Main distributor to Brazil and Latin America for analytical reference substances  |  Welcome! Olá! Hola! Español  |  +1.919.484.7555
You are here: Home /FDA, Technology /US FDA approves Venclexta tablets to treat chronic lymphocytic leukaemia – Pharmaceutical Technology

US FDA approves Venclexta tablets to treat chronic lymphocytic leukaemia – Pharmaceutical Technology

by JMC on April 13, 2016

The US Food and Drug Administration (FDA) has approved a new drug Venclexta (venetoclax) to treat chronic lymphocytic leukaemia (CLL) in patients with a specific chromosomal abnormality.

Designed to help restore a cell’s ability to self-destruct, Venclexta is manufactured by AbbVie, and marketed by AbbVie and Genentech USA.

CLL is one of the most common types of leukaemia in adults and it is caused by the progressive accumulation of abnormal lymphocytes, a type of white blood cell.

The drug is said to be the first FDA-approved treatment that targets the B-cell lymphoma 2 (BCL-2) protein.

“BCL-2 inhibition is a novel mechanism that brings a new treatment option to patients who need additional therapies.”

This oral, once-daily medicine selectively inhibits the BCL-2 protein, which blocks apoptosis (programmed cell death) of cells, including some cancer cells, and can be over expressed in CLL cells.

Venclexta is indicated for daily use after detection of 17p deletion.

The 17p deletion is found in three to 10% of previously untreated cases and up to 30-50% of relapsed or refractory cases.

The deletion is a genomic alteration, in which a part of chromosome 17 is absent. Patients with this mutation typically have a poor prognosis and a life expectancy of less than two to three years.

AbbVie CEO Richard Gonzalez said: “The FDA’s approval of Venclexta marks a major milestone for our company, and more importantly for the patients diagnosed with relapsed / refractory CLL who harbour the 17p deletion.

“BCL-2 inhibition is a novel mechanism that brings a new treatment option to patients who need additional therapies.”

The efficacy of Venclexta was evaluated in a single-arm clinical trial, in which 106 patients with CLL who have a 17p deletion had received at least one prior therapy.

Venclexta clinical trial programme principal clinical investigator Matthew S. Davids said: “Results from the clinical trial programme show that Venclexta provides significant overall response among previously treated patients with CLL with 17p deletion.”

The US Food and Drug Administration (FDA) has approved a new drug Venclexta (venetoclax) to treat chronic lymphocytic leukaemia (CLL) in patients with a specific chromosomal abnormality.

Source: US FDA approves Venclexta tablets to treat chronic lymphocytic leukaemia – Pharmaceutical Technology

Previous post:

Next post: