The PDUFA Date for Astra Zeneca‘s Brilanta is still a ways off, not until July 20, 2011 but we think it’s safe to call this one an approval. AZN has had it’s problems with this application since the original submission in 2009. Initially rejected by the FDA for a variety of problems including manufacturing issues, their latest CRL only cited a reanalysis of some of the clinical data and required a post marketing safety plan, REMS. We think that AZN has probably solved both issues with the FDA. The earlier approval this year by the European Authorities and the approval earlier this month by the Canadians probably reflects the reanalyzed data. We wouldn’t be surprised if the approval came before the PDUFA Date.
Posts tagged ‘AZ’
On December 2, 2010, Astra Zeneca will present data to the FDA Oncology Advisory Committee for ZICTIFA (vandetanib) hoping to get their recommendation for the treatment of unrestable (non-operable) locally advanced or metastatic medullary thyroid cancer.
This should be an interesting discussion to watch – a study of contrasts. While the disease is not one of the most serious cancers, the clinical trial data show a more than 50% increase in survival time BUT with a 31% incidence of serious adverse experiences compared to only 13% for placebo. So, the balance of a significant improvement in survival will be compared with a significant incidence of serious adverse experiences will be discussed. How does FDA feel about this? They appear to be leaning towards approval of this drug but with some caveats. They are asking the Committee to discuss 2 options that will help improve the benefit risk ratio. The first is restricting the labeling to a more serious patient population than AZ is seeking. The FDA is asking the Committee to limit use to patients with progressive, symptomatic medullary thyroid cancer. The second option is for the Committee to discuss the evaluation of lower doses in a post-marketing study.
If AZN can provide the sub group analyses that show similar improvement in these more serious patients and also provide data showing a reduction in the incidence of the serious adverse events in patients who had their dose adjusted downward, the Committee might be just inclined to give their recommendation for approval in this limited population with more specific instructions on dosing.