"Ribolaris" clinical trial has been partially suspended due to nitrosamine impurities in ribociclib batches

[chrischar]

thanks Naiffer for the information,
most probably this is related to the below discussion

Novartis pauses some trials of cancer drug Kisqali to fix manufacturing

Hi Yosuke, is getting more and more weird…as far as i know this drug is for patients for advanced cancer, so the corresponding nitrosamine should be controlled under the limits of ICHQ3, according to the ICHS9. ‘‘The FDA has sought to reduce patient exposure to nitrosamine impurities over worries they might cause cancer in Ph-3 trials of breast cancer drug Kisqali.’’ !!! is this a joke? It is not reasonable to me to set limits to address any cancer risk <1/100000 to patients who are suffering …

Giovanni has given a fine supposition on this
‘’ 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”.
thanks
Christos