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ODAC's Vote For Another Trial Could Be Death Knell For Vion's Onrigin

Executive Summary

Vion will probably have to cut its losses on the elderly acute myeloid leukemia drug Onrigin (laromustine) after an FDA panel voted unanimously Sept. 1 that another randomized trial needs to be conducted before the drug can be approved

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Cyclacel readies for sapecitabine SPA

Cyclacel will submit a Special Protocol Assessment request for its Phase III trial of sapecitabine in acute myeloid leukemia, as well as for a separate trial in myelodysplastic syndromes, during the first quarter of 2010. The company announced Dec. 15 that at a recent type A meeting with FDA, the agency confirmed that the proposed design for a randomized study would be acceptable for the SPA process - through which sponsors gain insight from FDA about clinical trial design and regulatory expectations. Consulting with FDA on the Phase III program is an even more important step in this space following an advisory committee review of two competitors; during its Sept. 1 review of applications for Genzyme's Clolar and Vion's Onrigin for the niche indications to treat elderly patients with AML, FDA's Oncologic Drugs Advisory Committee determined that randomized trials, though difficult to conduct in the space, are necessary for approval (1"The Pink Sheet," Sept. 7, 2009). Both applications have since received "complete response" letters from FDA requesting randomized, controlled trials. Genzyme has already initiated such a study (2Pharmaceutical Approvals Monthly, October 2009). Vion, however, may not be able to fulfill the request (3"The Pink Sheet" DAILY, Dec. 14, 2009)

Cyclacel readies for sapecitabine SPA

Cyclacel will submit a Special Protocol Assessment request for its Phase III trial of sapecitabine in acute myeloid leukemia, as well as for a separate trial in myelodysplastic syndromes, during the first quarter of 2010. The company announced Dec. 15 that at a recent type A meeting with FDA, the agency confirmed that the proposed design for a randomized study would be acceptable for the SPA process - through which sponsors gain insight from FDA about clinical trial design and regulatory expectations. Consulting with FDA on the Phase III program is an even more important step in this space following an advisory committee review of two competitors; during its Sept. 1 review of applications for Genzyme's Clolar and Vion's Onrigin for the niche indications to treat elderly patients with AML, FDA's Oncologic Drugs Advisory Committee determined that randomized trials, though difficult to conduct in the space, are necessary for approval (1"The Pink Sheet," Sept. 7, 2009). Both applications have since received "complete response" letters from FDA requesting randomized, controlled trials. Genzyme has already initiated such a study (2Pharmaceutical Approvals Monthly, October 2009). Vion, however, may not be able to fulfill the request (3"The Pink Sheet" DAILY, Dec. 14, 2009)

No Regulatory Slack For Tough Supplemental Indications, Pazdur Tells ODAC

FDA may hold approval of supplemental indications to a higher standard of evidence than what can feasibly be obtained since the drugs are already available to treat patients in an off-label setting, FDA Office of Drug Oncology Products Director Richard Pazdur indicated at a Sept. 1 advisory committee meeting

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