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news.The US Food and Drug Administration (FDA) has accepted for filing and review as well as granted priority review status for Novocure's premarket approval (PMA) application for Optune.
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The PMA application seeks approval for tumor treating fields (TTFields), in combination with temozolomide chemotherapy, as a first-line treatment for glioblastoma (GBM).
The submission of PMA is based on the data from EF-14, a randomized, Phase III trial comparing TTFields plus temozolomide to temozolomide alone in newly diagnosed glioblastoma.
Novocure CEO Asaf Danziger said: "The FDA has been extremely responsive in working with Novocure on the Optune PMA supplement and we appreciate their partnership.
"We are very pleased to have received priority review and are fully committed to working closely with the FDA to ensure that Optune is approved as quickly as possible for newly diagnosed GBM.
"The FDA’s acceptance of the PMA supplement application for Optune is a very important milestone for Novocure and an even more important milestone for patients suffering from GBM who are in need of new and effective treatments."
The pre-specified, interim analysis from the Phase III trial showed that the percentage of patients alive at two years in the TTFields together with temozolomide arm was 48% higher than in the temozolomide alone arm.
In the trial, patients treated with TTFields together with temozolomide showed a significant reduction in risk of progression or death compared to temozolomide alone.