T

he FDA has weighed in on Novartis’ pioneering personalized cancer therapy, which looks almost certain to win approval. But the agency is wading into uncharted territory, bringing along a bevy a questions on manufacturing and long-term safety to a hotly anticipated public forum.

In briefing documents released before a Wednesday hearing on Novartis’ treatment, FDA staff made clear that it has little doubt the therapy is effective in treating advanced cases of leukemia in children and young adults. Of greater concern is whether Novartis can reliably produce and deliver the treatment, and whether the children and young adults who receive it stay healthy years after dosing.

This is a STAT Plus article and is only available to STAT Plus subscribers.
To read the full story, subscribe to STAT Plus or log in to your account.
Good news: your first 30 days are on us.

Leave a Comment

Please enter your name.
Please enter a comment.

Recommended Stories

Sign up for our biotech newsletter, The Readout

A guide to what’s new in biotech — delivered straight to your inbox every weekday morning.