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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.
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The FDA has approved Cyramza (ramucirumab; Lilly) in combination with erlotinib, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
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The Food and Drug Administration (FDA) has approved the combination of Opdivo (nivolumab; Bristol Myers Squibb) plus Yervoy (ipilimumab; Bristol Myers Squibb) and 2 cycles of platinum-doublet chemotherapy, for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
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The FDA has approved the combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
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The Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee voted 6 to 5 that ramucirumab (Cyramza; Lilly) plus erlotinib demonstrated a favorable benefit/risk profile for patients with untreated metastatic epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer (NSCLC). The vote was based on data from the phase 3 RELAY study (N=449), which evaluated…
