Venclexta (venetoclax)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.


Approval Status:

Approved April 2016

Specific Treatments:

chronic lymphocytic leukemia with 17p deletion

Therapeutic Areas

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General Information

Venclexta (venetoclax) is a BCL-2 inhibitor, an antiapoptotic protein.

Venclexta is specifically indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy.

Venclexta is supplied as tablets for oral administration. Initiate therapy with Venclexta at 20 mg once daily for 7 days, followed by a weekly ramp-up dosing schedule to the recommended daily dose of 400 mg. Venclexta tablets should be taken orally once daily with a meal and water. Do not chew, crush, or break tablets.

Clinical Results

FDA Approval

The FDA approval of Venclexta was based on an open-label, single-arm, multicenter clinical trial of 106 patients with CLL with 17p deletion who had received at least one prior therapy. Patients received Venclexta via a weekly ramp-up schedule starting at 20 mg and ramping to 50 mg, 100 mg, 200 mg and finally 400 mg once daily. Patients continued to receive 400 mg of Venclexta orally once daily until disease progression or unacceptable toxicity. The efficacy of Venclexta was evaluated by overall response rate (ORR) as assessed by an Independent Review Committee (IRC) using the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines. The ORR was 85%. The median time to first response was 0.8 months. Median duration of response (DOR) had not been reached with approximately 12 months median follow-up. The DOR ranged from 2.9 to 19.0+ months.

Side Effects

Adverse effects associated with the use of Venclexta may include, but are not limited to, the following:

  • neutropenia
  • diarrhea
  • nausea
  • anemia
  • upper respiratory tract infection
  • thrombocytopenia
  • fatigue

Mechanism of Action

Venclexta (venetoclax) is a selective and orally bioavailable small-molecule inhibitor of BCL-2, an antiapoptotic protein. Overexpression of BCL-2 has been demonstrated in CLL cells where it mediates tumor cell survival and has been associated with resistance to chemotherapeutics. Venetoclax helps restore the process of apoptosis by binding directly to the BCL-2 protein, displacing pro-apoptotic proteins like BIM, triggering mitochondrial outer membrane permeabilization and the activation of caspases.

Additional Information

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