keytruda
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Sanofi CEO: We Don’t Have a Leaky Bathtub
In a media briefing during the J.P. Morgan Healthcare Conference in San Francisco, Paul Hudson said unlike Sanofi, large pharma companies with top-selling drugs have a portfolio akin to a leaky bathtub because in a few years, they will have to replace much of that revenue as drug patents expire.
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Merck, Eisai drug combo nabs FDA nod as first-line kidney cancer therapy
FDA approval of a therapy that pairs drugs from Eisai and Merck allows the combination to become a first-line treatment for renal cell carcinoma. It’s the latest approval for the partners, which have been working together since 2018.
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Merck paying $2.75B for cancer therapeutics firm VelosBio
The deal will broaden Merck’s oncology portfolio as it picks up an antibody-drug conjugate, a class of biological drugs that target tumor cells even as the pharma giant jettisons other parts of its business
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Merck cancer immunotherapy drug gets expansion to biomarker-based labeling
The FDA approved Keytruda as a single agent for patients with first-line metastatic or unresectable colorectal cancer that carries the biomarker MSI-H or dMMR. The drug was the first to win a biomarker-based, tumor-agnostic label, in 2017.
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AstraZeneca reports promising lung cancer results from Phase III immunotherapy drug trial
The company said Imfinzi and chemotherapy, with or without tremelimumab, extended progression-free survival in first-line non-small cell lung cancer versus chemotherapy, setting up Imfinzi as a potential competitor to Merck’s Keytruda. Overall survival data are expected next year.
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Merck, Eisai cancer drugs win approval in three countries under new regulatory initiative
Drug regulators in the U.S., Canada and Australia simultaneously approved Merck’s Keytruda and Eisai’s Lenvima for advanced endometrial carcinoma following a collaborative review under a program called Project Orbis.
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Another study shows liquid biopsy can detect cancer immunotherapy biomarker
The study, by Personal Genome Diagnostics and academic researchers, was able to predict responses to checkpoint inhibitor therapy in patients with MSI-H and high tumor mutational burden.
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Moderna builds up clinical pipeline as multiple new drugs enter Phase I testing
The company also advanced a therapy, a personalized cancer vaccine in melanoma, into a Phase II study as the first patient in the trial consented.
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Study finds Guardant’s liquid biopsy adept at detecting biomarker used by Merck immunotherapy drug
The study, by US and Korean researchers, found Guardant360’s detection of MSI-H/dMMR “highly concordant” with that of standard tissue biopsy, including in a subset of gastric cancer patients who responded to immunotherapy.
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Trayt Health Seeks to Increase Access to Diagnoses and Treatments
CEO Malekeh Amini explains how Trayt Health can bridge the gap for patients seeking neurological care.
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Merck’s Keytruda fails in Phase III triple-negative breast cancer study, but has a few more chances
The KEYNOTE-119 study failed to show a survival benefit in TNBC patients. The news comes two months after the FDA gave accelerated approval to a rival, Roche’s Tecentriq.
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Merck’s Keytruda flunks liver cancer confirmatory trial 3 months after accelerated approval
The company said it had shared data from the Phase III study with the FDA. However, per FDA regulations, there is a risk that the accelerated approval for hepatocellular carcinoma could be withdrawn.
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Three PD-L1 inhibitors see setbacks in their development
Two drugs – Pfizer and Merck KGaA’s Bavencio and AstraZeneca’s Imfinzi – saw Phase III trials fail, while anticipated negative results prompted Roche to withdraw Tecentriq from regulatory review.
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Cancer immunotherapy pioneers win Nobel Prize in Medicine
Kyoto University’s Tasuku Honjo and MD Anderson’s James Allison will share the prize for work that led to immunotherapy drugs like Keytruda and Yervoy.
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FDA grants second approval under new expedited-review pilot program
Merck’s Keytruda marks the second label expansion, after Novartis’ Kisqali, under Real-Time Oncology Review program.
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J&J puts the brakes on immunotherapy combination studies
Janssen halts lung cancer and myeloma trials, citing lack of clinical benefit and greater number of patient deaths in combo arm.