Pfizer announced Thursday that the UK's National Institute for Health and Care Excellence has recommended the CDK 4/6 inhibitor Ibrance (palbociclib) through the Cancer Drugs Fund for use in combination with fulvestrant to treat women with HR-positive, HER2-negative, locally advanced or metastatic breast cancer who have received prior endocrine therapy. Olivia Ashman, oncology medical director for Pfizer in the UK, said "this outcome marks a significant milestone for the secondary breast cancer community."
Pfizer estimates that there are roughly 3200 women in England with the disease who could now be eligible for treatment with Ibrance, which was approved in Europe in 2016. The NICE recommendation is based on results from the Phase III PALOMA-3 trial, showing that the combination of Ibrance plus fulvestrant led to progression-free survival of 11.2 months in women who had received prior rounds of hormone therapy, compared with 4.6 months for those given fulvestrant alone.
In 2017, NICE came out against routine NHS funding for Ibrance in the first-line setting as the drug's cost was deemed "too high in relation to its potential benefits." However, the agency later backed Ibrance, as well as Novartis' CDK 4/6 inhibitor Kisqali (ribociclib), for use in previously untreated advanced breast cancer, saying the companies had agreed to provide an undisclosed discount, as well as more evidence of the drugs' effectiveness.
The combination of Ibrance plus fulvestrant was approved in Scotland in July. Pfizer reported last month that Ibrance sales climbed 25% in the third-quarter versus the same period last year, to $1.3 billion.
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