Moderna’s experimental vaccine against skin cancer received the designation of an innovative therapy from the Food and Drug Administration (FDA), equivalent to Anvisa in the United States, according to the company’s statement on Wednesday (2/22).
The classification is given by the FDA when experimental drugs intended for the treatment of serious diseases are significantly more effective than existing ones. It allows data review and late-stage testing to be accelerated.
Moderna’s vaccine uses mRNA technology – the same used in the US company’s Covid-19 vaccine – in combination with Merck’s Keytruda drug, and is intended for the treatment of high-risk patients.
Keytruda works against the patients’ tumor cells. Moderna’s vaccine hands the keys to the tumor’s DNA signature to the immune system. With this strategy, the T cells are expected to work to fight you if the cancer returns.
Skin cancer is the most incident type of cancer in the country, according to the National Cancer Institute (Inca). The disease can appear anywhere on the body and, when identified early, has a good chance of being cured.Peter Dazeley/Getty Images
*****Photo-woman-peeling.jpgExaggerated and unprotected sun exposure throughout life, in addition to episodes of sunburn, is the main risk factor for skin cancer. According to Inca, there are several types of the disease, which are generally classified as melanoma and non-melanoma Barcin/Getty Images
****Photo-doctor-investigating-paint-suspicion-1.jpgNon-melanoma cases are more frequent and have high cure rates. In addition, this is the most common type in people over 40 and with fair skin.BSIP/UIG/Getty Images
****Photo-skin-cancer-3.jpgMelanoma, in turn, has fewer registered cases and is more serious, due to the possibility of spreading to other parts of the body. That’s why it’s important to make periodic visits to the dermatologist and ask about suspicious signs.JUAN GAERTNER/SCIENCE PHOTO LIBRARY/Getty Images
****Photo-skin-cancer-2.jpgDespite being a health problem that can affect anyone, there are profiles that are more prone to developing skin cancer, such as: having light skin, hair and eyes, family history of the disease, having multiple moles on the body, being an immunosuppressed and/or transplanted patientJodiJacobson/Getty Images
****Photo-doctor-investigating-paint-suspicion-2.jpgAccording to experts, it is important to investigate whenever a mole or mole has asymmetry, a rough or irregular edge, two or more colors, has a diameter greater than six millimeters, or changes in size over time. All of these signs can indicate the presence of a melanoma.kali9/Getty Images
****Photo-doctor-investigating-paint-suspicion-3.jpgThe first signs of non-melanone tend to look like a discolored lump, spot or sore that does not heal and continues to grow. In addition, it may still look smooth and shiny and/or look like a wart.Peter Dazeley/Getty Images
****Photo-doctor-investigating-paint-suspicion-5.jpgThe mole can cause itching, scabs, erosions, or bleeding over weeks or even years. In most cases, this cancer is red and firm and can develop into an ulcer. Marks look like scars and tend to be flat and scalyGetty Images
****Photo-skin-cancer-5.jpgSkin cancer usually appears in parts of the body where there is greater exposure to the sun, and is very much associated with inadequate protection with sunscreens.Callista Images/Getty Images
****Photo-doctor-investigating-paint-suspicion-4.jpgAccording to the National Cancer Institute, non-melanone tends to be completely cured when detected early. It rarely spreads to other parts of the body, but if not identified in time, it can spread to deeper layers of the skin, making it difficult to treat.SCIENCE PHOTO LIBRARY/Getty Images
****Photo-skin-cancer-6.jpgThe diagnosis of skin cancer is made by the dermatologist through clinical examination. In certain situations, it may be necessary to carry out the exam known as “Dermoscopy”, which consists of using a device that allows you to visualize layers of the skin not seen with the naked eye. In more specific situations it is necessary to perform a biopsyNoctiluxx/Getty Images
****Photo-surgery-for-skin-cancer-removal.jpgAccording to the Ministry of Health, “oncological surgery is the most suitable treatment to treat skin cancer for the removal of the lesion, which, in the early stages, can be performed without hospitalization”lissart/Getty Images
****Skin-cancer-illustration-1.jpgStill according to the folder, “in the most advanced cases, however, the treatment will vary according to the condition in which the tumor is found, and radiotherapy and chemotherapy may be indicated, in addition to surgery”ALFRED PASIEKA/SCIENCE PHOTO LIBRARY/Getty Images
****Picture-woman-putting-sunscreen-on-man.jpgAmong the recommendations for the prevention of skin cancer are: avoiding exposure to the sun, using sunglasses with UV protection, as well as umbrellas, umbrellas, wide-brimmed hats and clothes that protect the body. In addition, of course, to the daily use of sunscreen with a sun protection factor (SPF) of 15 or more.frankreporter/Getty Images
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The results of an interim Phase 2 study by the drugmaker, released in December 2022, showed that the therapy reduced the risk of disease recurrence after surgery by 44% compared to using Keytruda alone.
The two companies informed, through an announcementwho will continue to discuss the results with regulatory authorities and will start a phase 3 study later in 2023. They hope to expand the studies to other tumor types, including non-small cell lung cancer.
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