Application Detail

Status

Closed

Description of Medical Service

Venetoclax is a BCL-2 inhibitor listed on the Australian Register of Therapeutic Goods (ARTG). The TGA-approved indications are as a treatment for:
• Patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) with 17p-del, or
• Patients with relapsed or refractory CLL for whom there are no other suitable treatment options.

Description of Medical Condition

Chronic lymphoid leukaemia (CLL), which is also known as B-cell Chronic lymphoid leukaemia (B-CLL), is a specific type of leukaemia, a group of cancers usually originated in bone marrow and resulting in abnormally high numbers of white blood cells. The presence of a 17p deletion is associated with a significantly poorer prognosis, and patients harbouring a 17p deletion show marked resistance to genotoxic chemotherapies recommended as first-line treatment for CLL.

Reason for Application

Amendment to MBS item

Medical Service Type

Co-dependent technology

Previous Application Number

Not Applicable

Associated Documentation

Application Form

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PICO Confirmation

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Assessment Report

-

Public Summary Document

Public Summary Document - updated (PDF 867 KB)
Public Summary Document - updated (Word 79 KB)

Meetings for this Application

PASC

-

ESC

8 June 2017

MSAC

6 - 7 April 2017
27 July 2017
22-23 November 2018