Karyopharm, a pharmaceutical company based in Newton, Massachusetts, has submitted a New Drug Application to the FDA for their drug XPOVIO, which is meant for the treatment of diffuse large B-cell lymphoma. They want accelerated approval of this drug, as they have already received the Orphan Drug designation and Fast Track designation. XPOVIO is Karyopharm’s first-in-class, oral treatment. They hope that this drug will improve the lives of those who have not responded to previous treatment and are ineligible for a stem cell transplant.
About Diffuse Large B-Cell Lymphoma
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma across the world. 18,000 people are diagnosed with this cancer every year. B-lymphocytes, which are a type of white blood cell, are affected in this disease. They make antibodies and are integral in fighting infections. While it tends to develop in the lymph nodes, it has the potential to affect any organ. It may also spread throughout the body and become generalized. People of any age can have this cancer, but the chance of this disease increases with age, and those over 60 are the most common patients.
One of the first symptoms of this cancer is a swelling of the lymph nodes, which can occur in the neck, groin, or armpits. If the cancer begins in other organs of the body, then swelling, pain, and discomfort will occur in those areas. Other general symptoms of this cancer are fevers, night sweats, and unintentional weight loss.
Treatment for diffuse large B-cell lymphoma needs to occur as soon as possible after diagnosis, as this cancer does progress quickly. Chemotherapy is the most common form of treatment, but radiation and stem cell transplants are other options. DLBCL has been shown to be responsive to treatment in the past, and a significant percentage of people have been cured.
XPOVIO is an oral Selective Inhibitor of Nuclear Export (SINE) compound. This treatment binds to and inhibits a protein called exportin 1. It then stops proteins that help to suppress tumor growth, reduce inflammation, and stop new tumors from leaving the nucleus. When these proteins accumulate in the nucleus of the cell, they lead to anti-cancer activity within the cell. This treatment is intended for those who have relapsed or refractory diffuse large B-cell lymphoma. Participants in the studies of this drug have already gone through two rounds of multi-agent therapies and are ineligible for stem cell transplants.
This drug did bring side effects, such as thrombocytopenia, neutropenia, gastrointestinal toxicities, nausea, vomiting, diarrhea, anorexia, weight loss, hyponatremia, infections, and neurological adverse effects. It is important that there is monitoring during this treatment in order to treat these adverse affects.
Results of the Study of XPOVIO
The SADAL study was conducted in 2019, and resulted in a 28.3% overall response rate. The complete response rate of this study was 11.8%. Of all the participants in the study, the median length of treatment was 9 months. These results have given hope to Karyopharm that their therapy will give a new treatment option to those who have limited choices. If XPOVIO does receive approval from the FDA, it will be the first and only oral treatment for those with refractory or relapsed diffuse large B-cell lymphoma.
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