NovoCure said it won expanded indications from the FDA and a new CE Mark indication in the European Union for its brain-tumor treating Optune device.
The Optune device uses NovoCure’s “tumor treating fields,” which use low-intensity, intermediate-frequency alternating electric fields that limit cancer cell replication and kill cancer cells, the St. Helier, N.J.-based company said.
The FDA granted NovoCure clearance for its Optune in combination with prescribed temozolomide for the treatment of adult patients with newly diagnosed glioblastomas.
“Novocure is committed to helping patients with glioblastoma, and we are proud that Optune has been shown to offer patients such a significant improvement in both progression-free and overall survival. Glioblastoma is the most common form of primary brain cancer which, until now, has not seen any significant therapeutic improvements in over a decade. We’re thankful to the many patients, their caregivers and healthcare providers who partnered with us to develop a treatment that has finally led to a significant improvement in the outcomes for patients with glioblastoma,” CEO Asaf Danziger said in a press release.
The clinical study that supported the expanded indication reported that patients treated with the device and drug lived an average of 3 months longer than those who only took the drug, the company said. The new indication was reviewed under the FDA’s priority review program which provides expedited reviews of certain devices for life-threatening conditions.
Novocure said it obtained CE Mark approval in the European Union for the 2nd-generation version of the OpTune device.
The device has a “streamlined” design, novel signal generation technology and a TT field generator that is half the size of the 1st generation, the company said.
“Novocure’s 2nd generation Optune system is an important breakthrough for glioblastoma patients. The lightweight and streamlined design will make it easier for patients to adapt the treatment to their daily lives. The new device is an important step for patients receiving Optune therapy,” Dr. Martin Misch of Berlin, Germany’s Charité Universitatsmedzin said in a prepared statement.
Novocure said it intends to file a premarket approval supplemental application to the FDA for the next generation device, which is not yet cleared in the U.S.
Last week, Novocure priced its initial public offering, saying it looks to raise $165 million by floating 7.5 million shares at $22 a piece.
The company said it is also offering a 30-day underwriters option for an additional 1.1 million shares. NovoCure shares are slated to trade on the NASDAQ Global Select Market under the symbol “NVCR”.