The FDA's Oncologic Drugs Advisory Committee (ODAC) voted unanimously Wednesday that two trials of Spectrum Pharmaceuticals Inc.'s Qapzola (apaziquone) didn't demonstrate significant evidence of a treatment effect in patients following resection of nonmuscle invasive bladder cancer. In addition to the failed endpoints and the pooling of data from the two trials, the committee was concerned about missing data, which accounted for about one-fifth of the patients in the two-year follow-up for each trial, according to a Cortellis Regulatory Intelligence report. Since the endpoints were reduction in disease recurrence at two years, the missing data were important in determining efficacy. The 0-14 vote wasn't so much a no as a "not yet." ODAC attributed much of the problem to trial design errors, with some of the members saying it appeared that the trials failed – not the drug. The panel encouraged future development of the alkylating agent, given the unmet need in invasive bladder cancer. Spectrum, of Henderson, Nev., is currently evaluating the drug in a large, randomized trial, conducted under a special protocol assessment. The trial is testing a hypothesis, based on a post hoc analysis of the previous trial data, suggesting that the timing of the intravesical therapy following resection could enhance the drug's treatment effect. The ODAC vote spurred heavy trading Wednesday, with Spectrum (NASDAQ:SPPI) down 8.2 percent. It closed at $5.04, down 45 cents. (See BioWorld Today, April 6, 2012.)

The U.S. Drug Enforcement Administration (DEA) is proposing updates to its regulations covering domestic transactions and the import/export of controlled substances, listed chemicals, and tableting and encapsulating machines. The revisions, slated for publication in Thursday's Federal Register, clarify existing DEA policies, reflect current procedures and technological advancements, and implement Executive Order 13659, which requires government-wide use of the International Trade Data System. The proposed amendments also would implement recent changes to the Controlled Substances Import and Export Act involving the re-exportation of controlled substances among members of the European Economic Area. Comments on the DEA amendments are due by Oct. 15.