FDA approves new medical device for form of brain cancer

The U.S. Food and Drug Administration recently approved the NovoTTF-100A System, a new device to treat adults with glioblastoma multiforme (GBM) that recurs or progresses after receiving chemotherapy and radiation therapy.

Brain tumors are the growth of abnormal cells in the brain tissue. According to the National Cancer Institute, each year about 19,000 people in the United States are diagnosed with primary brain cancers. In 2010, there were 13,140 deaths from brain and other nervous system cancers in the United States.

GBM is the most common primary brain cancer. The brain tumor is highly resistant to standard treatments such as surgery, radiation and chemotherapy.

When using the NovoTTF-100A System, a health care professional places electrodes on the surface of the patient’s scalp to deliver low-intensity, changing electrical fields called “tumor treatment fields” (TTFs) to the tumor site. The unique shape and electrical characteristics of dividing tumor cells make them susceptible to damage when exposed to TTF, which could stop tumor growth. 

The device is portable and can be powered with batteries or plugged into an electrical outlet. Patients can use the device at home, allowing them to continue their normal daily activities. 

“Recurrent glioblastoma multiforme is a devastating form of brain cancer that often eludes standard treatments,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The agency’s approval of the NovoTTF-100A System shows FDA’s commitment to innovative new devices that provide patients with other treatment options.”

The FDA based its approval of the NovoTTF-100A System on results from a single international clinical study in 237 patients with recurrent GBM or with GBM that hadn’t responded to traditional therapy. Patients in the study were randomly assigned to receive either the NovoTTF-100A System or chemotherapy treatment. 

The study showed comparable overall survival rates between patients treated with the NovoTTF-100A System and those who underwent chemotherapy.

Patients treated with the NovoTTF-100A System experienced a slightly higher incidence of neurological side effects including convulsions and headaches compared to patients receiving chemotherapy. However, they did not experience the significant side effects associated with chemotherapy, including nausea, anemia, fatigue and serious infections. 

A survey of patients in the study suggested an improved quality of life in the NovoTTF-100A recurrent GBM patients compared to patients receiving chemotherapy.

Patients should not use the NovoTTF-100A System if they have an implanted medical device or a skull defect, or have a known sensitivity to conductive hydrogels, such as those used with electrocardiograms. The NovoTTF-100A System is not intended to be used in combination with other cancer treatment. The device should only be used after other treatments have failed.

The NovoTTF-100A System is made by Novocure of Portsmouth, N.H.

SOURCE: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm251669.htm

Bar-coding for medicines would be mandatory says DCGI

PATIALA:  The Drug Controller General of India (DCGI) has proposed to make it mandatory for medicines intended for domestic supply to also bear barcodes.  

This was disclosed by Dr. Surinder Singh, Drug Controller General of India (DCGI), Ministry of Health & Family Welfare, Govt. of India while addressing a press conference at Swift School of Pharmacy, a pharmaceutical institute of Ind Swift Group at Ghaggar Saria in this district on Saturday.

He said that, Commerce ministry unveiled an ambitious scheme to add serial numbers to all exported medicines - via the printing of  S1-compliant 2D barcodes on primary packaging and 1D or 2D codes on secondary packaging in this year.

DCGI added that we have more sweeping proposal for the addition of serial numbers to the unit-pack level on all medicines destined for use in the

domestic market. 

The unique identifier (UID) number will also be printed on the pack in a user-readable format so that it can be sent via text message to a centralised phone number for authentication, he added

He said that pharmaceutical industry has reservations about the cost effectiveness. The president of Indian drug manufactures’ association – NR Munjal who was also present at the press conference said that total cost of the printing of 2D barcodes will add another burden on the industry and cost of drug will escalate by about 40 percent which will certainly  has burden on consumer. 

Earlier Dr. Surinder Singh laid the foundation stone of   Post Graduate & Research Wing of Swift School of Pharmacy, a pharmaceutical institute of Ind Swift Group. The President of Swift School of Pharmacy, Dr Gopal Munjal also present on the occasion. 

The institute is situated on GT road and on about 10 kilometers from Rajpura in Patiala district towards Ambala  Dr. G.N. Singh, Secretary-cum-Scientific Director, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Govt. of India, laid the foundation stone of Animal House. 

Professor, Dr. V. J. Dhar, Director of Swift School of Pharmacy, referring to the WHO’s concern on Antibiotic resistance, stressed upon the importance of quality in pharma education, which will also result in overcoming practices like supply of spurious drugs, wrong drug combinations and irrational therapies.