11/7/2023 0 Comments Keynote 590 fda![]() The drug is also approved in Canada and Australia. In October 2021, the EC also approved the drug in combination with chemotherapy for the first-line treatment of locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) in adults.īased on the results of the KEYNOTE-355 Phase III trial, the approval enables the combination with Keytruda to be marketed in all 27 European Union member states, Iceland, Lichtenstein, Norway and Northern Ireland. ![]() In October 2021, the FDA approved Keytruda plus chemotherapy, either with or without bevacizumab, for treating patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1 (combined positive score greater than or equal to 1 based on the results of the Phase III KEYNOTE-826 study. Keytruda has been authorised for eight indications in five different types of cancer in China. The approval was given based on findings from the pivotal phase III KEYNOTE-590 trial. In September 2021, China’s National Medical Products Administration (NMPA) approved Keytruda, together with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of patients with advanced oesophageal or gastroesophageal junction (GEJ) carcinoma. In combination with Lenvima ® (lenvatinib), the drug received FDA approval for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC), based on the results of the pivotal phase III KEYNOTE-581 study. In August 2021, Keytruda received approval for treating patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy in the US. In July 2021, Keytruda received FDA approval for high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy, based on the results of the KEYNOTE-522 clinical trial. In January 2019, the Japan Pharmaceuticals and Medical Devices Agency (PMDA) granted five approvals to Keytruda as either a monotherapy or in combination for the treatment of advanced NSCLC, MSI-H and melanoma. The drug received approval from the China National Drug Administration (CNDA) for the treatment of advanced melanoma in July 2018. The European Commission (EC) approved Keytruda for the treatment of advanced NSCLC in January 2017. Keytruda has also received FDA approval for indications including advanced non-small cell lung cancer (NSCLC), hepatocellular carcinoma, microsatellite instability-high (MSI-H) cancer, small cell lung cancer, head and neck squamous cell cancer (HNSCC), classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, colorectal cancer, gastric cancer, endometrial carcinoma, tumour mutational burden-high (TMB-H) cancer, cutaneous squamous cell carcinoma and Merkel cell carcinoma.
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