Roche announced that the company submitted a New Drug Application for vemurafenib to the U.S. Food and Drug Administration (FDA)and a Marketing Authorization Application to the European Medicines Agency (EMA) for approval for people with BRAF V600 mutation-positive metastatic melanoma.The submissions are based on results from two positive clinical studies :-
both these evaluated vemurafenib in people with BRAF V600 mutation-positive metastatic melanoma. The test will also will also be registered in Europe.
About metastatic melanoma
Basically it is several malignant neoplasms (usually of the skin) consisting of melanocytes. Melanocytes are cells that produce the dark pigment, melanin, which is responsible for the color of skin. They predominantly occur in skin, but are also found in other parts of the body, including the bowel and the eye. Melanoma can occur in any part of the body that contains melanocytes.elanoma is less common than other skin cancers. However, it is much more dangerous and causes the majority (75%) of deaths related to skin cancer.he diagnosis is more frequent in women than in men and is particularly common among Caucasians living in sunny climates, with high rates of incidence in Australia, New Zealand, North America, and northern Europe.
Note:-According to a WHO report about 48,000 melanoma related deaths occur worldwide per year.
Main Cause of Melanoma :-All cancers are caused by damage to the DNA inside cells. This damage can be inherited in the form of genetic mutations, but in most cases it builds up over a person’s lifetime and is caused by factors in their environment. DNA damage causes the cell to grow out of control, leading to a tumor. Melanoma is usually caused by damage from UV light from the sun, but UV light from sunbeds can also contribute to the disease.
A gene, Serine/threonine-protein kinase B-Raf or simply B-R.B-Raf is a member of the Raf kinase family of serine/threonine-specific protein kinases. This protein plays a role in regulating the MAP kinase / ERKs signaling pathway, which affects cell division, differentiation, and secretion.The BRAF protein is a key component of the RAS-RAF pathway involved in normal cell growth and survival. Mutations that keep the BRAF protein in an active state may cause excessive signalling in the pathway, leading to uncontrolled cell growth. These mutations of the BRAF protein are thought to occur in an estimated half of all melanomas and eight percent of solid tumors.
It is an oral multi-kinase inhibitor developed by Roche which targets angiogenic, stromal and oncogenic receptor tyrosine kinase (RTK). It shows anti-angiogenic activity due to its dual targeted VEGFR2-TIE2 tyrosine kinase inhibition. It is currently being studied as a potential treatment option in multiple tumor type.