Bristol-Myers Squibb announced this week that the U.S. Food and Drug Administration (FDA) has approved Yervoy (generic name ipilimumab) at a recommended dosage of 10 mg/kg for the treatment of patients with melanoma. The drug will help battle the cancer that has spread to regional lymph nodes of more than one mm. It’s primarily for patients who have undergone complete surgical removal of the skin cancer, including total lymphadenectomy, or removal of affected lymph nodes. Stage III is diagnosed because of involved of lymph nodes, which makes treatment a bit more complicated, because lymph nodes communicate with other lymph nodes, which can quickly causes a spreading, also called “metastatisis” of the original cancer to places elsewhere in the body, and that is usually what leads to a cancer being classified as terminal or fatal.
Surgically treatable, stage III melanoma makes up about 5 percent, or around 3,100 cases, of all new melanoma cases diagnosed annually in the United States. This stage of melanoma tends to be very aggressive, with a 60 percent risk of recurrence after surgery, meaning that despite wide-resection surgeries, it continues to come back. Because of the fact that the risk of disease returning among stage III melanoma patients following surgery, there is a need for other treatment options, which has been quite limited until Yervoy was made available to help reduce the risk of recurrence after surgery.
Clinical trials were very promising, but that is just the first stage of seeing how a medicine really works — the main challenge during clinical trials is to make sure it’s safe for the human body and appears to do some type of good against the disease. Detailed data on a drug usually isn’t possible until years after it has been in use and prescribed by physicians. Michael Giordano, M.D., senior vice president, head of Development, Oncology, Bristol-Myers Squibb, discussed how he feels Bristol-Myers Squibb is leading the fight, according to Yahoo!.
“The science of Immuno-Oncology is rapidly advancing, and we are proud to be the first to demonstrate the potential of an immune checkpoint inhibitor in the adjuvant setting, an earlier stage of the disease, where patients urgently need new medicines. The approval of Yervoy for the treatment of adjuvant melanoma underscores our scientific leadership in Immuno-Oncology, with a commitment to further developing our I-O agents – Yervoy and Opdivo – across multiple tumor types and at many stages of disease.”
This offers hope that more cancer-fighting drugs may be on the way, but that is not to say that they, or any cancer treatment drug, is not without risk. Sometimes the risks are very significant. Yervoy is associated with a boxed warning, a mandate of the FDA for all drugs to warn users about significant side effects, and can result in severe to fatal immunologic reactions, which is common of cancer-fighting medications. These immune-mediated reactions may harm any and all organs in the body, but the most common fatal reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis, in which massive portions of skin is killed), and neuropathy, which affects nerves and can adversely affect breathing, leading to a rarely known condition called Guillian Barre, a neuro-medical diagnosis that can cause paralysis of the diaphragm, which leads to the inability of the lungs to work on their own. Sometimes this gets better, but usually needs treatment with a ventilator, or artificial breathing machine. Guillian Barre is also associated with vaccines, as previously reported by the Inquisitr, which you can read about here.
All medications carry risks, many significant, although serious reactions are rare. As with many drugs, these medications may be unsuitable for pregnant women because they are known to cause abnormalities in the unborn child during development. They are also considered unsafe for lactating women, because this medication may pass in breastmilk to the baby and causes complications, as reported by marketedwire.
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