Venclexta Receives Full Approval
June 8, 2018 – The U.S. FDA has granted regular approval for Venclexta® (venetoclax), manufactured by AbbVie and Genentech. The product is indicated for use in combination with Genentech’s Rituxan® (rituximab) for the treatment of patients who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, and who have received at least one prior therapy.
Granted accelerated approval in 2016, Venclexta is a BCL-2 inhibitor and targets a specific protein in the body that prevents cancer cells from dying. Full approval was based on a clinical study in which treatment with Venclexta and Rituxan reduced the risk of disease progression or death by 81% compared to a current standard of care that uses bendamustine in combination with Rituxan. The overall response rate of patients treated with Venclexta and Rituxan was 92%, versus 72% with bendamustine and Rituxan.
Recommended dosing with Venclexta is 20mg once daily for the first seven days. Dosage should then be increased to 50mg once daily in the second week, 100mg in Week 3, 200mg in Week 4, and 400mg in Week 5. Treatment with Rituxan can begin during the sixth week. Venclexta should be taken with a meal and water.
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 U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.