FDA Approves Collaboration Drug After Extensive Clinical Trial Testing
Recently, pharmaceutical research companies AbbVie and Genentech cleared the clinical trial requirements set by the FDA to approve of their new drug to fight against chronic lymphocytic leukemia. The result of these two companies’ collaboration was the production of a newly approved drug, Venclexta. This approval makes Venclexta the first FDA-approved drug in a new class that combats BCL-2, a protein responsible for rapid cancer cell growth. By blocking the cancer cell boosted growth, the pill allows for the cell to age and die naturally.
About Chronic Lymphocytic Leukemia
Chronic lymphocytic leukemia is a subset of leukemia with a genetic abnormality making the leukemia more difficult to treat. Earlier this month, the FDA approved a new drug for those afflicted with chronic lymphocytic leukemia, specifically patients with a missing part of chromosome 17 who relapsed or who did not see improvement from an earlier treatment. This drug was the work of a collaboration effort from drug companies AbbVie and Genentech, with the pill labeled Venclexta.
Because chronic lymphocytic leukemia is incurable, relapsed patients must seek out a different drug after the prior one has failed. It is one of the most common type of leukemia found in adults, with about 15,000 newly reported annual cases in the U.S. alone.
Why The Venclexta Cancer Drug Works
Venclexta targets the “17p deletion” genetic abnormality. Patients who have relapsed or who have not seen improvement from previous treatments are more likely to have the abnormality, while those who have not undergone treatment at all make up to 10 percent of the chronic lymphocytic leukemia population. Those with the 17p deletion abnormality have a life expectancy of 3 years or less, so this treatment offers an additional hope especially for those who have relapsed/not benefited from prior treatments.
In the clinical research trial, 106 chronic lymphocytic leukemia patients with the 17p deletion were tested. Following the trial, about 80% had their leukemia cancer gone into full or at least partial remission – those partial remission patients are still being monitored for any changes. The changes have benefited the patients ranging from a 3 month to a 19 month range.
AbbVie hopes that the FDA will approve Venclexta for different patient populations as well. It has been given further breakthrough designations in two more uses, therefore covering patients beyond those with the 17p deletion, but for patients with differing blood cancers as well. The other current breakthrough designations for Venclexta include one for acute myeloid leukemia for newly diagnosed patients unable to undergo chemotherapy, and another for relapsed chronic lymphocytic leukemia – without the 17p deletion, to be used alongside Rituxan (Roche’s blood cancer drug).
The FDA approval of AbbVie/Genentech’s new leukemia drug is a huge step moving forward in the fight against cancer, as this drug will hopefully extend thousands, and even millions of lives for patients suffering from cancers like chronic lymphocytic leukemia. With that said, the reason for this step of progress was due to the countless hours of clinical testing used to show beyond a shadow of a doubt that this treatment can help people with this disease with little to no negative impact. As long as scientists continue to develop new ways to target these conditions, and people continue to sign up with patient recruitment clinical trials like these, we can continue to make strides towards ending cancer.