ODAC Votes No on Genasense Accelerated Approval for CLL

Publication
Article
Oncology NEWS InternationalOncology NEWS International Vol 15 No 10
Volume 15
Issue 10

The Oncologic Drugs Advisory Committee voted 7-to-3 against recommending accelerated approval for Genasense (oblimersen sodium, Genta) to treat relapsed/refractory chronic lymphocytic leukemia (CLL) in combination with fludarabine (Fludara) and cyclophosphamide.

SILVER SPRING, Maryland—The Oncologic Drugs Advisory Committee voted 7-to-3 against recommending accelerated approval for Genasense (oblimersen sodium, Genta) to treat relapsed/refractory chronic lymphocytic leukemia (CLL) in combination with fludarabine (Fludara) and cyclophosphamide.

Genasense increases the activity of chemotherapy drugs by stimulating apoptosis through downregulation of Bcl-2. Genta presented data from a pivotal, randomized phase III trial in 241 relapsed/refractory CLL patients, with response rate as its primary endpoint. Patients received fludarabine/cyclophosphamide with or without Genasense.

The study showed a significant difference in major response rates (complete response plus nodular partial response) between the Genasense arm and the control group (17% vs 7%), and a significantly more durable response (median 22 months for controls vs not reached at an estimated 3 years for Genasense). The company argued that response rate could serve as a surrogate for clinical benefit.

FDA's medical review team, however, argued that the trial did not meet the standard for accelerated approval, which requires "substantial evidence of safety and efficacy demonstrated in adequate and well-controlled trials (plurality indicating multiple trials)." Nor did it find that the results indicated that Genasense was "reasonably likely" to predict a clinical benefit in CLL patients. The drug did not improve overall response rate (CR/nPR/PR), time to progression, overall survival, or symptoms, compared with controls, and had added toxicity.

Related Videos
Investigators must continue to explore the space for lisocabtagene maraleucel in mantle cell lymphoma, according to Manali Kamdar, MD.
Those with CML should discuss adverse effects such as nausea or fatigue with their providers to help optimize their quality of life during treatment.
A panel of 4 experts on multiple myeloma
A panel of 4 experts on multiple myeloma
Patients with CML can become an active part of their treatment plan by discussing any questions that come to mind with their providers.
A panel of 4 experts on multiple myeloma
Video 1 - 4 KOLs are featured in "Treating Patients Referred to Academic Centers for CAR T"
Video 1 - 4 KOLs are featured in "Identifying Potential Candidates for CAR T-Cell Therapy"
Beth Faiman, CNP, PhD, an expert on multiple myeloma