Kalydeco Expands Indication Without Clinical Data; Keytruda Is Latest Bladder Cancer Approval
Keeping track of US FDA approvals last week included watching the creative and the familiar.
You may also be interested in...
Fresenius Kabi’s Omegaven is most recent of 13 approvals, including three with breakthrough therapy designations, where FDA has relied on real world evidence to make a regulatory decision about efficacy.
In patients with previously untreated metastatic bladder cancer with low PD-L1 expression, PD-1 drugs alone don't work as well as chemo.
But reminds sponsors that more trials could be ordered post-approval, which may be important in face of evidence that tissue-agnostic cancer therapies are not always equally effective.