FDA: The world first “cancer vaccine” has made a breakthrough
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FDA: The world first “cancer vaccine” has made a breakthrough
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FDA: The world first “cancer vaccine” has made a breakthrough and is expected to be approved soon!
Heavy news in the medical world: the world’s first “cancer vaccine” may be coming soon!
On Feb. 22, Moderna announced its experimental personalized mRNA skin cancer vaccine, in combination with Merck & Co’s (MRK.N ) drug Keytruda, had received approval from the U.S. Food and Drug Administration (FDA) . Breakthrough Therapy designation as an additional treatment for high-risk patients.
This treatment is called KEYNOTE-942/mRNA-4157-P201.
Breakthrough Therapy designation is granted by the FDA to expedite the development and review of drugs intended to treat serious diseases.
The FDA’s decision is supported by phase 2b clinical trial data, which means it could be approved within a few months!
The Phase 2 clinical trial in the middle stage is conducted on approximately 150 patients who have undergone surgery for stage 3 and 4 malignant melanoma with advanced cancer.
Experiments have proved that a personalized skin cancer vaccine made with mRNA technology for the first time can effectively reduce the chance of death or cancer recurrence in melanoma patients .
The study showed the treatment reduced the risk of skin cancer recurrence or death by 44% compared with Keytruda alone .
This is another milestone in the history of human medicine!
Because of the COVID-19 epidemic, “mRNA”, a high-tech term known only to professionals, has become catchy to the general public in the past three years, and half of them can tell its technology.
The medical field has also applied “mRNA” technology to various diseases. The development of cancer therapeutic drugs using the “mRNA” technology that has been practically used in the new coronavirus vaccine is becoming more and more active.
The new vaccine uses messenger RNA technology, in which DNA is extracted from each patient’s tumor. This genetic segment is then inserted into messenger RNA, the molecule that carries the cells’ instructions for making proteins.
Once inside the body, the messenger RNA delivers this code to human cells, teaching them to recognize cancer cells and attack them when they return, thereby inhibiting recurrence.
The vaccine is given to patients after surgery to prevent tumor recurrence and is tailored to each patient, meaning no two shots are the same.
The FDA upgraded its approval status yesterday, potentially reducing the approval time to six months instead of the regular 10 months.
Moderna is also fast-tracking its plans to start phase 3 trials of its skin cancer vaccine in 2023, as well as other cancer vaccines, which could then be tested on thousands of patients. Merck also plans to team up with Moderna to produce and distribute the vaccine.
As for the price of this vaccine after it comes out ?
The cost of creating a cancer vaccine is high, the researchers say . “This personal vaccine takes about one to three months. And it’s expensive, maybe $100,000 for each patient, to make a vaccine that’s right for him, because everyone’s tumor is different. There are different mutations.”
At the same time, BioNTech will also conduct relevant clinical trials . In addition to mRNA drugs, BioNTech will advance about 20 clinical trials in the field of cancer.
In January, BioNTech entered into an agreement with the UK government to develop mRNA drugs for cancer treatment. The proposed goal is to provide up to 10,000 patients with cancer treatment drugs by the end of 2030.
In addition, Germany’s CureVac is also advancing early-stage clinical trials targeting metastatic melanoma in combination with cancer immunotherapy.
According to the forecast of British Appraisal Co., Ltd., the market of pharmaceuticals using mRNA technology will grow from 354 million US dollars in 2020 to 17.8 billion US dollars in 2028 .
However, since this is a new technology, much remains unknown about its effectiveness and safety.
Still looking forward to the day when more cancer vaccines come out!
FDA: The world first “cancer vaccine” has made a breakthrough and is expected to be approved soon!
(source:internet, reference only)
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