ELCC 2018 | Off-label medication use in lung cancer

Federico Cappuzzo

With the increased use of next-generation sequencing (NGS) to identify mutations in patient’s own cancer cells, the off-label usage of non-approved drugs is on the rise. In this interview, Federico Cappuzzo, MD, PhD, of AUSL della Romagna, Ravenna, Italy, discusses the reasons why, and in what situations, his practice uses drugs off-label to treat lung cancer. This video was recorded in the 2018 European Lung Cancer Congress (ELCC), in Geneva, Switzerland.

Transcript (edited for clarity):

Usage of off-label agents in cancer, in general in oncology, and specifically in lung cancer is becoming very important, very relevant problem considering that we have several new targets that have been discovered. Unfortunately, we have few drugs approved against these targets so we frequently in our clinical practice have patients in which we discover molecular alterations, we have some preliminary data showing efficacy of a drug, but unfortunately the drug is not approved or reimbursed. Therefore, we need to ask for off-label usage.

Among these targets, certainly the situations for which we ask more frequently for off-label usage is represented by the discovery—, for example, of a BRAF mutation, we know that combination, for example, of trametinib and a BRAF inhibitor is very effective in this group of patients but at the present time, we don’t have a full reimbursement of these two drugs. So, when we detect a patient with such characteristics, we need to ask for off-label usage.

Another example is represented by HER2 mutations because we have clear evidence that trastuzumab based therapies are particularly effective in these patients but, at the present time, trastuzumab is approved only in breast cancer patients and not in lung cancer. For example, in MET deregulated patients, in patients with MET amplification or MET mutations, we have some preliminary data showing efficacy for crizotinib and again this drug is not yet available.
So, there are many situations in lung cancer therapy— particularly lung cancer therapy, we ask for off-label usage and probably this situation will be much more frequent in the near future, considering that now in routine practice, we are using next generation sequencing allowing us to detect several new molecular events for which we potentially can use the target therapies.

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