Novartis pauses some trials of cancer drug Kisqali to fix manufacturing

Hi Christos,

I don’t think that this is an error or a joke. Ribociclib is currently authorized as anti-cancer drug, but a new study suggest the efficacy of Ribiciclib to prevent the risk of recurrence AFTER surgical removal:
Adding Ribociclib to Hormonal Therapy Reduces Risk of Recurrence for People With Most Common Subtype of Breast Cancer
In this case, because the cancer has been removed, such terapy cannot be strictly considered “for advanced cancer indications as defined in the scope of ICH S9”. I suppose that Novartis is doing a similar clinical trial.
In fact Novartis suspended the clinical trial only, not the marketed drug product.
Of course this is only a supposition, but I think that it is reasonable.

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