New mesothelioma treatments are anticipated to emerge from a new medically-advanced FDA oncology center. U.S. Vice President Joseph Biden announced plans for the new FDA Oncology Center of Excellence (OCE) as part of the administration’s ambitious new “Cancer Moonshot” initiative.
The $1 billion “Cancer Moonshot” initiative is a sweeping new program aimed at speeding development of new cancer treatments by eliminating red tape snags and facilitating better collaboration between cancer patients, scientists, industry, and government.
The new “Cancer Moonshot” initiative was initially announced by President Barack Obama as part of his State of the Union address in January.
A “moonshot” used to mean the risk-taking far-reaching scientific effort to launch a spaceship to the moon. Today it is used in a technology context to describe an ambitious, exploratory and ground-breaking project launch. This includes medical technology such as cancer treatments.
Mesothelioma is a lethal cancer developed by people who have been exposed to asbestos.
New mesothelioma treatments are much needed. The currently available mesothelioma treatments have been around for decades and offer few options – chemotherapy, radiation and in some cases surgery – with limited results.
Biden Lost Son To Cancer Last Year
Biden announced the new OCE at a cancer conference at Howard University in Washington D.C. He spoke with emotion about the need for a new urgency in the fight against cancer. Biden’s 46 year-old son Beau died last year from brain cancer. Biden admitted that coping with this devastating personal loss has fired his passion for this project.
“I believe we can do in the next five years what would normally take 10 years,” he said. “Time matters, days matter, minutes matter.”
New Mesothelioma Treatments Part of New Cancer Research Efforts
New mesothelioma treatments may not have seemed to have much in common with new treatments for brain cancer under the old ways of thinking about cancer. But new medical scientific approaches to treatment have adapted the position that all cancer processes may have enough in common to make treatments effective across various tumor types and tumor locations.
This new approach to cancer treatments, including new mesothelioma treatments, is expected to make it faster and more economically feasible to develop treatments for cancers that in the past lacked sufficient numbers of patients to bring new drugs to market. The existing FDA pathways to new drug research, including clinical trials, and drug approval is known to be very expensive and time consuming. This slow progress has been a source of despair to cancer patients – and to their broken-hearted families who lose loved ones knowing that a new treatment being developed may have helped.
As a key component of the new plan to try to eliminate inefficiency and logjams at the federal level, Biden announced the formation of the new OCE within the Food and Drug Administration, to coordinate and review all proposed new FDA cancer treatments.
New Mesothelioma Treatments May Not Fit Existing FDA Categories
The new OCE planned for FDA’s offices near Washington D.C. comes at a time when research advances are making it possible for cancer researchers to customize drugs to an individual’s genetic profile.
Under the existing FDA review system, biotech and pharmaceutical companies trying to get a new drug approved submit it to different divisions within the agency depending on whether the new cancer treatment is a drug, a device or a biologic, a drug made from living cells. A treatment that combines two or all of these currently would have to be reviewed several times.
The big new idea is that the OCE will coordinate all cancer treatments, including new mesothelioma treatments, under one center instead of different divisions.
New mesothelioma treatments are currently being developed that would use a mesothelioma patient’s own immune system and immune cells as part of the treatment. These new mesothelioma treatments may not fit neatly into one of the FDA’s existing categories and may benefit from this new more broad approach being suggested as part of the new OCE program.
“We are moving into a very complicated area in oncology where drugs and devices and biologics are going to be used in combination or sequentially,” Dr. Richard Pazdur, a current FDA cancer research administrator, said in an interview.
Dr. Pazdur, who has 20 years of experience in reviewing cancer drugs, has been appointed interim head of the new OCE and will oversee the establishment of the center and act as its director for the next 120 days.
Cancer patient advocacy groups and other cancer support organizations view the new OCE as a positive step in a process that they have viewed as too slow.
Ellen Sigal, chair of the advocacy group Friends of Cancer Research, which helped develop the new OCE concept, said during an interview, “This shows that the FDA and its leadership are committed to innovation, adapting to the changing scientific landscape and understands the need for the agency to better reflect how patients are being treated.”
Better Access to New Mesothelioma Clinical Trials
Biden outlined several other initiatives for the new “Cancer Moonshot” initiative. These include making it easier for cancer patients to find and participate in clinical trials. This would be achieved through the creation of a new cancer clinical trials website.
Participating in a mesothelioma clinical trial is a way for patients to try new mesothelioma treatments before they receive full FDA approval.
Biden also highlighted that the “Cancer Moonshot” wants to help scientists spend more of their time on research and less time on trying to raise money to fund their research.
“We have to change the culture that turns scientists into grant writers,” Biden said.