Durvalumab Approved for Treatment of Biliary Tract Cancer

The FDA has approved durvalumab (Imfinzi®, AstraZeneca UK Limited) in combination with gemcitabine and cisplatin for treatment of locally advanced or metastatic biliary tract cancer. "Biliary tract cancer, a heterogeneous group of malignancies that includes intrahepatic and extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of Vater cancer, is typically diagnosed at advanced stages, for which curative surgery is not feasible and prognosis is poor," wrote Do-Youn Oh, MD, PhD, Profes...

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Durvalumab Approval Withdrawn for Urothelial Carcinoma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 Improves Survival in Advanced Lung Cancer

A new study has demonstrated that durvalumab (Imfinzi®, AstraZeneca) improves survival for patients with stage III, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed after chemoradiotherapy. Durvalumab, an intravenously administered immune checkpoint inhibitor, was approved in February by the United States Food and Drug Administration (FDA) as a standard-of-care treatment for this indication. It works by blocking programmed cell death ligand 1 (PD-L1), a protein fo...

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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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Extensive-Stage SCLC: Adding Durvalumab to Platinum/Etoposide Improves Survival

The phase 3 CASPIAN trial reports that adding durvalumab (Imfinzi®, AstraZeneca) to etoposide and a platinum therapy improves overall survival in patients with extensive-stage small-cell lung cancer (ES-SCLC). Many patients with small-cell lung cancer do not receive a diagnosis until after their disease has already reached the extensive stage, at which point the prognosis is poor. Because immunotherapy has shown some activity in ES-SCLC, the researchers of the CASPIAN trial assessed the efficacy...

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