FDA Rejects Novocure Application for Optune Mya

Novocure said the FDA has declined to approve its application for Optune Mya, a treatment for adults with brain metastases from non-small cell lung cancer following stereotactic radiation. The regulator cited uncertainty about the degree of clinical benefit, while raising no concerns about the treatment’s safety profile, the Swiss company said Monday.

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Novocure said it received a “not approvable” letter in response to its premarket approval application. The company is assessing the FDA’s feedback and plans to meet with the regulator to discuss whether any path to approval is available without additional clinical studies.

The company cautioned that there is no assurance discussions with the FDA or any future submissions related to the application will result in approval.

Novocure shares fell 2.4% to $12.96 in premarket trading on Nasdaq. At Friday’s close, the stock was down 19% over the previous three months, leaving its year-to-date gain at 2.7%.

FDA Rejects Novocure Application for Optune Mya

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