The U.S. Food and Drug Administration (FDA) has approved a new device for the treatment of brain cancer. The device is called the NovoTTF and is manufactured by NovoCure. TTF stands for tumor treating fields. It is a non-invasive device that utilizes electrical energy fields to battle cancer. There is no other cancer treatment like it out there today.
The FDA approved the NovoTTF to treat adults with aggressive glioblastoma multiforme, a common form of brain cancer, which has recurred or progressed despite chemotherapy and radiation treatment. This type of tumor is extremely resistant to traditional cancer treatments such as surgery, radiation, and chemotherapy. The FDA cautions that this new technology should only be utilized when other traditional protocols have failed.
Tumors grow when cancer cells are allowed to divide, creating more cancer cells. The NovoTTF weighs about six pounds and has four electrodes which are attached to the patient’s head. A white, bandage-like head covering is worn to protect the electrodes. Electrical signals are sent through the electrodes, creating electrical fields that can slow down or even reverse tumor growth by interrupting the cancer cell’s division process. Normal cells are not affected by the device.
The NovoTTF was approved for use in the United States after only a single trial. The study was based on 237 patients in both Europe and the United States. Participants had been diagnosed with advanced brain cancer and traditional treatments had been ineffective in treating their cancer. They were divided into two groups; one group was given chemotherapy and the other group used the NovoTTF. The latter group was connected to the device 20 hours each day.
Although the study reported a similar overall survival rate for patients in both groups, the FDA did note that there were some perks to utilizing the new device. When surveyed, the NovoTTF patients stated they felt they had a better quality of life. The battery-powered device is portable and can be carried in a shoulder bag, allowing participants to receive treatment while continuing on with their day to day life. Additionally, while they did report side effects such as scalp irritation, headaches, and convulsions, they did not experience the debilitating side effects of severe nausea, hair loss and fatigue reported by the chemotherapy patients.
Glioblastoma tumors are the deadliest form of brain cancer and affect about 10,000 people each year. Most people succumb to the disease within five years of being diagnosed and some in as little as six months, depending on the severity of the tumor. The NovoTTF gives patients an option for a treatment with a better quality of life. A new trial is being conducted which includes both brain and lung cancer patients.
The Food and Drug Administration (FDA) announced that it is rescinding its 2008 approval of the drug, Avastin, for the treatment of metastatic breast cancer. Federal health officials voted twelve to one to recommend the discontinuation of the use of Avastin to treat breast cancer. Genentech, the manufacturer of the drug and a subsidiary of Roche pharmaceutical company, has fifteen days to appeal the recommendation.
The FDA put Avastin on the fast-track for approval in 2008. They conditionally approved the drug based on initial clinical trials that showed the drug could prevent tumor growth for a longer span of time which provided the patient with a better quality of life. Fast-track approval requires that additional clinical trials substantiate the initial findings. However, each of the three following studies did not corroborate these findings. Furthermore, they indicated that the drug did not decrease tumor growth. Additionally, Avastin was found to cause life-threatening side effects not caused by other, more effective breast cancer drugs. These side effects include heart attacks, heart or kidney failure, nose bleeds, and bleeding of the intestine and stomach. The subsequent studies, combined with the severe adverse side effects have caused the FDA to rescind its previous approval of Avastin for breast cancer treatment.
Some doctors are disappointed in the FDA’s recommendation. They state there is definitely a population of women that the drug treats effectively, but they need more time to identify the specific tumors or patient population the drug will work on effectively. The FDA also conceded that if approval for Avastin is actually rescinded, it could be reinstated for specific groups of patients who it would benefit.
It is also worth mentioning that the FDA made their recommendation on the same day that the European Union’s Committee for Medicinal Products for Human Use (CHMP) praised the merits of the use of Avastin for breast cancer treatment when used in conjunction with another cancer drug called Paclitaxel. Utilizing a combination of medications in chemotherapy is common. It will be interesting to see if the data the FDA used to make their recommendation mirrors the data CHMP used to sing Avastin’s praises. If CHMP’s data proves that Avastin is effective for the treatment of metastatic breast cancer, Genentech could utilize CHMP’s data to win their appeal of the FDA’s decision.
Breast cancer patients currently taking the drug are not expected to experience any immediate affects from the FDA’s recommendation such as a limited supply. Doctors can still use their discretion to continue prescribing Avastin for breast cancer as an “off label” drug, like they do with many other drugs, since Avastin is currently approved for treating brain, kidney, lung, and colon cancers. However, many insurance companies will not cover “off label” drugs. At a cost of $8,000 a month, many patients may find the cost prohibitive.