The Oncologic Drugs Advisory Committee (ODAC) recommended yesterday against approval of pixantrone for the treatment of recurrent or refractory aggressive non-Hodgkin’s lymphoma (NHL).
ODAC voted unanimously against the approval of pixantrone, saying that the drug did not demonstrate a statistically significant improvement over the control arm. The complete response rate was 20.0% with pixantrone and 5.7% with the comparator therapies.
ODAC also expressed concern that the phase 3 trial was stopped early at 44% of planned enrollment due to poor accrual. And only 8 of the 70 patients enrolled were US patients, raising concern about whether the results held true for the US population.
Pixantrone dimaleate, an aza-anthracenedione, is developed by the Seattle-based Cell Therapeutics, Inc.
ODAC also considered the application of Australian drug maker ChemGenex Pharmaceuticals for omacetaxine mepesuccinate. In a 7-1 decision, ODAC recommended a single genetic test be developed and approved prior to consideration of omacetaxine for the treatment of adults with chronic myeloid leukemia with the Bcr-Abl T3151 mutation.
The drug maker used 2 different tests to identify patients with the mutation. In addition, 23 of 66 patients did not have central laboratory confirmation of the mutation. ODAC was concerned that the comparability of the tests was unknown.
The applicant had submitted data on efficacy and safety prior to completing the planned enrollment of 100 patients, which meant that data from approximately a third of the planned population were missing at the time of consideration.
The US Food and Drug Administration usually follows the recommendations of ODAC.
