FDA Approves Venclexta
This past April, the FDA approved a new drug, targeting treatment for a form of leukemia that has been especially difficult to treat due to a specific chromosomal abnormality. The drug is called Venclexta and treats Chronic Lymphocytic Leukemia.
Chronic Lymphocytic Leukemia
Chronic lymphocytic leukemia (CLL) begins in lymphocytes, which are found in bone marrow. The cancer grows in the bone marrow and the moves into the blood. Because the cells spread slowly, they can reach other areas of the body such as the liver, spleen, and lymph nodes before patients have any symptoms. There are two types of CLL. The first type grows slowly and patients may not need treatment for an extended period. The other kind grows more quickly and is considered more dangerous. The cells look similar, but lab tests can differentiate between the two by looking for the proteins CD38 and ZAP-70. Low amounts of these proteins indicate it is the slower growing form.
Venclexta is designed to treat a segment of patients who have what is known as 17p depletion. Patients with this chromosomal abnormality make up about 10 percent of CLL patients. It appears the abnormality is more common in patients who have not benefited from the standard treatment, and those who have relapsed. The drug was tested on 106 patients with the abnormality. Eighty percent of these patients had their cancer go into remission, prompting the FDA to hasten the review and approval process.
Treatment for the first year is expected to cost just over $100,000 for the first year, and slightly more for subsequent years. However, financial assistance is available and it should be possible for patients to reduce their copayment to as little as $25. Venclexta is still undergoing the approval process in Europe, and additional patient testing is expected.
The most common side effects reported by participants of the clinical study include diarrhea, decreased levels of blood-clotting platelets, respiratory infections, fatigue, and nausea. More serious side effects were also seen, including pyrexia, pneumonia, tumor lysis syndrome, anemia, febrile neutropenia, and autoimmune hemolytic anemia. Because of the limited number of participants, other side effects may emerge as the drug enters the marketplace.
The maker of Venclexta expects to have the product available to be prescribed to patients by May.