Amgen’s Kyprolis is in the middle of a multiple myeloma battle that’s only growing more and more heated. And a roadblock from England’s cost-effectiveness gatekeepers isn’t going to help it get ahead.
Wednesday, the National Institute for Health and Care Excellence (NICE) shot down the med in combination with dexamethasone and Celgene’s Revlimid or with dexamethasone alone as a treatment for myeloma patients who have tried at least one prior therapy.
The reason? Long-term survival uncertainties that made its cost-effectiveness status hard to determine, NICE said in a draft guidance. Kyprolis didn’t meet its 24-month extension mark for end-of-life treatments, either.
The decision is just another downer for Amgen, which has been struggling with Kyprolis since it shelled out $10 billion in 2013 for maker Onyx. The drug has repeatedly failed to live up to analysts’ expectations, most recently coming up $9 million short in Q3.
And with a spate of myeloma approvals late last year, it’s under more pressure than ever to perform. Drugmakers including Johnson & Johnson, which markets Darzalex, are trying to slide their meds into earlier lines of therapy, where larger patient pools and longer treatment durations will help them pad their top lines and give Kyprolis a run for its money.
To make matters worse, it doesn’t look like Kyprolis will be enjoying the sun in the most lucrative front-line setting anytime soon. In late September, it flunked its first Phase III study in newly diagnosed patients.