Swiss pharmaceutical company Roche has recently announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for venetoclax used for chronic lymphocytic leukemia (CLL) treatment.
Roche reveals that venetoclax is an investigational drug under development in association with research-based biopharmaceutical company AbbVie. The medicine will be used on patients who have refractory or relapsed CLL through 17p deletion a genetic abnormality.
The pharmaceutical company explains that patients who have refractory or relapsed CLL with 17p deletion usually have poor prognosis. Current treatment options do not work well on these patients.
"We are pleased that the FDA has granted venetoclax Breakthrough Therapy designation and hope this regulatory pathway will help us bring venetoclax to people with this difficult-to-treat disease soon," says Sandra Horning, Chief Medical Officer of Roche.
The breakthrough therapy designation is designed for accelerating the review and development of medicines that are intended for treating life-threatening and serious diseases with evidences reflecting that the drugs may offer a considerable improvement over existing treatment options.
CLL is a type of cancer that progresses slowly which affects the bone marrow and blood. CLL starts in the lymphocytes, or white blood cells, in the bone marrow. Leukemia cells then start building up in the patient's body. Many patients do not show any symptoms of the disease for the initial few years.
Medical experts suggest that there are two types of CLL. The first one is a very slow progressing and rarely requires any treatment. People suffering with this type of CLL can survive for 15 years or even more.
The second type of CLL grows relatively faster and considered serious. Patients with this type of CLL can survive for about eight years.
Scientists suggest that normally leukemia cells of both the CLL types are similar; however, new tests suggest that cells for individual type of CLL are distinctive.
CLL normally affects older people. More than 75 percent of the patients diagnosed with CLL are 50 years or over and a major chunk are males. However, teenagers and children may also get the disease in rare circumstances.
It may be years before venetoclax is commercially available; however, it may help doctors save the lives of many people suffering with CLL.
