Durvalumab Approval Withdrawn for Urothelial Carcinoma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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Trilaciclib Approved for Chemo-Induced Myelosuppression in Small-Cell Lung Cancer

The FDA has approved trilaciclib (CoselaTM, G1 Therapeutics) for the prevention of myelosuppression in patients receiving chemotherapy for extensive-stage small-cell lung cancer (SCLC). Occurring when chemotherapy agents damage the bone marrow, myelosuppression decreases the production of red blood cells, white blood cells, and platelets, causing patients to experience fatigue, bleeding, and increased risk of infection. "Chemotherapy is a mainstay of cancer treatment; however, its side effects, ...
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Subcutaneous Daratumumab for Light Chain Amyloidosis: Efstathios Kastritis, MD

Recently, the FDA approved subcutaneous daratumumab in combination with bortezomib/cyclophosphamide/dexamethasone (VCd) for the treatment of patients with newly diagnosed amyloid light chain (AL) amyloidosis. In this interview, Efstathios Kastritis, MD, Associate Professor of Clinical Therapeutics at the National and Kapodistrian University of Athens and senior author of ANDROMEDA (NCT03201965), the study on which the approval was based, discusses the challenges of treating patients with AL...
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Cemiplimab-rwlc Approved for Locally Advanced/Metastatic Basal Cell Carcinoma

The FDA has now approved cemiplimab-rwlc (Libtayo®, Regeneron Pharmaceuticals) for patients with locally advanced or metastatic basal cell carcinoma (BCC) who received prior treatment with a hedgehog pathway inhibitor (HHI) and those who are ineligible for HHI therapy. Cemiplimab is the first immunotherapy to be approved for patients with advanced BCC. "Cemiplimab, an antibody to programmed cell death protein 1 (PD-1), is an established therapy approved for treatment of advanced cutaneous squamo...
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Lisocabtagene Maraleucel Approved for Relapsed/Refractory Large B-Cell Lymphomas

The FDA has approved lisocabtagene maraleucel (Breyanzi®, Juno Therapeutics) for patients with relapsed/refractory large B-cell lymphomas, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DCBLC transformed from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, and grade 3B follicular lymphoma, who have progressive disease following at least two prior lines of systemic therapy. Lisocabtagene maraleucel is not indicated for patie...
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