Signs that progression-free survival data would not be sufficient to support approval of Zactima (vandetanib) in advanced non-small cell lung cancer led AstraZeneca to pull the regulatory submissions for the drug, the firm announced Oct. 28. The tyrosine kinase inhibitor was filed for review with both FDA and the European Medicines Agency in June, for use in combination with chemotherapy to treat advanced NSCLC. "Preliminary feedback" from regulators indicated that PFS was not a sufficient primary endpoint for approval in this setting, AstraZeneca reported. That initial regulatory response, combined with "an updated analysis that demonstrated no overall survival advantage when vandetanib was added to chemotherapy," left the application with little support. The drug has been plagued with lackluster data throughout development. The first two of five Phase III trials were failures for vandetanib, where the drug did not meet the PFS endpoint versus pemetrexed (in ZEAL) or erlotinib (in ZEST). The third trial showed some benefit versus docetaxel in ZODIAC (1Pharmaceutical Approvals Monthly June 2009). AstraZeneca plans to complete the Phase III program; the ongoing trials are monotherapy studies, one in EGFR inhibitor-experienced advanced NSCLC (ZEPHYR) and one in advanced medullary thyroid cancer (ZETA)
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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