According to Roche Holding Ltd. (ADR) (OTCQX:RHHBY), the Food and Drug Administration (FDA) has approved Venclexta (venetoclax), a drug that can restore the self-destrution capabilities of a cell, for patients suffering from chronic lymphocytic leukemia (CLL) with 17p deletion, a genetic marker that makes the condition more difficult to treat.
Study results showed that 80.20% of patients have experienced significantly improved overall response rate (ORR), leading to the drug’s accelerated approval.
Venclexta is expected to be available in the US by next week. Assistance programs will be offered to qualified CLL patients starting then.
What is Venclexta?
Being the first of its kind to receive a coveted approval from the FDA, Venclexta was designed to aid in restoring the self-destruction process of cells by blocking the BCL-2 protein.
According to Sandra Horning, M.D., Chief Medical Offcer and Global Product Development Head, nearly half of CLL patients suffer from 17p deletion. The development of Venclexta is meant to help treat the disease, giving hope to patients.
Roche, together with AbbVie, Inc. (NYSE:ABBV), has been developing the drug. It is locally commercialized in the US by Genentech, Inc. and internationally commercialized by AbbVie.
However, there are a few adverse side effects that come along with the drug. These include diarrhea, fever, low white blood cell (WBC) count and/or low red blood cell (RBC) count, low platelet count, nausea, tumorlysis syndrome (TLS), upper respiratory tract infection, and pneumonia.
FDA Accelerated Approval Program
The Accelerated Approval Programof the FDA is meant to conditionally approve a medication that sustains unmet needs for serious illnesses based on ORR. Continued approval for such medicine depends on confirmatory trial results.
The FDA has given Breaththrough Therapy Designation to Venclexta. The designation advances the development of new drugs that are capable of treating difficult-to-treat diseases. Moreover, it guarantees immediate access to patients who need the medication.
Furthermore, the FDA has given Venclexta’s new drug application a designation of Priority Review. This indicates that the medicine is capable of providing meaningful improvements among ill conditions.