AbbVie, Genentech Partnership Could Get FDA Approval for New Leukemia Drug

Leukemia DrugCancer has long been one of the most important medical topics but only in the last few years have we seen the medical industry achieve large advances in research, development, and technology in terms of treating this disease. Of course, cancer is tough to treat because while we understand its characteristics, its behavior can be unpredictable and it is not always easy to diagnose; even then, it is even more difficult to treat.

These days, we are beginning to understand cancer at not only the cellular level but at a genetic level as well. Still, our new understanding has not yet yielded new treatment methodologies and we will continue to treat cancer with drugs; at least, for the time being.

But while we continue to work towards better identification and diagnosis methods and better ways to stop its typical behaviors, medical science has made large advancements in the understanding of specific cancers, for example: leukemia. And this has led to better drugs.

In regards to leukemia drugs, then, the United States Food and Drug Administration has approved the new drug Venetoclax, a joint effort from AbbVie and Genentech. The FDA has granted priority review status to the drug for use in adults who have chronic lymphocytic leukemia and have had at least one previous form of therapy.

According to Genentech chief medical officer and chief of Global Product Development, Sandra Horning, MD, “Venetoclax is a potential new way to treat this difficult type of chronic lymphocytic leukemia. We look forward to working with AbbVie and health authorities to bring this first-of-its-kind medicine to people who need more options.”

In the clinical trial for this drug, patients received venetoclax once a day with a once-a-week increase on a schedule of 50, 100, 200, 400 mg over a 5-week period.

The researchers found that nearly 80 percent of the 107 patients evaluated showed a positive response to the drug in accordance with evaluation from an independent review committee. This includes 7.5 percent of patients who showed a complete response or a complete response with incomplete marrow recovery.

Roche Holding AG, who will retain the venetoclax marketing rights in the United States, anticipates full FDA approval for the drug in the first half of 2016.

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