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Blog & Resources Camargo Blog February 7th, 2008

A Single Phase 3 Trial Needed for 505(b)(2) Approval of a Combination Drug

Alchemia Ltd., an Australian pharmaceutical company, announced that it had gained agreement with FDA that a single Phase 3 trial would suffice for approval of its chemotherapeutic drug HA-irinotecan (a new drug containing irinotecan (Pfizer’s Camptosar®) formulated with hyaluronic acid (HA). Alchemia has conducted phase 1 and 2 studies outside the U.S. It presented the results of these trials to FDA in a pre-IND meeting.

Currently Camptosar is combined with Erbitux®(cetuximab) to treat colorectal cancer. According to the press release, the single phase 3 study “will enroll around 400 patients with metastatic colorectal cancer who have failed previous treatments. Half of the patients will receive Alchemias HA-irinotecan in combination with Erbitux®whilst the control arm will receive unmodified irinotecan plus Erbitux®. The primary endpoint will be progression-free survival (PFS). The study will be double-blinded such that the patient and the clinician will not know which treatment is being administered.”

A learning from this news is that a Sponsor does not need to conduct all studies in the U.S. However, the foreign-based studies must meet U.S. regulatory needs. We are a bit surprised that Alchemia advanced to Phase 2 without the pre-IND meeting. Some sponsors may feel this is an unneeded risk. Camargo has seen numerous cases where the foreign-based trials do not meet FDA requirements – the sponsor has to do the trials over.



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