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HCM News
HCM Events
Hutchmed's Orpathys Receives Conditional Approval from NMPA
Hutchmed announced that the new drug application, or NDA, for Orpathys has been granted conditional approval by the China National Medical Products Administration, or NMPA, for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification who have failed at least two prior systemic treatments.
Hutchmed and Innovent Biologics Announce New Drug Application Approval
Hutchmed and Innovent Biologics jointly announce that the New Drug Application for the combination of Elunate and Tyvyt has been granted approval by the China National Medical Products Administration for the treatment of patients with locally advanced or metastatic renal cell carcinoma who have failed prior vascular endothelial growth factor receptor-tyrosine kinase inhibitors therapy and have not received programmed death receptor-1 or programmed death-ligand 1 inhibitor therapy in the first-line setting.
Innovent Biologics and Hutchmed Announce New Drug Approval
Innovent Biologics and Hutchmed jointly announce that the new drug application for the combination of Tyvyt and Elunate has been granted approval by the China National Medical Products Administration for the treatment of patients with locally advanced or metastatic renal cell carcinoma who have failed prior vascular endothelial growth factor receptor-tyrosine kinase inhibitors therapy and have not received programmed death receptor-1 or programmed death-ligand 1 inhibitor therapy in the first-line setting.
Hutchmed's Sovleplenib New Drug Application Accepted for Priority Review
Hutchmed announces that the New Drug Application for sovleplenib for the treatment of adult patients with warm antibody autoimmune hemolytic anemia who have had an insufficient response to at least one previous glucocorticoid treatment has been accepted for review and granted priority review by the China National Medical Products Administration. Sovleplenib is a novel, selective, oral inhibitor targeting spleen tyrosine kinase, being developed for the treatment of immune diseases and hematological malignancies.
Hutchmed Announces Withdrawal of Tazverik in China
Hutchmed (HCM) announced an update regarding Tazverik, an oncology therapy licensed from Epizyme, an Ipsen (IPSEY) company, in China. Epizyme is the marketing authorization holder of Tazverik in the Chinese mainland, for which Hutchmed acts as the domestic agent/licensee. Ipsen has informed Hutchmed that it is voluntarily withdrawing Tazverik in the U.S. As a result, steps have been taken to initiate the market withdrawal and product recall in China. Consequently, Hutchmed has initiated a withdrawal and product recall from the Chinese mainland, Hong Kong and Macau, and is discontinuing all active tazemetostat clinical trials. Existing patients should consult their treating physicians immediately to discuss their treatment options. Ipsen is the sponsor of the ongoing Phase Ib/III SYMPHONY-1 trial. As informed by Ipsen, following a review of emerging data from SYMPHONY-1, the study Independent Data Monitoring Committee advised that, based on adverse events of secondary hematologic malignancies, the risks may outweigh potential benefits for patients within this treatment regimen. As a result of these data, Ipsen is withdrawing Tazverik effective immediately, including both for follicular lymphoma and epithelioid sarcoma. Ipsen has announced that, in addition to withdrawing Tazverik from the market, Ipsen has initiated steps to stop treatment with tazemetostat for all patients currently enrolled in the ongoing SYMPHONY-1 trial. All participants will receive standard of care, lenalidomide plus rituximab only. The study will remain open, with no further enrollment, to continue the long-term safety follow-up of all participants. Ipsen is also discontinuing all active tazemetostat clinical trials and expanded access programs. Ipsen is working with the FDA on the next steps to execute the withdrawal of Tazverik and provide all necessary information to complete this process.
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