Approach for N-Nitroso Imatinib Limits: Database vs ICH S9

[chrischar]

I would agree with Naiffer.

To be honest, reading the therapeutic indications of Imatinib i cannot see where it is written clearly that it should be used for advanced cancer.

Neverthelss, as in its indications there are quite many which are not relative with advanced cancer, i would propose to follow the ‘‘worst case’’ scenario and proceed with the acceptance intake of 1500ng/day.

This case reminds me the case of Ribociclib, where as long as it has only one indication for advanced breast cancer there were no relative AI in the nitrosamines guideline but from the moment a second indication added for early breast cancer then its nitrosamine appears in the relevant list of AIs (see the topic

Novartis pauses some trials of cancer drug Kisqali to fix manufacturing

The Swiss drugmaker said the stoppage is necessary to conform with new regulatory limits on nitrosamine, but will not affect commercial supply. 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. Kisqali 's API is ribociclib. N-nitroso -ribociclib impurity 1 is included in Appendix 1 as Category 3. [image] ribociclib

thank you!!

Christos