Camizestrant nears India approval after panel backs ESR1 mutation patients
Camizestrant, a promising new breast cancer drug, is close to approval in India after already making its way into the US the E.U. the U.A.E. and Saudi Arabia.
An expert panel here has recommended it for patients whose cancers are becoming resistant to hormone treatments because of the ESR1 mutation.
Camizestrant trial shows 16 months progression-free
In a trial involving 315 patients, Camizestrant helped patients go about 16 months without their cancer getting worse, much better than the 9.2 months seen with older treatments.
Camizestrant helped patients go about 16 months without their cancer getting worse.
Given how urgently this is needed, Indian authorities may skip local phase 3 trials and require only a prescription from a medical oncologist if it's approved.
Just a heads-up: the FDA approval carries warnings about irregular heart rhythm, slow heart rate and potential harm to an unborn baby, so doctors will keep a close watch if it rolls out here.