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news.Genta Incorporated has filed a formal appeal against the recent non-approvable decision by the FDA over its Genasense injection for patients with chronic lymphocytic leukemia.
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The application proposed the use of Genasense in combination with chemotherapy for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL).
In a phase III trial of Genasense the primary endpoint was seen as a complete response. Complete responses were more than doubled if the chemotherapy regimen included Genasense compared to chemotherapy used alone – an increase that was statistically significant.
The median duration of complete response exceeded three years, at least 50% longer, if the chemotherapy regimen included Genasense – a significant increase in a prospectively specified secondary endpoint.
“It is puzzling that the office would deny approval to a drug that met both its primary as well as a key secondary endpoint, especially since these findings were observed in the only randomized controlled trial that has ever been conducted in patients with relapsed CLL,” said Dr Alexandra Levine, chief medical officer at the City of Hope National Medical Center.