Brussels – Innovative treatments for cancer don’t reach the patients straight away. To reduce this problem, official treatment guidelines play an important role, but they lack speed in adding new therapeutic options. What’s more, life-saving treatments may simply not end up in treatment guidelines if they don’t have a commercial sponsor to promote their use. The Anticancer Fund tackles the issues in an article published in Nature Reviews Clinical Oncology.

Patients with cancer are gaining access to an expanding number of new therapeutic options. To help clinicians to navigate this rapidly evolving landscape, treatment guidelines, or reviewed recommendations on how to treat the disease, are becoming increasingly essential. But amending these guidelines in a timely and comprehensive manner seems far from obvious.

In an article published online in Nature Reviews Clinical Oncology, Gauthier Bouche, Director of Clinical Research at the Anticancer Fund, and Lydie Meheus, Managing Director at the Anticancer Fund, raise the alarm. The article is entitled “Ensuring completeness and timeliness of cancer treatment guidelines” and was released Friday the 20th of May 2022.

The most consulted cancer treatment guidelines by clinicians today include those of the National Comprehensive Cancer Network (NCCN) in the United States and those of the European Society for Medical Oncology (ESMO) in Europe.

In the article, the researchers of the Anticancer Fund demonstrate that new uses of 4 off-patent drugs, supported by results of randomised trials, are not systematically integrated in the guidelines, and consequently prevent patients from accessing life-saving treatment options.

The example of sorafenib

Take for instance sorafenib, one of the 4 off-patent drugs. Sorafenib is normally used to treat liver cancer, but has shown to be also effective in patients with a form of leukaemia. As sorafenib is available as a generic drug, no company is promoting this new effective use. Thanks to the Anticancer Fund, which managed to include sorafenib into the NCCN guidelines for the treatment of leukaemia, American clinicians now see it listed and American patients can get the drug, but no solution has yet been found for European patients.

“Though I understand there can be a reasonable delay between results availability and inclusion into the guidelines, it’s unbearable that major results - such as for sorafenib improving survival by 20%! - are ignored or missed by the makers of the guidelines“, says Gauthier Bouche.

“Allowing everyone to submit relevant clinical evidence for integration into the guidelines may prevent this from happening. We believe we are touching on something crucial that deserves more attention, especially from decision makers in Europe. They can take measures to assure that all positive clinical trial results are thoroughly assessed by the regulator, the European Medicines Agency (EMA)”, adds Lydie Meheus.

A simple solution to ensure that all European patients ultimately can get the drug, would be to add the new indication to the drug label after assessment by the EMA, but the agency doesn’t have this competence under the current pharmaceutical legislation. So, it’s up to decision-makers to adapt the legislation. And this is the moment, as the EU’s general pharmaceutical legislation is being revised as we speak.

Read the article here.