Hi to all, according to EMA ‘For finished products intended only for advanced cancer, N-nitrosamine impurities should be controlled according to ICH Q3 A(R2) and ICH Q3B(R2), as specified in the Q&A document to ICH S9.”.
My question is how to decide whether certain anticancer drug is for advanced cancer?
For some drugs, in label or SPC, it is not clearly described that this is for advanced cancer, but in the drug assessment report, sometimes it says that ‘Carcinogenicity studies are in general not required to support marketing for therapeutics intended to treat patients with advanced cancer. However, considering that life expectancy may be relatively long in some of these patients, in this particular case, there is a further need for carcinogenicity studies for this molecule’
‘The lack of dedicated fertility and early embryonic development studies is acceptable in accordance with the ICH S9 guide line as generally, no fertility study is warranted to support the treatment in patients with late-stage disease, also confirmed by the CHMP within the Scientific Advice procedure.’
In this case, can these molecules be regarded for advanced cancer? Thanks very much in advance.
Dear Lling,
I had similar experience in the past when submitting risk assessments. Advanced cancer drugs are also often considered as second- or third-line anticancer drug, meaning that if the primary therapy did not work, a second or third strategy is utlized by changing the molecule and specific target (“second-/third-Line”)
So if you look into SPC look for indication that this drug is only used after primary therapy did not succed.
From my own experience to ask a toxicologist if you are not sure which helps. If you know a toxicologist within your company, a I would approach and ask for help.
Tagging @conudel for any additional comment
ICH S9 seems to cover well what is considered advanced cancer. S9 says that “This guideline provides information for pharmaceuticals that are intended to treat cancer in patients with serious and life threatening malignancies. For the purpose of this guideline, this patient population is referred to as patients with advanced cancer.” They also say that advanced cancer is “whose disease is refractory or resistant to
available therapy, or where current therapy is not considered to be providing benefit”.
ICH S9 is the point of reference used by ICH M7 as well as the nitrosamine guidelines, so the above definition seems to be good enough in order to define what is considered advance cancer.
Thank you for pointing out and explaining in more detail