L’Agence nationale de sécurité du médicament et des produits de santé (ANSM) - Published 07July24
ANSM taking a health policy decision to partially suspend the Ribolaris clinical trial and modify its implementation procedures following the discovery of nitrosamine-type impurities at levels exceeding international standards in certain batches of ribociclib. In France, 230 patients are included in the Ribolaris clinical trial, which aims to evaluate the safety and efficacy of ribociclib as an adjunct to primary treatment in certain early breast cancers.
Nitrosamines are potentially carcinogenic impurities whose mutagenic effect has been confirmed in animals. Their presence is strictly controlled and must meet international standards. However, some batches of ribociclib used in the Ribolaris clinical trial promoted by SOLTI Start-Up Group (ClinicalTrials.gov), have a nitrosamine level exceeding the authorized thresholds for early-stage breast cancers
thanks Naiffer for the information,
most probably this is related to the below discussion
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