advanced melanoma. The leading drug in Genta's small molecule program is Ganite (gallium nitrate injection), which the company is exclusively marketing in the US for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration.