New drug against skin cancer

USA: New drug approved for skin cancer

09/06/2014

In the US, a new anticancer drug was approved. According to one study, it may appear to be effective in advanced melanoma disease. The response rate was around 25 percent.

Medicines are said to be effective in advanced melanoma disease
In the US, a new drug has been approved for the treatment of skin cancer. As the Austrian news agency APA reported, the US Food and Drug Administration has approved the first drug with the monoclonal antibody pembrolizumab that over the blockade of the PD-1 receptor (Programmed Death-1) can obviously act in advanced melanoma disease. The approval was therefore granted in an accelerated procedure on the basis of two studies involving 173 and 411 participants, respectively „Pharmaceutical newspaper“ reported. In 24 percent of "treated patients, the drug caused the tumor to shrink".

Therapeutics are being tested on several cancers
Currently, anti-PD-1 therapeutics - including pembrolizumab (Merck, Sharp & Dohme - MSD) - developed by several pharmaceutical companies and tested in several cancers. What until recently as „targeted cancer therapy“ has been designated, now trades in these drugs as „immunotherapy“, because they are supposed to stimulate the body's own defense reaction to the malignant cells. In the US registration trials, the new drug was clinically tested in patients with inoperable, metastatic, and progressive melanoma disease. It was a "very early phase 1b study that also clarifies the dosage". 24 percent of the patients responded to the treatment, with the effect lasting between 1.4 and 8.5 months.

Viennese oncologists presented the mode of action of immunotherapies
In June of this year, Viennese oncologists also presented studies on the mode of action of these immunotherapies at the annual meeting of the American Society of Oncologists (ASCO) in Chicago. Thus, they could be effective in both brain metastases as a result of carcinomas and in primary brain tumors (glioblastomas). For example, the Wiener oncologist Anna Sophie Berghoff showed together with scientists at the University Hospital Heidelberg in that the surface molecules of PD-1 and PDL-1 are present on cells of brain tumors. This also suggests the use of therapeutics based on the blockade of these structures of malignant cells.

Application for authorization filed in Europe
For the time being, the new drug was only approved in the US for patients who have already received all other existing therapies. These include two other drugs of targeted cancer therapy (vemurafenib and ipilipumab), which have different modes of action. The pembrolizumab manufacturer also submitted the application for approval in Europe in July this year. Pembrolizumab can also cause strong unwanted immune reactions, since not only malignant cells use the mechanism of action. Then the therapy should possibly be paused or discontinued, the company said. In previous studies, the most common side effects were fatigue (tiredness), cough, nausea, pruritus, rash, loss of appetite, constipation, body aches and diarrhea. (Ad)