Novocure Receives FDA Approval for Second Generation Optune System

Novocure announced that the U.S. Food and Drug Administration (FDA) approved its premarket approval (PMA) supplement application for Novocure’s second generation Optune system. The new smaller, lighter Tumor Treating Fields (TTFields) delivery system is now available to glioblastoma (GBM) patients in the United States.



Novocure designed the second generation Optune system to make treatment with TTFields more convenient and manageable for GBM patients. The new model features a TTFields generator that is less than half the weight and half the size of the generator in the first generation Optune system. Including its battery, the second generation Optune system weighs 2.7 pounds, compared to the first generation system that weighs 6 pounds. Novocure reduced the size and weight of Optune by utilizing novel digital signal generation technology. Additional improvements include: easy-grip texture that allows for better handling; a battery indicator that displays power and alerts patients when to change the battery; a light-detecting sensor that auto-dims the device and charger in the dark; and a “No-Stop Swap” feature that enables patients to change batteries or power source without disrupting delivery of TTFields therapy.

Novocure started offering the second generation Optune system to patients in Germany in October 2015 and has since made it available to all new patients in Europe.

“From the start, Novocure’s mission has been to improve the lives of cancer patients,” said Mike Ambrogi, Novocure’s Chief Operating Officer. “The second generation Optune system was designed to be more convenient and to make it even easier for patients to incorporate treatment with TTFields into their lives. We have received positive feedback from our second generation Optune patients in Europe, and we are excited to roll out our new device to patients in the United States.”

Novocure will offer existing Optune patients in the United States the opportunity to convert to the second generation Optune system over the next several weeks. All new patients will receive the second generation Optune system.

“We are happy to receive FDA approval of our second generation Optune system,” said Asaf Danziger, Novocure’s Chief Executive Officer. “We believe the improvements incorporated into the second generation Optune system will make a big difference to the patients and families who face this devastating disease every day. We will continue to work to improve our technology and patient experience.”

A press release can be found from Novocure website.

Roche receives EU approval of Avastin in combination with Tarceva for patients with a specific type of advanced lung cancer

Roche announced that the European Commission has approved the use of Avastin® (bevacizumab) in combination with Tarceva® (erlotinib) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR)-activating mutations.

The pivotal phase II JO25567 study showed a statistically significant 46 percent relative reduction in the risk of disease progression or death (median PFS: 16.0 months versus 9.7 months; [HR]=0.54, p=0.0015) for people treated with the combination of Avastin plus Tarceva compared to Tarceva alone. Avastin and Tarceva each target pathways which are known to be key drivers in the development and growth of tumours. The beneficial effect of Avastin plus Tarceva is supported by results of other clinical studies which showed the combination was effective and tolerable.

“The combination of Avastin and Tarceva represents a new standard of care for patients with this type of lung cancer,” said Sandra Horning, M.D., Chief Medical Officer and Global Head of Product Development. “This approval provides physicians in Europe with a powerful combination therapy that can significantly extend progression-free survival beyond one year, representing important progress for a group of patients who typically face a poor prognosis.”

Each year, an estimated 23,000 Europeans are diagnosed with non-squamous NSCLC with EGFR-activating mutations, the equivalent of more than 60 diagnoses every day.4-8 NSCLC is the most common type of lung cancer, the leading cause of cancer-related death in Europe and across the world. Of all cancers, lung cancer has the greatest global economic and societal impact, making improvements in outcomes for patients with lung cancer a key global healthcare challenge.

More information can be found from Roche website.

Tailor-Made Radiation Therapy in Cancer Treatment

Radiation therapy is one of the most essential elements in cancer treatment. But properly planning radiation therapy is a highly complex task. Fraunhofer mathematicians have joined an alliance with medical physicists and physicians to improve the therapy planning process. In doing so they have helped improve patient‘s chances of recovery.


Professor Karl-Heinz Küfer was amazed when he saw for the first time how radiation therapy for cancer patients was planned: »The processes physicians and physicists used in jointly planning radiation therapy reminded me of looking for objects in a dark room, groping around and then trying again,« recalls Küfer, a mathematician at the Fraunhofer Institute for Industrial Mathematics ITWM in Kaiserslautern, Germany. He recognizedthe potential for improvement and got together with physicians, physicists and information scientists to develop an alternative solution. The result was an interactive and easy-to-operate software product. It shortens the duration of radiation therapy planning, makes finding a good balance between therapy potentials and possible side-effects easier and ultimately increases the patient‘s chances of recovery.Every year in Germany approximately 483,000 people are diagnosed with cancer, with 222,000 cases ending fatally. This makes cancer Germany‘s second most common cause of death. Radiation therapy is used to treat more than half the cases. The radiation used damages cell DNA and thus inhibits their cell division or results directly in the death of the cell.

