Durvalumab Approval Withdrawn for Urothelial Carcinoma

Today, AstraZeneca voluntarily withdrew the indication of durvalumab (Imfinzi®, AstraZeneca) for patients with previously treated locally advanced or metastatic urothelial carcinoma based on results of the phase 3 DANUBE trial (NCT02516241), which did not meet its primary end points. The withdrawal does not affect durvalumab's indications for non-small cell lung cancer or for extensive stage small-cell lung cancer. Durvalumab, a human monoclonal antibody that binds to programmed death ligand 1 (...
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New Durvalumab Dosing Schedule Approved for Urothelial Carcinoma and Non-Small Cell Lung Cancer

 The FDA recently approved new doses of durvalumab (Imfinzi®, AstraZeneca) for the treatment of patients with previously treated advanced urothelial carcinoma and unresectable stage III non-small cell lung cancer. "Durvalumab, a selective, high-affinity, engineered human IgG1 mAb that blocks PD-L1 binding to PD-1 and CD80, is approved in the US, Japan, and several other countries for the treatment of patients with unresectable, stage III NSCLC whose disease has not progressed following conc...
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Durvalumab for Extensive-Stage Small-Cell Lung Cancer: Jonathan Goldman, MD

In this interview, Jonathan Goldman, MD, speaks with i3 Health about the recent FDA approval of durvalumab (Imfinzi®, AstraZeneca) in combination with platinum/etoposide for patients with extensive-stage small-cell lung cancer (ES-SCLC). The approval was based on CASPIAN, a phase 3 trial in which durvalumab/platinum/etoposide significantly increased median overall survival and produced a higher overall response rate compared with platinum/etoposide alone. Dr. Goldman, Associate Professor of Hema...
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Durvalumab Approved for Extensive-Stage SCLC

The FDA has approved durvalumab (Imfinzi®, AstraZeneca) in combination with either carboplatin/etoposide or cisplatin/etoposide for patients with previously untreated extensive-stage small-cell lung cancer (ES-SCLC). The approval was based on CASPIAN (NCT03043872), a phase 3 trial that enrolled 537 patients with untreated ES-SCLC. Patients were randomized in a 1:1:1 ratio to receive durvalumab/platinum/etoposide, durvalumab/tremelimumab/platinum/etoposide, or platinum/etoposide alone. Platinum-b...
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Durvalumab Plus Platinum/Etoposide for Extensive-Stage SCLC: Luis Paz-Ares, MD

Because most patients with small-cell lung cancer (SCLC) present with extensive-stage disease—in which the cancer has spread to both lungs or throughout the body—survival rates are poor, and there is a need to develop alternative treatments to improve outcomes. In their study now published in The Lancet, Luis Paz-Ares, MD, and colleagues found that in patients with extensive-stage SCLC (ES-SCLC), the addition of the immunotherapy drug durvalumab to a chemotherapy regimen of platinum/etoposide si...
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