FDA approves Novocure’s second-gen brain cancer device

The FDA approved Novocure’s ($NVCR) PMA supplement application for its second-generation Optune system to treat glioblastoma. The device is a smaller, lighter follow-up to its Tumor Treating Fields delivery system, which will be more convenient for patients to use.

The original Optune got the FDA nod in 2011 to treat adults with glioblastoma that recurred after chemotherapy, and secured the coveted approval for use as a first-line treatment in October 2015. The St. Helier, Jersey Isle-based company filed the PMA supplement for the second-gen device in January this year.

The wearable device delivers noninvasive therapy via four adhesive patches to the region of the brain where the tumor is located. It is used alone for patients with recurrent glioblastoma, while it is used in combination with the chemotherapy drug temozolomide in patients with newly diagnosed glioblastoma.

The company recommends patients wear Optune for at least 18 hours a day. At 2.7 pounds, the second-gen device is less than half the size of the original, and includes additional new features to improve comfort for the patient. It has a “No-Stop Swap” feature that allows patients to change power source or replace batteries without disrupting therapy as well as a new battery indicator that displays power and alerts patients when to change the batteries.

“The second generation Optune system was designed to be more convenient and to make it even easier for patients to incorporate treatment with TTFields into their lives,” said Mike Ambrogi, Novocure chief operating officer, in the statement. “We have received positive feedback from our second generation Optune patients in Europe, and we are excited to roll out our new device to patients in the United States.”

In the meantime, Novocure is also working on applying its TTFields tech to pancreatic cancer. In January, it reported results from a Phase II study of 20 pancreatic cancer patients with inoperable tumors and who had not received chemotherapy or radiation therapy. The treatment improved survival and response rate, the company said at the time.

- here's the statement

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