BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE LUA

    MDR report key: 22661609 · Received July 30, 2025

    Report

    Report Number
    3010457505-2025-00552
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    June 19, 2025
    Report Date
    July 30, 2025
    Manufacturer
    NOVOCURE GMBH
    Product Code
    SDA
    UDI-DI
    07290107983235
    PMA / PMN Number
    P230042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT THE CONTRIBUTION OF THE ARRAYS TO THE SKIN IRRITATION AND PRURITUS WHICH REQUIRED MEDICAL INTERVENTION CANNOT BE RULED OUT. SKIN REACTION HAS BEEN REPORTED IN THE PIVOTAL EF-24 CLINICAL TRIAL FOR OPTUNE LUA TREATMENT FOR NSCLC (19% OVERALL IN THE TTFIELDS ARMS AND 2% OVERALL IN THE CONTROL ARMS).

    Description of Event or Problem · 0

    A 62-YEAR-OLD MALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) STARTED OPTUNE LUA THERAPY ON (B)(6) 2025. DURING A REVIEW OF A MEDICAL RECORD RECEIVED BY NOVOCURE, ON (B)(6) 2025, IT WAS NOTED DURING AN ONCOLOGY AND HEMATOLOGY FOLLOW UP APPOINTMENT ON (B)(6) 2025, THAT THE PATIENT DEVELOPED A GRADE II PRURITIC RASH ON THE CHEST, ATTRIBUTED TO OPTUNE LUA THERAPY. THE PATIENT WAS PRESCRIBED HYDROXYZINE HCL 25MG TWICE DAILY AS NEEDED, AND TOPICAL CORTICOSTEROIDS. FOLLOWING THE INITIATION OF THE TREATMENT, THE PRURITUS ASSOCIATED WITH THE SKIN REACTION REPORTEDLY IMPROVED. THE PHYSICIAN RECOMMENDED CONTINUING WITH THE SKIN CARE REGIMEN. ATTEMPTS TO CONTACT THE PRESCRIBING PHYSICIAN FOR FURTHER DETAILS WERE MADE, BUT NO RESPONSE WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514627 OPTUNE LUA OPTUNE LUA SDA NOVOCURE GMBH TFT9200 07290107983235

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention DENOSUMAB.| DEXAMETHASONE.| DOCETAXEL.| ENTECAVIR.| FINASTERIDE.| FLUCONAZOLE TOPICAL OINTMENT.| FLUCONAZOLE.| GABAPENTIN.| LOPERAMIDE.| METFORMIN.| PEMBROLIZUMAB.| SENNA.| TAMSULOSIN.| VALACYCLOVIR.