Agency suggested that Genta needs to conduct another clinical trial.
The FDA has informed Genta that Genasense cannot be approved for chronic lymphocytic leukemia (CLL) without an additional clinical study. Unfortunately for the company, this is just the latest in a long slew of failed attempts to bring the drug to market.
Genta first filed an NDA for Genasense for the treatment of advanced melanoma in 2003. The application received a negative review and was subsequently withdrawn. Since then the company lost its partner, Aventis, could not secure an FDA go-ahead for Genasense in relapsed CLL or CLL, and obtained a negative opinion from the EMEA for advanced skin cancer.
In 2003, the firm’s stock was as high as $96. With all the bad news, the value kept sliding and dropped below $1 in November 2007. Genta was delisted from the NASDAQ in the middle of 2008.
Commenting on today’s announcement from the Office of Oncology Drug Products, Raymond P. Warrell Jr., M.D., Genta’s CEO, says, “We believe that Genasense amply demonstrated its efficacy and safety in patients with relapsed or refractory CLL in a carefully designed and well-conducted randomized clinical trial.
“While our principal focus for Genasense remains the timely completion of our randomized trial in melanoma—now more than two-thirds enrolled, CLL remains an important indication. We plan to consult with clinical and regulatory advisors in our evaluation of next steps.”
