UK NICE rejected Merck Keytruda for triple-negative breast cancer
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UK NICE rejected Merck Keytruda for triple-negative breast cancer.
Recently, UK National Institute for Health and Care Excellence (NICE) issued a draft guidance rejecting approval of Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) in combination with chemotherapy for the treatment of metastatic triple-negative breast cancer (mTNBC).
In the draft guidelines, the agency said that while the Keytruda-chemo combination was more effective than chemotherapy alone, its long-term benefits were uncertain.
In addition, there are no data on the combination of Keytruda + chemotherapy and Roche’s anti-PD-L1 therapy Tecentriq (atezolizumab) + chemotherapy. The latter was recommended by NICE for use in the UK National Service (NHS) in May 2020 for the treatment of mTNBC patients.
For Keytruda, NICE said, “its cost-benefit estimates are above what is generally considered acceptable by NHS resources”. But unusually, the agency wants to see more information from Merck on how Keytruda+ chemotherapy compares with Tecentriq+ chemotherapy.
Roche Tecentriq was previously rejected by NICE in the draft guidelines. However, NICE finally approved the drug for mTNBC after Roche agreed to give a confidential discount on Tecentriq’s pricing.
TNBC is an extremely aggressive form of breast cancer that lacks effective therapeutic targets and has few treatment options other than surgery, radiotherapy and chemotherapy.
TNBC tumors lack estrogen, progesterone, and HER2 receptor expression, and therefore cannot be treated with drugs targeting these biomarkers.
Merck said in a statement that it was disappointed with the NICE draft guidance, but that the company would work with NICE to try to find a way for patients to use Keytruda. It is estimated that, if eventually approved, the Keytruda+ chemotherapy regimen will bring a treatment option to about 600 mTNBC patients in the UK.
Reference:
NICE says no to Keytruda in triple-negative breast cancer
UK NICE rejected Merck Keytruda for triple-negative breast cancer
(source:internet, reference only)
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