No New Patients For Lartruvo In EU After Trial Failure
The EMA says that in light of the disappointing results of the ANNOUNCE trial, no new treatments should be initiated with Lilly’s Lartruvo in patients with soft tissue sarcoma. This is the first time the agency has taken action such as this on a product that has received a conditional marketing authorization.
You may also be interested in...
News that the soft tissue sarcoma drug will come off the market after its confirmatory trial failed to verify clinical benefit spurs Memorial Sloan-Kettering’s Peter Bach to ask whether Lilly will refund money to payers.
Lilly withdraws soft tissue sarcoma drug for failure to confirm clinical benefit two and a half years after US FDA awarded accelerated approval, becoming the fastest withdrawal yet under the regulatory pathway.
The European Medicines Agency is conducting safety reviews of Eliquis, Pradaxa and Xarelto, and is looking at whether the marketing authorization for the anticancer medicine Lartruvo should be maintained. It has also asked manufacturers of angiotensin II receptor blockers to review their manufacturing processes to ensure they do not produce nitrosamine impurities. Meanwhile, manufacturers of omega 3 fatty acid medicines have requested a re-examination of a CHMP recommendation on their products.