High Death Risk Tied to mTOR Drugs in Cancer

cp418

http://www.medpagetoday.com/MeetingCoverage/MGUCS/37404?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&xid=NL_DHE_2013-02-18&eun=g376694d0r&userid=376694&email=jlong@i-review.com&mu_id=5369993

High Death Risk Tied to mTOR Drugs in Cancer

gpawelski

As the two meta-analyses found excess fatal adverse events in drugs that target VEGF (JAMA 2001 and J Clin Oncol 2012;30), both Afinitor and Torisel are just different classes of drugs that target VEGF. There are Avastin and Zaltrap at the protein level, and Iressa, Tarceva, Nexavar and Sutent at the tyrosine kinase level. Unlike a drug like Tarceva, that targets a specific tyrosine kinase, mTOR is a complex and multifaceted target.

The USFDA issued a final rule a couple of years ago that clarified what safety information must be reported during clinical trials of investigational drugs and biologics. This includes findings from clinical or epidemiological studies that suggest a significant risk to study participants, and serious suspected adverse reactions that occur at a rate higher than expected.

The rule also provided examples of evidence that would suggest that an investigational product may be the cause of a safety problem. Under previous regulations, drug sponsors often reported all serious adverse events, even if there is little reason to believe the product caused the event. Such reporting complicated and delayed the FDA’s ability to detect a safety signal. The examples addresses when a single event should be reported or when there is need to wait for more than one occurrence.

In addition, the rule revised definitions and reporting standards so that they are more consistent with two international organizations, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and the World Health Organization’s Council for International Organizations of Medical Sciences. The changes were designed to help ensure harmonized reporting of globally conducted clinical trials.