August 8, 2022

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AbbVie leukemia drug Venclyxto rejected by UK NICE

AbbVie leukemia drug Venclyxto rejected by UK NICE



 

AbbVie leukemia drug Venclyxto rejected by UK NICE.


The UK’s National Institute for Health and Clinical Excellence ( NICE ) recently issued draft guidelines not recommending the use of biotech giant Abbvie ‘s breakthrough cancer drug Venclyxto ( venetoclax ) in the UK’s National Health Service ( NHS ) for Treatment of patients with specific types of chronic lymphocytic leukemia ( CLL ).

Specifically: CLL patients with 17p deletion mutations or TP53 mutations who are ineligible or who have received B cell receptor signaling pathway inhibitors but have failed treatment , and those who do not have 17p deletion Mutated or TP53 -mutated CLL patients who have failed prior chemotherapy – immunotherapy and B -cell receptor signaling pathway inhibitors .

 

AbbVie leukemia drug Venclyxto rejected by UK NICE

 

This decision by NICE is undoubtedly a huge blow for AbbVie, and it is also very disappointing for the CLL patient group in the UK. It is estimated that up to 50% of patients with CLL in the UK are refractory to current standard treatment regimens and face survival as short as 3 months.

 

According to AbbVie, in clinical trials, 72 % of patients treated with Venclyxto had no disease progression after one year of treatment; among patients with CLL who had previously received treatment and had a 17p deletion mutation , the median disease progression-free Survival is more than 27 months.However, NICE ‘s independent review committee concluded that AbbVie’s submission of evidence of Venclyxto ‘s clinical efficacy was significantly flawed and that the drug’s treatment benefits were uncertain.

 

In addition, Venclyxto has incremental cost-effectiveness ratios ( ICERs ) above the normal acceptable maximum ICER range ( £ 20,000-30,000 per quality-adjusted life-year [QALY] ) compared to best supportive care ( BSC ) , does not have Cost-effective and therefore not considering Venclyxto for the UK National Health Service ( NHS ).

 

Chronic lymphocytic leukemia ( CLL ) is the most common type of leukemia in the adult population. It is estimated that in the UK, there are nearly 3,500 new cases of CLL each year .

Thankfully, Venclyxto is available for CLL patients in the UK through the Early Access to Medicines Scheme ( EAMS ) .

 

EAMS aims to address unmet medical needs by giving patients access to medicines that are not yet licensed in Europe; however, only a few medicines have entered EAMS so far .

Venclyxto , the first BCL-2 inhibitor approved globally, was granted accelerated approval by the U.S. Food and Drug Administration ( FDA ) in April 2016 ; in Europe, Venclyxto was approved in December 2016 .

The launch of the drug marks a major advance in the clinical treatment of chronic lymphocytic leukemia ( CLL ).venetoclax is an oral inhibitor of B – cell lymphoma factor -2 ( BCL-2 ) , which plays an important role in apoptosis (programmed cell death), preventing the apoptosis of some cells, including lymphocytes. death, and is overexpressed in some types of cancer, and is associated with the development of drug resistance.

venetoclax is designed to selectively inhibit the function of BCL-2 , restore the cell’s communication system, allow cancer cells to self-destruct, and achieve the purpose of treating tumors.

 

 

 

AbbVie leukemia drug Venclyxto rejected by UK NICE

(source:internet, reference only)


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