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Merck’s Keytruda obtains EC approval as adjuvant therapy for kidney cancer
Pharmaceutical-Technology
January 28, 2022
In a Phase III trial, Keytruda lowered the disease recurrence or mortality risk by 32% versus placebo.
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FDA approves Keytruda plus Lenvima for advanced kidney cancer
pharmatimes
August 13, 2021
The US Food and Drug Administration (FDA) has approved a combination of MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) plus Eisai’s Lenvima (lenvatinib) for the first-line treatment of adult patients with advanced renal cell carcinoma ...
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Merck’s Keytruda receives FDA priority review in renal cell cancer
pharmaceutical-technology
August 12, 2021
The US Food and Drug Administration (FDA) has granted priority review to Merck’s (MSD) new supplemental biologics license application (sBLA) for Keytruda (pembrolizumab) as adjuvant therapy to treat renal cell carcinoma (RCC) patients.
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Priority review for Merck & Co’s belzutifan in rare kidney cancer subset
pharmatimes
March 18, 2021
Merck & Co has received a priority review from the US Food and Drug Administration (FDA) for its potential rare kidney cancer treatment belzutifan.
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FDA Approves Tivozanib for Relapsed/Refractory Advanced Renal Cell Carcinoma
americanpharmaceuticalreview
March 18, 2021
The U.S. Food and Drug Administration (FDA) approved tivozanib (Fotivda, AVEO Pharmaceuticals), a kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
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USFDA grants priority review to Merck’s NDA for HIF-2α inhibitor Belzutifan
pharmaceutical-business-review
March 17, 2021
The US Food and Drug Administration (FDA) has granted priority review for Merck’s New Drug Application (NDA) for the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor belzutifan.
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FDA Approves Nivolumab Plus Cabozantinib for Advanced Renal Cell Carcinoma
americanpharmaceuticalreview
January 28, 2021
The U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo, Bristol-Myers Squibb) and cabozantinib (Cabometyx, Exelixis) as first-line treatment for patients with advanced renal cell carcinoma (RCC).
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Lenvima plus Keytruda achieves primary endpoints in trial for RCC
europeanpharmaceuticalreview
November 12, 2020
Lenvima and Keytruda has demonstrated positive top-line results in a Phase III trial in patients with advanced renal cell carcinoma.
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AVEO Oncology announces FDA acceptance for filing of an NDA for Tivozanib as treatment of relapsed o
pharmaceutical-business-review
June 04, 2020
AVEO Oncology announced that the U.S. Food and Drug Administration (FDA) accepted for filing its New Drug Application (NDA) seeking approval for tivozanib ...
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Opdivo/Yervoy continues to impress in kidney cancer
pharmatimes
March 10, 2020
Bristol-Myers Squibb has announced that its Opdivo (nivolumab) and Yervoy (ipilimumab) combo has demonstrated superior overall survival, complete response rates and objective response rates at 42 months ...