Clinical setbacks in Clinical Development

Big Pharma like Pfizer is facing rising pressure from the easing generic competition, patent cliffs and investor pressures has made them conduct clinical studies for more than one indication. However clinical setbacks are increasingly becoming part of various company programs despite efforts to ensure that the relevant and suitable clinical endpoints are achieved.

One of the major concerns for various drug majors today is safety. A recent example of this is as follows: -Pfizer has suffered a clinical setback with the news that a late-stage trial of its oncology blockbuster Sutent as a potential treatment for liver cancer has been halted over safety concerns. The New York-based giant has discontinued the SUN 1170 Phase III study of Sutent (sunitinib) in advanced hepatocellular carcinoma following a review by an independent data monitoring committee. It has been halted because of a higher incidence of serious adverse events in the sunitinib arm of the trial compared to Bayer/Onyx' Nexavar (sorafenib).

This blog is co-posted with the Veeda Clinical Research Blog.