ODAC votes against Maxamine

An FDA advisory panel on Wednesday concluded that Maxim Pharmaceuticals (MAXM; SSE:MAXM) failed to demonstrate the efficacy or safety of Maxamine histamine hydrochloride combined with interleukin-2 for the treatment of melanoma patients with advanced disease that has metastasized to the liver. The Oncologic Drugs Advisory Committee (ODAC) voted unanimously that a single Phase III trial submitted by MAXM did not present substantial evidence of efficacy in patients with advanced melanoma or in the subgroup in which the disease has metastasized to the liver. Committee members echoed concerns articulated by FDA reviewers about the trial design, conduct and results (see BioCentury Extra, Tuesday Dec. 12). The agency reported that the apparent survival benefit in the subgroup with liver metastases, which was the indication the company had requested, could be the result of imbalances in assignment of patients to the treatment and comparator arms, and that there was no evidence that the treatment had any effect on tumor response or disease progression. ...