BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE LUA

    MDR report key: 22824911 · Received August 18, 2025

    Report

    Report Number
    3010457505-2025-00565
    Event Type
    Injury
    Date Received
    August 18, 2025
    Date of Event
    July 22, 2025
    Report Date
    August 18, 2025
    Manufacturer
    NOVOCURE GMBH
    Product Code
    SDA
    UDI-DI
    07290107983235
    PMA / PMN Number
    P230042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 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).

    Description of Event or Problem · 0

    A 75-YEAR-OLD MALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) BEGAN OPTUNE LUA THERAPY ON (B)(6) 2025. ON (B)(6) 2025, NOVOCURE RECEIVED A MEDICAL RECORD DATED (B)(6) 2025, INDICATING THAT THE PATIENT TEMPORARILY DISCONTINUED OPTUNE LUA THERAPY DUE TO PRURITIC MACULOPAPULAR RASH GRADE 3, DESCRIBED AS SIGNIFICANT ITCHY RASH ON THE CHEST AND UPPER BACK. THE PATIENT WAS INITIATED ON MEDIUM TO HIGH POTENCY TOPICAL STEROIDS. AT A FOLLOW UP APPOINTMENT ON (B)(6) 2025, IT WAS NOTED THAT OPTUNE LUA THERAPY HAD NOT YET RESUMED. HOWEVER, THE RASH IMPROVED, WITH GRADE 1 RASH REMAINING, LOCALIZED TO THE CENTRAL CHEST AROUND THE STERNUM AND UNDERNEATH THE RIGHT RIB CAGE. MILD ERYTHEMA WAS STILL PRESENT. THE PATIENT HAD BEEN PRESCRIBED TRIAMCINOLONE ACETONIDE 0.5% TOPICAL CREAM AND AMOXICILLIN 875 MG/POTASSIUM CLAVULANATE 125MG, TO BE TAKEN TWICE DAILY FOR FOURTEEN DAYS. ON (B)(6) 2025, THE PATIENT INFORMED NOVOCURE OF CONTINUED SKIN IRRITATION, INCLUDING OPEN AREAS ON THE TORSO. THE PATIENT REPORTED THAT HE HAD BEEN PRESCRIBED UNSPECIFIED ANTIBIOTICS AND OINTMENT. ON (B)(6) 2025, THE PRESCRIBING PHYSICIAN REPORTED THAT THE PATIENT TEMPORARILY DISCONTINUED OPTUNE LUA THERAPY ON (B)(6) 2025, DUE TO THE DEVELOPMENT OF A RASH, ALTHOUGH IMMUNOTHERAPY WAS CONTINUED. THE RASH RESOLVED COMPLETELY BY (B)(6) 2025, AND OPTUNE LUA THERAPY WAS RESUMED. HOWEVER, ON (B)(6) 2025, THE RASH RECURRED, PROMPTING ANOTHER THERAPY INTERRUPTION. THE PATIENT WAS PRESCRIBED AMOXICILLIN FOR TWO WEEKS. BY (B)(6) 2025, THE RASH HAD IMPROVED BUT WAS NOT FULLY RESOLVED. THE PATIENT WAS ADVISED TO APPLY TRIAMCINOLONE CREAM AND REMAIN OFF THERAPY. ON (B)(6) 2025, FOLLOWING A RESUMPTION OF OPTUNE LUA THERAPY, THE RASH WORSENED. BETAMETHASONE CREAM WAS PRESCRIBED, AND THERAPY WAS AGAIN DISCONTINUED. THE PRESCRIBING PHYSICIAN CONFIRMED THAT THE RASH WAS ATTRIBUTABLE TO OPTUNE LUA THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543223 OPTUNE LUA OPTUNE LUA SDA NOVOCURE GMBH TFT9200 07290107983235

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention ALBUTEROL| ATORVASTATIN| CLOPIDOGREL| DEXAMETHASONE| EZETIMIBE| LEVOTHYROXINE| LIDOCAINE-PRILOCAINE TOPICAL CREAM