"Merck KGaA is reviewing heart risks of its tumor-fighting Erbitux drug in several types of cancer after European regulators asked for more information on the treatment’s safety.
The European Medicines Agency requested the review after rejecting Erbitux for use in lung cancer patients, according to a report published online on March 12. The drug regulator identified an “increased incidence of cardiac events” in lung cancer patients age 65 years or more, in particular high-risk patients with a history of heart problems."
This was an interesting snippet of news that I saw in the mass of alerts this morning, and no obvious press release from any of the companies involved with the drug, Merck KGaA (in Europe), BMS or Imclone (US partners).
Part of the problem here is that many people with lung cancer also tend to have cardiac co-morbidities and thus the two may go hand in hand. To be fair, similar side effects have not apparently been reported in other cancers, such as colon cancer.
If the analysis reveals negative findings, then it may lead to changes in the prescribing information, which will not be good news. Of course, the company are hopeful that will not happen, because changes in the EU labelling for Erbitux (cetuximab) may subsequently impact the US one too.
Merck are already having a rough week on the issues management and communications front with the suspension of the Stimuvax trials after a patient being treated with the vaccine developed encephalitis. At least the current issue didn't get reported on a Friday!