FDA Panel Backs Device to Treat Brain Tumors
Advisory Panel Recommends Approval of NovoTTF for Treatment of Glioblastoma
Split Vote on Effectiveness continued...
The trial included 237 patients who were randomly assigned to receive either the NovoTTF or chemotherapy.
But in analyzing their data, the researchers did not consider patients who could not complete at least four weeks of therapy with the NovoTTF. Some of those were among the sickest patients in the trial, and panel members felt that their exclusion, along with design problems, likely biased the results in favor of the new device.
Overall, the study found that patients survived about as long using the NovoTTF as they did with chemotherapy, with significantly fewer side effects. But many felt that result wasn’t definitive.
“There’s still a need for more systematic assessment,” Lisanby says.
She voted that the device was not proven to be effective and was one of two voters who abstained on the question of whether the benefits outweighed the risks.
“I didn’t know how to make a ratio between safety and efficacy when neither was well measured,” she says.
Study researchers reported very few side effects while using the NovoTTF. A skin rash, which developed beneath electrodes, was the most common problem and it could be treated with topical steroids.
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.