Pfizer Sutent Potential Adrenal Toxicity Concern Surfaced Early In FDA Review
This article was originally published in Pharmaceutical Approvals Monthly
Review documents for Pfizer's Sutent show early, pre-NDA concern within FDA's oncology division relating to the multi-targeted tyrosine kinase inhibitor's potential to cause adrenal toxicity
You may also be interested in...
FDA’s decision to grant Pfizer’s Sutent a broad renal cell carcinoma claim suggests a consensus among reviewers that partial responses may be predictive of clinical benefit in RCC.
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011