FDA's Drugs@FDA database lists a supplement to NDA 208716, Eli Lilly's abemaciclib marketed as Verzenio, dated 18 September. The record does not say what the supplement covers.
Supplements include labelling updates, manufacturing changes and new indications, and are frequent. Until the revised label is published, this changes nothing about prescribing. Any Indian label change would come through CDSCO separately.
- No change to abemaciclib prescribing follows from this listing.
- Check the FDA label when the revised version is posted.
- Continue monitoring for diarrhoea, neutropenia and liver enzymes.
Why it matters
Abemaciclib is widely used in hormone receptor-positive breast cancer, so label changes are worth tracking.
Don't overread it
A licence supplement is not a new indication or a safety finding.
Read the rest in the app
You have read your two free briefings this month. The app carries all 27 specialties, every morning, free — and this finding is waiting in it.
Scan to keep reading on your phone. No account needed to start.
Tomorrow morning, before your first patient
One edition a day for oncology, written by the desk, every claim tied to its paper. Six minutes.
Get the app — free