Venclexta Approved for Leukemia
April 11, 2016 – The FDA approved AbbVie and Genentech’s Venclexta™ (venetoclax) for second-line treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, which is detected by an FDA approved test. Chronic lymphocytic leukemia (CLL) is characterized by the build-up of abnormal white blood cells in the bone marrow and blood. Each year in the United States, approximately 15,000 patients are diagnosed with CLL. At the time of the original diagnosis, about 10 percent of these patients have 17p deletion which is a chromosomal alteration. Thirty to 50 percent of patients with relapsed or refractory CLL have 17p deletion. Patients with CLL with 17p deletion have an average life expectancy of less than three years.
Venclexta is also indicated for use in combination with Rituxan® (rituximab – Genentech / Biogen) with a breakthrough therapy designation for the treatment of relapsed or refractory CLL and for the first-line treatment of acute myeloid leukemia (AML) with hypomethylating agents in patients who are not candidates to receive standard high-dose chemotherapy.
FDA approval is based on a clinical trial that showed that 80 percent of patients treated with Venclexta had a complete or partial response to therapy. The suggested starting dose is 20mg once daily for seven days and should be titrated weekly to the recommended dose of 400mg once daily. Venclexta is available in 10mg, 50mg, and 100mg tablets. Venclexta is the first B-cell lymphoma 2 (BCL-2) inhibitor to gain FDA approval.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-332-0178
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