FDA Panel Backs Device to Treat Brain Tumors
Advisory Panel Recommends Approval of NovoTTF for Treatment of Glioblastoma
New Hope for Glioblastoma Patients
The panel’s decision was delivered to an audience filled with glioblastoma patients, many of whom had traveled to the meeting to observe the deliberations.
“As a GBM [glioblastoma multiforme] patient myself, I’m here because I want to stay alive,” says Cheryl Broyles, who has had her tumor come back three times and says she has run out of treatment options.
Scott Johnson, an assistant softball coach from Minden, La., who was diagnosed with glioblastoma in June 2009, when he was 46, told the panel that an initial round of chemotherapy left him feeling exhausted and sick and took him away from his family during what may be his last months.
“When you don’t feel good, it’s hard to have hope,” Johnson says.
In his testimony, Johnson, who said he had traveled to the meeting at his own expense, had urged the panel to approve the device.
“I’ve worn the device for 14 months, and it has allowed me to continue my life,” Johnson says, who was granted access to the device through a clinical trial.
Depending on the size and location of the tumor, glioblastoma may be treated with surgery, radiation, chemotherapy, or a combination.
Treating Tumors With Electricity
The Novo TTF surrounds tumors with an intermediate-frequency electrical field that is thought to disrupt cell division, which, over time, may slow or even shrink the tumor.
The technology is approved in some European countries, but is still in late-stage clinical trials in the U.S. for glioblastoma and non-small-cell lung cancer.
“We look forward to working with the FDA to bring this novel, important therapy to patients as soon as possible,” says Asaf Danziger, CEO of Novocure, the maker of NovoTTF, in a news release.