BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE LUA

    MDR report key: 22882042 · Received August 25, 2025

    Report

    Report Number
    3010457505-2025-00574
    Event Type
    Injury
    Date Received
    August 25, 2025
    Date of Event
    July 5, 2025
    Report Date
    August 25, 2025
    Manufacturer
    NOVOCURE GMBH
    Product Code
    SDA
    UDI-DI
    07290107983235
    PMA / PMN Number
    P230042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE'S MEDICAL OPINION IS THAT A CONTRIBUTION OF THE TRANSDUCER ARRAYS TO THE SKIN INFLAMMATION/IRRITATION AND HYPERSENSITIVITY THAT 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). HYPERSENSITIVITY WAS NOT REPORTED IN THE PIVOTAL EF-24 CLINICAL TRIAL FOR OPTUNE LUA TREATMENT FOR NSCLC. HYPERSENSITIVITY HAS BEEN REPORTED APPROXIMATELY 403 TIMES IN THE COMMERCIAL PROGRAM TO DATE, 12 WERE ASSESSED AS SERIOUS AND RELATED TO DEVICE USE.

    Description of Event or Problem · 0

    A 72-YEAR-OLD MALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) BEGAN OPTUNE LUA THERAPY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT'S SPOUSE REPORTED TO NOVOCURE THAT THE PATIENT TEMPORARILY DISCONTINUED OPTUNE LUA THERAPY FROM JULY 10 TO (B)(6) 2025, DUE TO THE DEVELOPMENT OF A SEVERE BLISTERING RASH ON THE TORSO FROM THE ARRAYS. ADDITIONALLY, THE PATIENT EXPERIENCED A MILD RASH LOCALIZED TO THE ARMS AND NECK, ATTRIBUTED TO IMMUNOTHERAPY. THE HEALTHCARE PROVIDER (HCP) PRESCRIBED 2.5% HYDROCORTISONE CREAM; REPORTEDLY THE PATIENT HAD ALREADY BEEN USING A SKIN PREPARATION PRODUCT. AT THE TIME OF THE REPORT, THE RASH PERSISTED ON THE TORSO BUT HAD SIGNIFICANTLY IMPROVED, ALLOWING THE PATIENT TO RESUME OPTUNE LUA THERAPY. ON (B)(6) 2025, THE SPOUSE REPORTED THAT THE PATIENT HAD BEEN STRUGGLING WITH ONGOING SKIN IRRITATION SINCE STARTING OPTUNE LUA THERAPY, WITH A SEVERE RASH DEVELOPING AFTER THREE DAYS OF THERAPY INITIATION. THE PATIENT WAS SUBSEQUENTLY PRESCRIBED HYDROCORTISONE CREAM, DIPHENHYDRAMINE, AND STEROIDS. THE HCP SUSPECTED THE PATIENT DEVELOPED AN ALLERGIC REACTION TO THE ARRAYS. AS DESCRIBED IN THE REPORT, THE RASH WAS PAINFUL AND PRURITIC, WITH OPEN, PURULENT SORES LOCATED ON THE FRONT AND BACK OF THE TORSO BENEATH THE ARRAYS. THE PATIENT DECIDED TO PERMANENTLY DISCONTINUE OPTUNE LUA THERAPY. THE PRESCRIBING PHYSICIAN WAS CONTACTED FOR FURTHER DETAILS, ALTHOUGH NO REPLY WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2486688 OPTUNE LUA OPTUNE LUA SDA NOVOCURE GMBH TFT9200 07290107983235

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention ALBUTEROL SULFATE.| FLUTICASONE FUROATE-VILANTEROL.| FLUTICASONE PROPIONATE-SALMETEROL.| METHYLPREDNISOLONE.| ONDANSETRON.