The FDA Food and Drug Administration (FDA) has reported on the accelerated approval of a new cancer drug. We are talking about the product selinexor, which is produced under the trade name Xpovio. It is intended for the treatment of multiple myeloma. The sickness is also known as The myeloma disease. This is the disease of the blood. In this case, the malignant tumor of plasma cells is localized mainly in the bone marrow (recall that it is responsible for the production of new blood cells).
The authors develop from the Oncology Center Abramson at the University of Pennsylvania explained that according to the principle of selinexor differs from other anticancer drugs. It is a selective inhibitor of nuclear exports: penetrates the cell and affects the mechanisms that are responsible for the transportation of certain molecules inside cells and out of it. The fact is that cancer cells need to export from the nucleus protein called XPO1. The latter suppresses tumor growth, blocking this process will facilitate the destruction of cancer. This is the task of the new drug. It is reported that the recently concluded the second phase of clinical trials selinexor involving 83 patients who have not helped other cancer drug.
The volunteers received 80 milligrams of selinexor and 20 milligrams of dexamethasone in the form of tablets two times a week. The Medication proved effective in more than 25% of cases. The tests also showed that the selinexor works independently of the previous treatment. Its effectiveness depends on how aggressive cancer and how high genetic risk of development of oncology. Nevertheless, the essential condition with which the FDA approves further testing of the drug is that it should be appointed only if four or more existing schemes of treatment of multiple myeloma have been unsuccessful.
This limitation is due to the fact that the application of the selinexor involves certain risks.
The drug may influence not only on cancer but also on the healthy cells – violate their ability to transport proteins of the inward and outward. This can lead to complications, such as a decrease in the number of platelets, red blood cells or leucocytes. Thus, in the second phase of clinical trials of at least 20% of the patients side effects included thrombocytopenia, anemia and leukopenia (reducing the number of platelets, erythrocytes and leukocytes, respectively), as well as fatigue, nausea, loss of appetite and weight, diarrhea, vomiting, shortness of breath, and infections of the upper respiratory tract.
The experts, conducting clinical trials, believe that the condition of the FDA justified and made in accordance with the risks. Selinexor indeed will be the drug of the “last hope”, that is, the means which can be used only as a last resort – at the stage of treatment when the safer options do not work. The second phase of clinical trials for the drug details described in the article, presented in the Journal of Clinical Oncology. Currently, selinexor passes third phase clinical trials. At this stage, the experts want to test how effective and safe is a combination of the drug in a lower dosage with other cancer therapy.