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US rejects MSD/Eisai's Keytruda Lenvima combo
pharmatimes
July 10, 2020
MSD and Eisai have received a complete response letter (CRL) from the US Food and Drug Administration rejecting accelerated approval of a combination of Keytruda (pembrolizumab) and Lenvima (lenvatinib) for liver cancer.
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US FDA declines to approve Merck and Eisai’s liver cancer combo therapy
expresspharma
July 10, 2020
The FDA's complete response letter cited lack of sufficient evidence that the Keytruda-Lenvima combination therapy had a meaningful advantage over available treatments for the condition.
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FDA Approves Keytruda for First-Line Treatment of MSI-H/dMMR Colorectal Cancer
americanpharmaceuticalreview
July 09, 2020
The Food and Drug Administration (FDA) approved pembrolizumab (KEYTRUDA, Merck) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
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MSD's Keytruda bags approval for new skin cancer indication
pharmatimes
June 29, 2020
MSD's Keytruda (pembrolizumab) has been cleared for use in the US as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) not curable by surgery or radiation.
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MSD's Keytruda misses advanced bladder cancer goal
pharmatimes
June 16, 2020
MSD's Keytruda (pembrolizumab) has failed to hit key goals in a trial assessing its potential as a first-line treatment for bladder cancer.
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MSD's Keytruda doubles PFS in bowel cancer subset
pharmatimes
May 29, 2020
MSD's immunotherapy Keytruda (pembrolizumab) more than doubled progression free survival in patients with a specific subtype of advanced bowel cancer, when compared with chemotherapy.
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NICE hits Keytruda with ‘no’ for urothelial cancer
pharmatimes
March 13, 2020
The National Institute for Health and Care Excellence (NICE) has published a new final draft guidance recommending against the routine use of Keytruda (pembrolizumab) locally advanced or metastatic urothelial carcinoma.
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Keytruda improves PFS in classical Hodgkin lymphoma
pharmatimes
March 06, 2020
MSD has announced more Keytruda (pembrolizumab) results, this time for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
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NICE requests more data on Keytruda for head and neck cancer treatment
europeanpharmaceuticalreview
January 17, 2020
NICE has asked for more information on Keytruda (pembrolizumab) for untreated metastatic or unresectable recurrent squamous cell head and neck cancer due to uncertainty over clinical trial evidence.
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FDA approves Keytruda for patients with high-risk, non-muscle invasive bladder cancer
europeanpharmaceuticalreview
January 14, 2020
Keytruda is the first anti-PD-1 monoclonal antibody therapy approved for patients with BCG-unresponsive, high-risk, non-muscle invasive bladder cancer.