Back to the drawing board for Ceplene

The US Food and Drug Administration has issued a non-approvable letterto Maxim Pharmaceuticals relating to its New Drug Application for Ceplene (histamine dihydrochloride, which was formerly called Maxamine) as an adjuvant to interleukin-2 for the treatment of patients with advanced metastatic melanoma with liver metastases.

According to the FDA, the US Phase III clinical trial forming the basis of the NDA would not be adequate as a single study to support approval. The news came as little surprise, given that an FDA Oncology Drug Advisory Committee had declined to recommend the product late last year (Marketletter December 18, 2000), and this now means that the company has to pretty much go back to square one.

Maxim's chief executive, Larry Stambaugh, acknowledged that the decision was expected but added that, "despite this regulatory action, the trial did show a significant survival benefit in a patient population with a fatal disease that has a critical need for more effective therapies." As a result, he said, "we will meet with the FDA to develop a clinical strategy to support the approvability of this drug in this patient population."