RE: Avacta will be partnering up or has already partnered up with a big pharma2 Oct 2024 09:59
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“ A new treatment for women with a type of advanced breast cancer has been provisionally rejected by the NHS spending watchdog.
In draft guidance the National Institute for Health and Care Excellence (NICE) said it does not recommend elacestrant for treating oestrogen receptor-positive, human epidermal growth factor receptor 2-negative (HER2-), locally advanced or metastatic breast cancer with an activating ESR1 mutation.
There are currently no targeted treatments available on the NHS for this type of advanced breast cancer that has an ESR1 mutation.
The company proposed that elacestrant (also called Korserdu) is used when the cancer has got worse after at least 12 months of treatment with hormone therapy and a CDK 4/6 inhibitor.
The charity Breast Cancer Now said that elacestrant could bring “precious additional time with loved ones” before disease progression.
But NICE said it is “ready to work with” the manufacturer to address any “uncertainty in evidence” and has requested further clarification and analyses on its effectiveness ahead of their next meeting on 12 November.
The draft guidance is open for public consultation until 22 October.
Helen Knight, director of health technology evaluation at NICE, said: “The main area of uncertainty the committee had to contend with was the estimates for how long elacestrant stopped the disease from getting worse compared with current clinical practice.
“It also meant the committee was unable to confirm at this stage whether a severity modifier could be applied.”
Claire Rowney, chief executive at Breast Cancer Now, said: “We understand that NICE has concerns about uncertainties in the data on the clinical effectiveness of elacestrant, and we urge NICE and Menarini Stemline [the manufacturer] to work closely together to explore all solutions to resolve these issues and see the provisional decision reversed.
“Unless this happens, patients could be denied the precious chance of being offered this targeted treatment option that gives them more time before their cancer progresses.”
It is estimated around 1,000 people would be eligible for treatment with elacestrant if NICE were to recommend it.”