Zactima’s FDA Application withdrawn (NASDAQ:AZN)
In June 2009, AstraZeneca (NASDAQ:AZN) submitted applications to both the United States of America’s regulator the Food & Drug Administration (FDA) and the European Medicines Agency (EMEA), which is the European equivalent of the FDA. The applications were submitted for the drug that the company has recently discovered and developed – called ZACTIMA (the proposed brand name for the generic drug vandetanib). The company proposed to use Zactima together with chemotherapy for treating patients who have been diagnosed with advanced non-small cell lung cancer (NSCLC). Each tablet of Zactima was of 100 mg. The pharmaceutical company was expecting to receive the FDA’s decision on January 30, 2010, after the former submitted results from the Phase 3 trial. However, the data from the Phase 3 trial turned out to be very unfavorable. As a result, AstraZeneca withdrew its regulatory submissions from both the Food & Drug Administration and the European Medicines Agency. The announcement of the withdrawal was made by the company itself on October 28, 2009.
So, what unfavorable results did the Phase 3 trial show? According to the company, the Phase 3 trial showed that a patient with NSCLC did not survive for a longer period if he or she was treated with vandetanib in combination with chemotherapy. This was the main reason why AstraZeneca decided to withdraw its submissions. In addition, the regulatory agencies the FDA and the EMEA that the information included in the submission – that included “progression-free survival (PFS) as the primary endpoint” – was not enough to get their’ approval for marketing Zactima.
However, some aspects of the Phase 3 trial results were favorable. For instance, the trial showed that vandetanib is “clinically active” if used together with chemotherapy. The results show that there is still hope of getting the approval to market Zactima. As a result, AstraZeneca has been conducting various Phase 3 trials in different clinical settings. It hopes to complete all the trials by Janaury 2010, after which it will again submit its applications to the FDA and the EMEA.
Related Articles:
