FDA approves new treatment for resustressable multiple myeloma

Recently, the U.S. Food and Drug Administration approved Xpovio (selinexor) tablets in combination with corticosteroid dexamison for the treatment of adult patients with recurring refractic multiple myeloma (RRMM), who have been treated at least four times and whose disease is resistant to several other forms of treatment, including at least two protease inhibitors, immunomodulants, and anti-CD38 monoclonal antibodies.
“ Although multiple myeloma is incurable, FDA-approved treatments can target cancer and slow the spread of the disease. Sadly, often over time, patients can exhaust all available treatments and still see their disease progress," said Richard Pazdur, FDA's Ph.D., director of oncology and acting director of the FDA's Office of Hematology and Oncology Products at the FDA Center for Drug Evaluation and Research. "
multiple myeloma is a cancer that starts with plasma cells (white blood cells that produce antibodies), also known as plasma cell myeloma. Abnormal plasma cells accumulate in the bone marrow, forming tumors in many bones of the body. As more antibodies are produced, it can thicken the blood and prevent the bone marrow from producing enough healthy blood cells. The exact cause of multiple myeloma is not known, but it is more common in older adults and African-Americans.
We evaluated the efficacy of 83 RRMM patients treated with Xpovio's combined symisson. At the end of the study, the overall response rate was measured at 25.3%. The medium time for the first reaction is four weeks, ranging from one to ten weeks. The average reaction duration was 3.8 months. The efficacy assessment is supported by additional information from ongoing randomized trials in patients with multiple myeloma.
Common side effects in patients treated with a combined treatment of Xpovio and dexemism include low white blood cell count (white blood cell reduction), low neutral granulocyte count, white blood cell type (neutral granulocyte reduction), low plate plate count (reduced plate plate) and low red blood cell count (anemia). The report also showed vomiting, nausea, fatigue, diarrhea, fever, loss of appetite and weight, constipation, upper respiratory tract infections, and low blood sodium levels (hyponamicemia).
Health care professionals are recommended to monitor patients' blood cell counts, plateplates, and sodium levels. Patients should avoid Xpovio and other medications that may cause dizziness or confusion, and avoid situations in which dizziness can become a problem. Health care providers are advised to optimize the patient's hydration status, blood cell count, and other medications to avoid dizziness or confusion. The U.S. Food and Drug Administration recommends that health care professionals inform women of childbearing age and male and female partners with reproductive potential to use effective contraception during Xpovio treatment. Pregnant or lactating women should not take Xpovio because it can cause harm to a developing fetus or newborn. Xpovio must waive the patient medication guidelines, which describe important information about the use and risks of the drug.
Xpovio's accelerated approval in a joint with Desemisson allows the FDA to approve drugs for serious illnesses to meet unsettly medical needs based on endpoints that may predict a patient's clinical benefits. Further clinical trials are needed to validate and describe the clinical benefits of Xpovio.
The FDA approved the fast-track designation of the application. Xpovio has also been awarded the title of Orphan Drug, which provides incentives to assist and encourage the development of drugs for rare diseases. The FDA granted approval for Karyopharm Therapeutics' Xpovio drug. (Compiled by this web)