Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

"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."

Source: Bloomberg

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!

3 Responses to “Merck KGaA reviewing cardiac data for Erbitux in lung cancer trials”

  1. sgcox

    Does it mean targeting EGFR has similar cardiac effects as targeting EGFR2(HER2)? I was under impression Her2 is the major isoform in heart.

  2. MaverickNY

    Good question. It might be possible. Oddly, I was reading this paper earlier today about neuregulin, EGF and the heart:
    But the confounding thing is that I don’t recall any cardiac problems with other cancers treated with Erbitux such as colon and head & neck cancers. We don’t know for sure that the cardiac effects are confirmed in lung cancer either, only that the EU HA have asked for an analysis. It will be interesting to see what the analysis reveals.

  3. Melissa

    Do you believe that this safety issue in lung cancer is similar to the issue that resulted in stopping the adj CRC Erbitux trial N0147?

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