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New FDA Approval for VENCLEXTA® (venetoclax tablets)

On May 15, 2019, VENCLEXTA® (venetoclax tablets) was approved by the US Food and Drug Administration (FDA) for the first-line treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

VENCLEXTA is also approved in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

This indication is approved under accelerated approval based on response rates. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

VENCLEXTA Access Solutions is your resource for access and reimbursement support after VENCLEXTA is prescribed. VENCLEXTA Access Solutions can help your patients and practice by providing:

  • Benefits investigations (BIs)
  • Prior authorization (PA) resources
  • Information about authorized specialty pharmacies (SPs) and specialty   distributors
  • Sample billing and coding information
  • Resources for denials and appeals
  • Patient assistance options

A list of authorized SPs and specialty distributors is available at Genentech-Access.com/VENCLEXTA.

Please see full Prescribing Information for Indication and additional Important Safety Information.

Venclexta Billing and Coding