Genzyme receives "complete response" letter for Clolar
This article was originally published in Pharmaceutical Approvals Monthly
FDA has issued a "complete response" letter for Genzyme's sNDA for use of Clolar (clofarabine) in previously untreated older adult patients with acute myeloid leukemia, the firm announced Oct. 6. FDA's Oncologic Drugs Advisory Committee voted in September that data from a randomized, controlled trial was necessary to establish safety and efficacy in the proposed adult AML indication (1"The Pink Sheet," Sept. 7, 2009). FDA's letter recommends Genzyme conduct such a trial. Drug sponsors seeking approval for elderly AML have argued that randomized trials are difficult to conduct in the setting, and Genzyme sought approval based on a single-arm trial. The company is already conducting a randomized, placebo-controlled Phase III trial of clofarabine plus cytarabine in relapsed and refractory AML patients over 55, with results expected in 2011. Genzyme plans to meet with FDA to discuss whether the additional study may satisfy regulatory requirements. Clolar is already approved for pediatric ALL
You may also be interested in...
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
Senate Appropriations Committee proposes $1.185bn to CFSAN and $2.19bn to CDER, both levels short of House appropriators passed in June. FDA requested $30.36m in user fees from monograph drugs but no amount was specified in Senate draft bill.
Along with Q2 results including reported net sales up 14.3% to $1.12bn, Perrigo announces overhaul of its supply chain expected to generate $100m to $300m in net cost savings and creation of women's health, skin care business units.