Enrolment halted in key Avastin Phase III adjuvant breast cancer trial
This article was originally published in Scrip
Executive Summary
Enrolment in a key pivotal Phase III trial testing Roche (Genentech)'s Avastin (bevacizumab) in adjuvant breast cancer has been suspended because the threshold of numbers of cases of congestive heart failure (CHF) had been met, highlighting the higher safety hurdle that needs to be demonstrated in the adjuvant disease setting. The trial's Data Safety Monitoring Board (DSMB) will decide if and when to resume enrolment, which will be a major decision for Avastin’s future in adjuvant breast cancer.
You may also be interested in...
2011 Scrip 100: A new look at cancer chemoprevention
The development of drugs to prevent cancer has lagged far behind the development of drugs, such as the statins, to prevent cardiovascular disease. But consideration of new, "personalised" clinical trial designs and an improved understanding of the biology of precancers, as well as new agents which target their molecular abnormalities, may make the field a more promising investment, says Malini Guha.
Janssen-Cilag's Xeplion recommended for EU approval for schizophrenia
Janssen-Cilag's (Johnson & Johnson) injectable drug Xeplion (paliperidone palmitate) has been recommended for European approval by the CHMP for the treatment of schizophrenia.
Pfizer's Xiapex recommended for EU approval for Dupuytren's contracture
The CHMP has recommended for European approval Pfizer's Xiapex (collagenase clostridium histolyticum) for the treatment of Dupuytren’s contracture, a potentially debilitating hand condition.