IDM's mifamurtide gets non-approvable letter from FDA

California, USA-based biopharmaceutical firm IDM Pharma has received a "non-approvable" letter from the Food and Drug Administration for its developmental anticancer agent mifamurtide (L-MTP-PE; formerly known as Junovan). The drug, which had been intended as a treatment for non-metastatic osteosarcoma, failed to convince the FDA of its therapeutic benefits.

In May this year, the FDA's Oncologic Drugs Advisory Committee concluded, 12 votes to two, that data included in the New Drug Application, originally filed late last year (Marketletter November 6, 2006), did not support mifamurtide's efficacy as a treatment for osteosarcoma. In its subsequent letter, the FDA reiterated this conclusion and requested that additional trials be conducted to demonstrate the drug's therapeutic benefits. The agency also asked for clarification on certain other sections of the NDA.

Irvine, California-headquartered IDM said that it continues to "strongly believe in the overall survival benefit and safety profile of L-MTP-PE for the treatment of osteosarcoma," adding that it remains committed to gaining approval for the drug. The firm said that it would work to collect survival data from patients who participated in the original Phase III trial but were not available at the time the NDA was filed.