BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE LUA

    MDR report key: 21705214 · Received March 27, 2025

    Report

    Report Number
    3010457505-2025-00471
    Event Type
    Injury
    Date Received
    March 27, 2025
    Date of Event
    March 6, 2025
    Report Date
    March 27, 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 CONTRIBUTION OF THE ARRAY PLACEMENT TO THE SKIN IRRITATION CANNOT BE RULED OUT. A RISK FACTOR FOR SKIN IRRITATION IN THIS PATIENT INCLUDES CONCOMITANT PEMBROLIZUMAB (RASH, ITCHING, SKIN BLISTERING OR PEELING ARE COMMON ADVERSE REACTIONS. SOURCE: PEMBROLIZUMAB PRESCRIBING INFORMATION). 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 75-YEAR-OLD FEMALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) STARTED OPTUNE LUA THERAPY ON (B)(6) 2025. ON MARCH 06, 2025, NOVOCURE WAS INFORMED THAT THE PATIENT EXPERIENCED A SKIN REACTION, DESCRIBED AS ITCHING ON HER BACK AFTER THE SECOND DAY OF WEARING THE TRANSDUCER ARRAYS. THE FRONT OF HER TORSO REPORTEDLY REMAINED UNAFFECTED. IT WAS NOTED THAT THE PATIENT HAD APPLIED A SKIN PREPARATION AND TOOK UNSPECIFIED ORAL ANTIHISTAMINES. THE PATIENT REMAINED ON OPTUNE LUA THERAPY. 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
    2373943 OPTUNE LUA OPTUNE LUA SDA NOVOCURE GMBH TFT9200 07290107983235

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention ALBUTEROL SULFATE.| APIXABAN.| BUDESONIDE/FORMOTEROL.| CARVEDILOL.| FUROSEMIDE.| IPRATROPIUM BROMIDE/ALBUTEROL SULFATE.| LIDOCAINE GEL.| LOSARTAN POTASSIUM.| METHOCARBAMOL.| ONDANSETRON.| PEMBROLIZUMAB.| POTASSIUM CHLORIDE.