Waiting for Genasense ~ a case in point

January 11, 2011

Genasense, (oblimersen sodium) (OBL) is an early Bcl-2 inhibitor that has been

stuck in the FDA approval process for a very long time.

It has been through a Phase III clinical trial for CLL and NHL. Perhaps the

endpoints were too ambitious, but what would this do in combination with other

drugs than FC??

Clinical Trials:

" Conclusion - O'Brien

In relapsed/refractory CLL, OBL combined with FC offers patients who achieve

complete or partial remission, as well as those who have fludarabine-sensitive

disease, a significant survival benefit. "

So we wait... and wait...

~chris

March 2009

Genta Incorporated announced that the Food and Drug Administration's (FDA)

Center for Drug Evaluation and Research (CDER) has decided that available data

are not adequate to support approval of Genasense® (oblimersen sodium) Injection

for treatment of patients with relapsed or refractory chronic lymphocytic

leukemia (CLL).

In a decision issued in response to an appeal filed by Genta in December 2008,

CDER concluded that new information submitted by the Company in its amended New

Drug Application (NDA) was insufficient, and the Agency has recommended

conducting a confirmatory clinical trial.

" While disappointed with this decision, we appreciate FDA's clarification of the

path to U.S. regulatory approval in this important indication, " commented Dr.

Loretta M. Itri, Genta's President, Pharmaceutical Development, and Chief

Medical Officer.

" The Company will discuss this decision with clinical and regulatory authorities

before determining our next steps. Genta greatly appreciates the professional

and collaborative communications with FDA during this process, and we look

forward to working with FDA in addressing their recommended options for securing

the confirmatory data. "

Recommended Posts