Leukemia Drug 'Venetoclax' From Roche, AbbVie Gets FDA Priority Review

The leukemia drug Venetoclax has been granted "priority review" status by the U.S. Food and Drug Administration (FDA). It is manufactured by Roche in collaboration with AbbVie.

Roche announced via a press release that the New Drug Application (NDA) for venetoclax has been granted priority review (PR) for treatment of people with leukemia. Venetoclax is a drug developed by the company in partnership with AbbVie and is intended for patients with chronic lymphocytic leukemia (CLL) who have received prior treatment.

"Venetoclax is a potential new way to treat this difficult type of chronic lymphocytic leukaemia," Dr. Sandra Horning, chief medical officer and head of Roche's Global Product Development, said. "We look forward to working with AbbVie and health authorities to bring this first-of-its-kind medicine to people who need more options."

The PR status was based on the drug's Phase II trials where it helped curb the growth of CLL cancer cells. According to Fierce Biotech, the drug was named ABT-199 before it was called Venetoclax and its purpose was to block B-cell lymphoma-2, a substance that increases the longevity of cancer cells in the blood.

"The drug's first target is patients who have CLL with a 17p deletion, a tough-to-treat variant that accounts for up to 10% of all CLL cases and as many as half of all relapsed or refractory instances of the cancer," said AbbVie, as noted by the website.

Reuters reported that the drug is expected to have FDA approval by early 2016. It has been predicted that it could sell $2 billion in annual sales by 2020. The drug will be marketed in the United States by Roche and by AbbVie in Europe.

Chronic lymphocytic leukemia is a type of blood cancer that starts in the bone marrow's white blood cells, according to the American Cancer Society. It starts slowly and, while the cancerous cells develop, many patients do not experience the symptoms. The cancer can spread to the liver, spleen and lymph nodes.

The results of the Phase II study were shared at 57th American Society of Hematology (ASH) Annual Meeting, according to Business Wire. The most common side effects of the drug were low blood cell count, low red blood cell count, low platelet count.

Serious side effects include low red blood cell count due to immune response, fever, low white blood cell count with fever, and pneumonia. The study reported cases of tumor lysis syndrome in five patients and higher infection in 20 percent of the patients.