Optune

Newly diagnosed glioblastoma (GBM) — in combination with temozolomide, after completion of maximal debulking surgery and concomitant chemoradiation; Recurrent glioblastoma — as a monotherapy in adult patients after surgical and radiation therapy options have been exhausted.

Usage: Continuous application for ≥18 hours per day (75%+ compliance) for maximum benefit
4 transducer arrays placed on shaved scalp according to individual treatment plan (based on MRI-derived tumor mapping)
Arrays replaced 1-2 times per week
Duration: Until tumor progression or for minimum 24 months for newly diagnosed GBM
Concurrent with temozolomide (newly diagnosed): standard temozolomide dosing continues while using Optune

Medical device: consists of a portable electric field generator, transducer arrays (4 arrays applied to shaved scalp), battery pack, and carrying case. Operating frequency: 200 kHz.

Active implanted medical devices (e.g., deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators). Skull defect (missing bone with no replacement). Known sensitivity to conductive hydrogels (ECG pad-type).

• Skin Toxicity: Dermatitis beneath transducer arrays in up to 43%. Most are Grade 1-2, mild-moderate contact dermatitis, heat rash, or skin breakdown. Treat with topical corticosteroids, rotate array placement, and brief treatment breaks (1-2 days).
• Skull Defect: Do not use if skull bone is missing without replacement.
• Heat Sensitivity: Device generates mild warmth; patients should avoid excessive external heat sources to array areas.
• Electrical Hazards: Do not use with other electrically powered medical devices on the head.

Skin irritation/dermatitis (43%), headache (14%), fatigue (9%), muscle twitching under arrays (4%), discomfort at array sites (common), electric sensation/tingling under arrays (common). No systemic adverse effects — device is local therapy.

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Optune (TTFields) delivers low-intensity (1-3 V/cm), intermediate-frequency (200 kHz) alternating electric fields to the tumor region via transducer arrays on the scalp. TTFields exert anti-mitotic effects by two mechanisms: (1) During metaphase, the fields exert directional forces on polar molecules (especially tubulin), disrupting mitotic spindle assembly and preventing proper chromosome alignment. (2) During cytokinesis, the non-uniform electric field generated at the cleavage furrow exerts dielectrophoretic forces on intracellular organelles, disrupting cell division and causing mitotic catastrophe and apoptosis. TTFields preferentially affect dividing cells while sparing quiescent cells.

Not applicable — Optune is a medical device, not a pharmaceutical agent. TTFields are delivered continuously via transducer arrays on the scalp at 200 kHz, 1-3 V/cm. Electric field intensity is highest near the arrays and attenuates with depth. Computational modeling based on MRI-derived head models is used to optimize array placement for maximum field delivery to the tumor region. There is no systemic absorption or metabolism.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• EF-14 — TTFields + temozolomide vs. temozolomide alone in newly diagnosed glioblastoma. Phase III, n=695.
  🔬 NCT00916409 ↗ 📄 Primary Publication ↗

Optune has FDA-approved indications across the following cancer types covered on PipelineEvidence: