Drugs in the Pipeline
Mirvetuximab soravtansine is an antibody-drug conjugate comprised of a FRα-binding antibody, a cleavable linker, and a potent tubulin-targeting agent.
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The approval was based on data demonstrating that the biosimilar product and the reference product were highly similar, and that there were no clinically meaningful differences between the agents.
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The approval was based on data from the phase 3 KEYNOTE-826 trial.
Drugs in the Pipeline
Tisotumab vedotin is an investigational antibody-drug conjugate targeted to tissue factor.
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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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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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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 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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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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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-…