The objective of the therapy is to kill tumor cells while protecting healthy tissue. In the past the physician formulated his wishes and the radiation physicist turned these demands into a therapy plan. If the physician wasn‘t satisfied with the results, the physicist did follow-up work. Gradually the optimum solution was found. »The new thing about the mathematical approach is that from the very beginning a variety of solutions is calculated; the physician can then choose the best solution for the patient,« explains Professor Jürgen Debus, radio-oncologist at Heidelberg University Hospital, who tested the developed software in clinical use. In order to improve the process, Fraunhoferresearchers Karl-Heinz Küfer, Dr. Michael Bortz, Dr. Alexander Scherrer, Dr. Philipp Süss and Dr. Katrin Teichert considered therapy planning as a multi-criterion optimization task, in this case a balanced compromise involving around ten to fifteen in part contradictory planning goals. »The principle of the Pareto solution is a better concept here than the previous trial-and-error strategy,« Karl-Heinz Küfer emphasizes. Such a solution which cannot be improved in terms of all criteria simultaneously. When one criterion improves, another criterion has to worsen in compensation. In the case of radiation therapy this means that if the tumor is to receive a higher dose of radioactivity, the surrounding tissue will be damaged more severely.

The software was developed under the leadership of the ITWM together with the German Cancer Research Center, Heidelberg University Hospital and Massachusetts General Hospital in a Harvard Medical School researchpartnership. »With the new planning system the tumor can be better brought under control, since we can irradiate the tumor with a higher dose. This means the probability of permanently eradicating the tumor is also higher, and at the same time we can protect normal tissue which we might not have been able to protect at all inthe past,« remarks Professor Thomas Bortfeld, who in 2011 put the multi-criterion optimization approach to clinical use at Massachusetts General Hospital in Boston for the first time, together with RaySearch Laboratories.

With additional licensing through world market leader Varian Medical Systems startingin 2016, the technology will in the future be available at over 20,000 therapy planning stations around the world.

Development of the interactive multi-criterion radiation therapy planning system earned the Fraunhofer researchers Karl-Heinz Küfer, Michael Bortz, Alexander Scherrer, Philipp Süss and Katrin Teichert and their research partners Thomas Bortfeld, Jürgen Debus, Wolfgang Schlegel and Christian Thieke the Stifterverband for German Science‘s 2016 award. The jury specifically recognized »the broad viability of the method in treating thewidespread illness of cancer as well as the relevance to international markets.

More information can be found from Fraunhofer website by following this link.

Presentation video by Fraunhofer: Tailor-Made Radiation Therapy / Copyright Fraunhofer

Device to release cancer cells for better analysis

A new device developed at the University of Michigan could provide a non-invasive way to monitor the progress of an advanced cancer treatment.

It can pick cancer cells out of a blood sample and let them go later, enabling further tests that can show whether the therapy is successfully ridding the patient of the most dangerous cancer cells.



Cells released into the bloodstream by tumors could be used to monitor cancer treatment, but they are very difficult to capture, accounting for roughly one in a billion cells, says Sunitha Nagrath, U-M assistant professor of chemical engineering.

Nagrath and her collaborators pioneered technologies for capturing these cells from blood samples. Their devices trapped the cells on chips made with graphene oxide, a single layer of carbon and oxygen atoms. But all analysis had to be done on the chip because the cells were firmly stuck.

"We could grow the cells on the chip or analyze them all together, but research has shown that cancer cells are not all the same," she said. "Hence, it is important to study cells individually, and our new device makes this possible."

The stem cell theory of cancer holds that relapses occur because chemotherapy and radiation therapy are not very effective at killing cancer stem cells, which can make up as much as 10 percent of a tumor. As a result, the cancer stem cells left behind are able to regrow the tumor or spread to other areas of the body.

New treatments in clinical trials attack the stem cells, but killing this smaller population does not immediately shrink the tumor. Doctors need a good way to monitor whether the cancer stem cells are on the decline. This may be possible through blood tests, but clinicians need to study captured cells individually, and that means removing them from the chip.

A press release can be found from University of Michigan website.

Opportunities for cancer diagnostics and treatment devices

It is believed that many patients suffering from cancer could be treated if the tumor can be detected at very early stage.


Number of newly diagnosed cancer patients in China

As per statistics, number of newly diagnosed cancer patients keeps growing in China, which escalates the demand of medical devices and in-vitro products such as early screening devices, diagnostic devices, bio-markers, imaging devices and radiology equipment. This also generates opportunities for medical examination centers as well as independent medical imaging centers.