FDA Approves Expanded Indication for Venetoclax

May 16, 2019

Venetoclax, a BCL-2 inhibitor first approved in 2016, is now indicated for chronic lymphocytic leukemia and small lymphocytic lymphoma.

The FDA has announced the approval of an expanded indication for venetoclax tablets (Venclexta, AbbVie Inc. and Genentech). Originally approved in 2016, the drug is now also indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 

The new approval is based upon the results of a CLL14 trial, specific data from which is expected to be available in the near future. According to a release, "the CLL14 trial demonstrated superior progression-free survival as assessed by an independent review committee... in patients treated with VENCLEXTA plus obinutuzumab compared to patients who received chlorambucil plus obinutuzumab."

"This FDA approval provides a new chemotherapy-free combination treatment option for patients, and underscores the growing utility of VENCLEXTA in CLL," said Michael Severino, MD, vice chairman and president of AbbVie.  "The approval is based on findings from the CLL14 trial in which patients received a 12-month treatment regimen. The majority of patients receiving VENCLEXTA in the trial remained progression-free at two years."

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For patients with CLL or SLL, Venclexta comes in a five-week dose starting pack, with ramp-up schedule. The first four weeks, provided in the starting pack, increase from 20 mg, to 50 mg, then 100 mg, and finally 200 mg. At week five and beyond, the dosage is increased to 400 mg,  using 100-mg tablets that are supplied in bottles. 

Venclexta should be taken orally, once daily with a meal and water. Tablets should not be chewed, crushed, or broken. The drug may also be used as a prophylaxis treatment if a patient experiences tumor lysis syndrome.

Venetoclax is contraindicated in patients with CLL/SLL concomitantly using CYP3A inhibitors at initiation and during the ramp-up dosage phase. 

In patients with CLL/SLL, the most common adverse reactions with venetoclax, either as a solo treatment or in combination with obinutuzumab or rituximab, included neutropenia, thrombocytopenia, anemia, diarrhea, nausea, upper respiratory tract infection, cough, musculoskeletal pain, fatigue, and edema. 

 

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