Kidney cancer charity slams NICE rejection of Keytruda/Inlyta
NICE says the combination’s cost-effectiveness estimate is higher than what is considered acceptable for NHS use
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Tag: Inlyta
EMA positive opinion granted for Keytruda combo
The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorisation.
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MHRA gives Bavencio, Inlyta combo Early Access to Medicines status
The opinion is for the indication of RCC, the most common kind of kidney cancer found in adults.
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FDA approval for Bavencio combo in advanced RCC
The decision was based on positive results from the Phase III JAVELIN Renal 101 study.
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Keytruda combo wins FDA approval for RCC
The approval is based on results of the KEYNOTE-426 study, in which Keytruda in combination with Inlyta was found to reduce the risk of death by nearly half compared to Sutent.
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Bavencio combo gets FDA priority review for kidney cancer
The US Food and Drug Administration has accepted for priority review a supplemental Biologics License Application for Merck’s Bavencio (avelumab) in combination with Inlyta (axitinib) for patients with advanced renal cell carcinoma (RCC).
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Keytruda/Inlyta combo shows significant survival benefit in kidney cancer trial
A pivotal Phase III trial investigating a combination of MSD’s anti-PD-1 therapy Keytruda and Pfizer’s tyrosine kinase inhibitor Inlyta has shown a significant benefit on both overall (OS) and progression-free survival (PFS) in patients with kidney cancer.
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Merck, Pfizer intend to file Bavencio, Inlyta combo
Merck KGaA and Pfizer say they intend to seek US approval of a combination of Bavencio and Inlyta for kidney cancer on the back of progression-free survival data from a late-stage trial.
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Pfizer pulls plug on Inlyta trial
Pfizer is terminating a late-stage trial assessing Inlyta in patients at risk of kidney cancer recurrence after an interim analysis showed that it was highly unlikely the drug would offer any benefit in this setting.
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