AstraZeneca (AZ) just issued a press release noting that they are withdrawing their application for the “multi-kinase inhibitor” Zactima (vandetanib) to receive FDA approval to be given along with chemo in advanced NSCLC right now.  Zactima is a pill that has the potential to block both the EGFR and VEGF (angiogenic) pathway, and I’ve described some of the larger clinical trials being pursued by AstraZeneca with Zactima in a prior post.   I also covered the more complete presentations of the data earlier this year and why I felt that the benefits of Zactima appeared quite underwhelming, while member and GRACE board member Neil Berch made an argument favoring a meaningful benefit with Zactima.  

     Several months ago, AZ had filed an application with the FDA for approval of Zactima along with chemo, based on the modestly positive results of the ZODIAC and ZEAL trials.  Though I don’t know any back story, I presume the signals that they were getting were primarily that there were more people underwhelmed than impressed by these results, because they’ve withdrawn that application now.

   One of the conlcusions that Neil and I agreed on was that it would be important and helpful to see a survival benefit in the ZEPHYR trial, which compares Zactima to placebo in patients with advanced NSCLC who have previously received an oral EGFR inhibitor.  The results of that trial are anticipated to be released in the next several months, so AZ may be prioritizing its efforts and resources for Zactima by channeling them toward a campaign as a single agent therapy rather than combined with chemo. 

   I look forward to learning the results of the ZEPHYR trial, and we’ll definitely discuss them when they become available.

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