The US Food and Drug Administration (FDA) has rejected Novocure’s pre-market approval (PMA) application for its electrical fields treatment for brain metastases, citing “uncertainty” around the degree of clinical benefit provided by the therapy.
Novocure’s Optune Myadevice is designed to treat adult patients with brain metastases from non-small cell lung cancer (NSCLC) following stereotactic radiation. The system delivers electrical signals, dubbed tumour treating fields (TTFields), via wearable arrays placed directly on the skin. According to the Swiss company, these TTFields exert physical forces on the electrically charged components of dividing cancer cells, resulting in cell death.
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In the Not Approvable Letter from the FDA, Novocure said the agency expressed doubts over the clinical benefit provided by Optune Mya, with this being the primary reasoning its PMA was rejected. No safety concerns were noted by the agency.
The Swiss company now intends to evaluate the FDA’s feedback and meet with the agency to determine if there are any options that would “support approval” of Optune Mya’s PMA application that would “not require additional” clinical studies. Novocure conceded, however, that there would be “no assurance” that any ensuing discussions with the agency, or any future submissions regarding the PMA application, would result in an approval.
The FDA’s absence of doubt regarding Optune Mya’s safety profile should not come as a surprise. Novocure, which has been around since the year 2000, already holds FDA approvals for its other TTFields therapies that take a treatment approach that is effectively the same, albeit targeted at different tumour types.
Novocure’s first FDA approval for Optune Gio for recurrent glioblastoma treatment came in 2011. The company’s Optune Lua, indicated for use alongside PD-1/PD-L1 inhibitors or docetaxel in adult patients with metastatic NSCLC, received FDA approval in October 2024.
Most recently, Novocure made headlines for its receipt of FDA approval for Optune Pax in February 2026. The device, indicated for the treatment of locally advanced pancreatic cancer alongside gemcitabine and nab-paclitaxel, represented the first authorisation by the agency in this indication at the time, since Eli Lilly’s Gemzar (gemcitabine) chemotherapy drug in 1996.
