Melanoma is considered as a type of cancer that develops in the pigment-producing melanocyte cells. Anyway, tumors will grow in melanocytes of the skin in almost 90% of cases; it can also occur in melanocytes of the eye, internal organs, and mucosal membranes lining the gastrointestinal, respiratory and urogenital tracts. Changing patterns of sun exposure including habit’s toward going to vacation in sunny destinations and indoor tan will lead to this dramatic increase.
Therefore, drug development within melanoma has focused on cutaneous melanoma therapeutics. Although all melanoma therapeutics approved is indicated for the treatment of this patient subset. Further, as early-stage melanoma is highly treatable with surgery, the therapeutics are reserved for patients usually in the later stages of the disease.
It is considered one of the most challenging diseases to treat with pharmacotherapy; melanoma drug development lagged than many other cancers, going on in decades with limited progress.
In recent years, developments in molecular biology, have led to an increased understanding of the molecular heterogeneity of melanoma that has resulted in introducing new insights into the role of oncogenes, immune checkpoints, signaling pathways, and tumor-promoting studies, which will accelerate the discovery rate of therapeutic targets.
This will lead to the introduction of novel drugs that will transform this previous stagnant market and will improve treatment options for patients. Mainly, treatment strategies for specific patient subsets have shifted towards more-targeted treatments. Evidence from late-stage melanoma pipeline indicates that this trend is going to continue.
Research and development have gained a lot of attention in the past few decades of malignant melanoma therapeutics due to rapidly increasing incident cases. More numbers of clinical trials have been investigated to find an effective therapeutics with high safety and efficacy levels. The melanoma market was found to be dominated by chemotherapy and interferon therapy having poor benefit-to-risk ratios.
However, the market has been transformed by some breakthrough drug approvals in recent years, among which the approvals that marked the beginning are Yervoy (ipilimumab) and Zelboraf (vemurafenib). Yervoy and Zelboraf have become rapidly established as the first-line therapies in BRAF-negative and BRAF-positive advanced cutaneous melanoma, respectively by demonstrating unique survival benefits over the previously marketed therapies.
Some more recent drug approvals like the targeted therapies Tafin that was also approved for BRAF-positive melanoma, and immune checkpoint inhibitors Keytruda (pembrolizumab) and Opdivo (nivolumab). Amplimexon of Amplimed is phase 2 stage of development. Aside from Onxeo is in phase 1 clinical trials. Other products like Trilexium of Kazia is preclinically developed now.
Cancerous cells have been found to develop changes that will evade the effect of therapeutics leading to fewer efficacies.
These facts have to be overcome shortly and the investigators are trying to improve different modalities. Their prime concern is safety and efficacy because investigators are trying still to understand the exact mechanism of malignant melanoma behind factors leading to their development.
The long-term effect of this innovative therapeutics is under investigation, to apply for marketing approval in different countries.
Due to rapidly developing clinical pipelines, more innovative malignant melanoma therapeutics are going to enter into the global market in a few years leading to an increase in the market size. Furthermore, the commercial success of this novel products has seemed to be optimistic, but their commercialization will take some years.
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