Innovative Mesothelioma Therapy Receives Special FDA Approval
When it comes to bringing drugs and medical devices to market, pharmaceutical companies have to jump through a lot of hoops. There are layers upon layers of clinical trials and testing that need to be done before the U.S. Food and Drug Administration provides its approval.
Yet, when it comes to rare and difficult diseases, there are special rules which allow for shortcuts, and that is frequently the case with treatments for malignant mesothelioma. T
his special mechanism was recently used to provide Humanitarian Use Device (HUD) status to a new protocol that’s been created by Novocure: their Tumor Treating Fields system has just gone through the first step in what they hope will lead to a Humanitarian Device Exemption, which would allow the device to be offered for widespread mesothelioma patient use.
Patients who have been diagnosed with malignant mesothelioma face remarkable challenges. The disease, which is caused by exposure to asbestos, has an extremely challenging prognosis and most patients do not live more than two years from the time of diagnosis.
Novocure’s Tumor Treating Fields device offers a novel approach that emits low-intensity electricity via a portable device that patients are able to wear throughout the day. The electricity prevents cancerous cells from multiplying by interfering with proteins involved in cell division.
It has been shown to offer significant improvements in patient longevity and in slowing tumor progression when combined with the use of either Alimta (pemetrexed) or Platinol (cisplatin) plus Paraplatin (carboplatin).
Speaking of their hopes for the device’s use in the future, Asaf Danziger, chief executive officer of Novocure said, “We believe that treatment with TTFields affects fundamental aspects of cell division and may have broad applicability across a variety of solid tumors. We are pleased to receive HUD designation as it is a major step towards a second regulatory approval for TTFields in the United States.”
The device was tested in a non-randomized, open-label Phase 2 trial on 80 patients whose mesothelioma was newly diagnosed and identified as being unable to be removed via surgery.
Reports on the study showed that nearly 80 percent of those who received the treatment survived at least one year compared to only 50 percent who lived that long without the combination treatment. Similar improvements were shown in the median time it took before disease progression.
Even patients whose mesothelioma has been identified as extremely aggressive have options available, if you just know where to look. The Patient Advocates at Mesothelioma.net are here to provide you with the resources you need to help you in your time of crisis. Call us today at 1-800-692-8608 to learn more.FREE Mesothelioma Packet