Advertisement
"We're very pleased with these results, which we believe will providesufficient clinical data to support a Section 505(b)(2) New Drug Application,"said Evan M. Levine, chief executive officer of ADVENTRX. "We have a meetingscheduled with the FDA in December to discuss our commercial manufacturingplans. After we receive the FDA's written comments, we intend to provide anupdate regarding our NDA timeline for ANX-530."
Advertisement
ANX-530 is a novel emulsion formulation of vinorelbine. Vinorelbine,marketed under the brand name Navelbine(R), also available as genericvinorelbine, is an anti-cancer agent approved to treat advanced non-small celllung cancer as a single agent or in combination with cisplatin. Worldwideannual sales of Navelbine and generic vinorelbine in 2006 were approximately$200 million.
The bioequivalence study of ANX-530 was a crossover comparison of ANX-530and Navelbine with a primary objective of demonstrating the pharmacokineticequivalence of ANX-530 and Navelbine. Determining the safety of a single doseof ANX-530 was a secondary objective. In the first week, patients were dosedwith either ANX-530 or Navelbine, and after a washout period, were dosed withthe opposite drug during the second week of treatment. The FDA has indicatedthat this single clinical study, should it demonstrate pharmacokineticequivalence between ANX-530 and Navelbine, would provide sufficient clinicaldata to support a Section 505(b)(2) NDA.
Pharmacokinetic equivalence was determined based on federal regulationsand FDA guidance regarding bioequivalence studies. If the upper and lowerbounds of the AUC ratio's and the Cmax ratio's 90% confidence interval rangedfrom 0.80 to 1.25, ANX-530 and Navelbine were considered to have equivalentpharmacokinetics. AUC is a measure of the total amount of the drugcirculating in the body over time. Cmax is the maximum concentration of thedrug measured in the blood at any given time. The results of a clinical studyare actually estimates of what might be expected if the treatment were to begiven to the entire population of interest. Confidence intervals indicate theprecision of such an estimate. Pursuant to the study's protocol andstatistical analysis plan, data from all 31 patients who received both studydrugs were included in the analysis.
About ANX-530 (vinorelbine emulsion)
ANX-530 is a novel emulsion formulation of vinorelbine tartrate, a genericchemotherapy agent. ANX-530 is designed to reduce the incidence and severityof vein irritation from intravenous-delivery of vinorelbine tartrate.Vinorelbine tartrate works by disrupting microtubule formation and is a memberof the vinca alkaloid class of antineoplastic agents. Vinorelbine is indicatedas a single agent or in combination with cisplatin for treatment of advancednon-small cell lung cancer and has also shown activity in breast, ovarian, andother cancers.
About Section 505(b)(2)
Section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act (FDCA) allows theFood and Drug Administration (FDA) to approve a follow-on drug on the basis ofdata in the scientific literature or conclusions regarding safety oreffectiveness made by the FDA in the
