A 67-year-old woman treated for lung cancer died in France after a serious skin reaction linked to taking her treatment, the Medicines Agency informs.
It’s a worrying security information published by the National Medicines Agency on January 11. The cause is toxic epidermal necrolysis (also called “Lyell syndrome”). fatal was reported in a 67 year old woman treated by adagrasib (Krazati®) for cancer of the lung (not small cell). Epidermal necrolysis is one of the forms the most serious allergic manifestationsmainly caused by taking medications and characterized by brutal destruction of the epidermis and mucous membranes (oral, vaginal, conjunctiva, etc.). An analysis made it possible to identify four other cases of serious skin reactions and one non-serious case of “skin toxicity” related to the use of adagrasib alone or in combination. “Additional investigations are underway to evaluate this signal and take appropriate measures” inform theANSM.
These skin symptoms should alert
Epidermal necrolysis is very rare, recalls the High Authority of Health -2 to 6 cases per million inhabitants per year- and is a vital emergency. Patients affected by taking adagrasib, as part of a compassionate access program or clinical trials, should consult a doctor if they have any concerns. skin toxicity symptomsnotably :
- A pain generalized skin;
- A rash that spreads quickly;
- Skin blisters and/or large areas of peeling skin;
- Inflammation and then hemorrhagic erosions on the mucous membranes, including the mouth, nose, eyes, anus and genital areas.
Necrosis can begin insidiously and unspecifically. This should be considered in the face of any beginning mucosal damage (conjunctivitis, pharyngitis) feverish after the recent introduction of a medication, especially a high risk medication like adagrasib. Treatment with adagrasib should be immediately discontinued if Stevens-Johnson syndrome is suspected (SJS) or Lyell’s or bullous lesions and the patient must be referred urgently to a dermatologist. Treatment should be permanently stopped if the diagnosis of SJS or Lyell’s is confirmed.
The drug Krazati® benefits from a marketing authorization in the United States in patients with advanced non-small cell lung cancer carrying the KRAS G12C mutation. On November 9, 2023, the European Committee for Medicinal Products for Human Use (CHMP) issued a positive review for a placing the drug on the European market, in the same indication. The opinion of the European Commission is pending. Currently, adagrasib is available in France as part of a compassionate access program. Compassionate use programs allow the therapeutic use of medicines without marketing authorization for dead end patients therapeutic. The drug agency has temporarily suspended new treatment initiations with adagrasib under these programs.