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Using a blood sample, the test is able to analyze more than 300 cancer-associated genes for alterations.
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The approval was based on data from the CASPIAN study, an active-controlled, open-label trial that investigated the combination of durvalumab plus chemotherapy vs chemotherapy alone.
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The Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab; Merck) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
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In patients with naïve advanced non-small cell lung cancer (NSCLC) and high PD-LI expression who are treated with pembrolizumab, the use of intravenous (IV) antibiotics may negatively impact progression free survival (PFS) and overall survival, according to research presented at the IASLC 2019 World Conference on Lung Cancer. To evaluate the effect of antibiotics on…
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The FDA approved Keytruda for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test
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The approval was based on data from 83 patients with SCLC who were enrolled in either the KEYNOTE-028 or KEYNOTE-158 trials.
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The FDA has approved Cyramza (ramucirumab; Lilly) for use as a single agent in the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha fetoprotein (AFP) of ≥400ng/mL and have been treated with sorafenib.
Drugs in the Pipeline
A PDUFA target date of November 24, 2022 has been set for the application.
Features
To prove clinical benefit, the FDA requires manufacturers to conduct confirmatory trials, also known as a phase 4 studies.
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Lorbrena is a third generation ALK tyrosine kinase inhibitor.