The US Food and Drug Administration (FDA) has approved the first new generation immunotherapy drug for the treatment of advanced melanoma, the agency said on its website.
The drug pembrolizumab from the American company MSD is introduced to the market at an accelerated pace. A few weeks ago, the Agency was expected to decide on its registration at the end of October 2014. The registration of the drug is also expected soon in the European Union. Since July 2014, it has been evaluated by the European Medicines Agency (EMA).
Pembrolizumab is not the first drug in immunotherapy, for several years various preparations affecting the immune system have already been used in oncology. Some of them stimulate the patient’s immune system to be able to fight cancer cells on its own. Others, in turn, unlock the immune system. This is how the medicine used to treat advanced melanoma works. It works by blocking the CTLA-4 receptor on the surface of T lymphocytes, which in turn removes the blockage from them and activates them. They begin to destroy cancer cells.
Drugs that work in this way are already registered and used. The application for approval of the next applies to those that unlock the immune system in yet another way – by the so-called. PD-1 receptor. This is how pembrolizumab, a humanized monoclonal antibody, works, the first of its kind in immunotherapy. It has been tested in over 170 clinical trials, including in Poland.
Many cancers avoid attacking the patient’s immune cells because they inhibit the action of the PD-1 receptor. It is an immunoregulatory receptor located on the surface of active T lymphocytes (CD4 + and CD8 +) and B lymphocytes. When bound to its ligands PD-L1 or PD-L2, it disrupts the signaling pathway, which inhibits the activation of T lymphocytes. Cancer can then develop freely. New drugs have been designed to prevent this from happening.
Head of the Warsaw oncology clinic at ul. Wawelska belonging to the Oncology Center in Warsaw, prof. Piotr Wysocki explains that the new immunotherapy preparations act on PD-1 receptors, thanks to which they restore the immune system’s ability to recognize and act on cancer cells.
The specialist claims that this kind of anti-cancer-directed activation of the immune system is the most prolonged life of melanoma patients, but it also gives good results in patients with advanced non-small cell lung cancer. This therapy is also being tested in the treatment of around 30 other cancers.
There are great hopes associated with immunotherapy in the treatment of patients with metastases, i.e. generalized disease. Until now, they could only slightly extend their lives. Prof. Wysocki claims that for the first time there was hope that it will now be possible to achieve higher survival rates.
Soon, registration of other similarly-acting preparations is expected, with high hopes for more effective treatment of various advanced malignant neoplasms, not only melanoma. Drugs from companies such as Bristol-Myers Squibb, Roche and AstraZeneca are in the final stage of research. One of them is to be registered next year for the treatment of lung cancer. Another drug will be used for bladder cancer.
In the coming years, immunotherapy may even dominate the treatment of advanced malignant neoplasms, provided that their effectiveness is confirmed. According to Reuters, by 2025 the value of annual sales of preparations acting on the PD-1 receptor may exceed USD 30 billion. (PAP)