News
Keytruda Approved as First-Line Treatment for Persistent, Recurrent or Metastatic Cervical Cancer
The approval was based on data from the phase 3 KEYNOTE-826 trial.
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Drugs in the Pipeline
Tisotumab Vedotin Under Review for Recurrent or Metastatic Cervical Cancer
Tisotumab vedotin is an investigational antibody-drug conjugate targeted to tissue factor.
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Keytruda Approved as First-Line Treatment of MSI-H or dMMR Colorectal Cancer
The FDA has approved Keytruda (pembrolizumab; Merck), a programmed death receptor-1 -blocking antibody, as monotherapy 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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Immunotherapy Regimen Approved for Hepatocellular Carcinoma
The FDA has approved Tecentriq® in combination with Avastin® for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
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Lynparza Plus Bevacizumab Approved for First-Line Maintenance in HRD-Positive Advanced Ovarian Cancer
The FDA has approved Lynparza® for use in combination with bevacizumab as first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer
Generics News
Pfizer Announces Launch of Three Biosimilar Cancer Treatments
Pfizer announced the launch of 3 new biosimilars: Zirabev (bevacizumab-bvzr), Ruxience (rituximab-pvvr) and Trazimera (trastuzumab-qyyp). Zirabev, a biosimilar to Avastin (bevacizumab; Genentech), is available for the treatment of 5 types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent…
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First-Line Treatments for Advanced EGFR-Mutated NSCLC Compared
In patients with advanced epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), treatment with osimertinib and gefitinib plus pemetrexed-based chemotherapy was found to be superior to other first-line therapies, according to a systematic review and network meta-analysis published in the BMJ. For this investigation, study authors searched various databases from inception through May…
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Biosimilars Mvasi, Kanjinti Now Available in the US
Mvasi (bevacizumab-awwb), a biosimilar to Avastin (bevacizumab), and Kanjinti (trastuzumab-anns), a biosimilar to Herceptin (trastuzumab) have been made available by Amgen and Allergan. Mvasi, a vascular endothelial growth factor inhibitor, is indicated to treat: Metastatic colorectal cancer, in combination with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment. Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan-…
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Biosimilar Zirabev Gets FDA Approval for 5 Types of Cancer
The FDA has approved Zirabev (bevacizumab-bvzr; Pfizer), a biosimilar to Avastin (bevacizumab; Genentech).
News
Mirvetuximab Soravtansine Data Lacking for FDA’s Accelerated Approval in Ovarian CA
The Food and Drug Administration (FDA) has recommended that ImmunoGen, Inc. conduct a new phase 3 randomized trial to evaluate the safety and efficacy of mirvetuximab soravtansine (IMGN853) in patients with high folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer.
