Novocure has been hit with a relatively rare “not approvable” letter from the FDA for its tumor-treating electric fields device.
The medtech was seeking a U.S. green light for its Optune Mya tech in patients with brain metastases from non-small cell lung cancer following stereotactic radiation.
But it was no dice from the FDA, which told Novocure that the “uncertainty around the degree of clinical benefit provided by Optune Mya prevented approval of the PMA application,” according to a company statement. The agency did not raise any safety concerns.
The setback follows the failure of Novocure’s Optune Gio device to improve brain cancer patients’ survival in a phase 3 clinical test.
Novocure tested the system in newly diagnosed glioblastoma and compared it to initiating TTFields therapy during the subsequent maintenance phase of treatment.
The trial failed to show significant improvement in the primary endpoint, which was overall survival compared to the maintenance arm. That device is licensed alongside temozolomide for newly diagnosed, supratentorial glioblastoma following maximal debulking surgery, and completion of radiation therapy together with a concomitant standard of care chemotherapy.
Analysts from Evercore ISI said in a note to clients that the news was not a surprise given previous debate over the product’s clinical efficacy.
“For some patients, the clinical rationale for prescribing rested around the quality of life benefit given slower intracranial progression ... but given no neurocognitive benefit, the bar was high (and would have faced payer pushback),” the firm wrote.
Novocure plans to meet with the FDA to seek approval options for the PMA application that would not require additional clinical studies.