Melphalan Flufenamide Approved for Triple-Class Refractory Multiple Myeloma

The FDA has approved melphalan flufenamide (Pepaxto®, Oncopeptides AB) in combination with dexamethasone for the treatment of patients with relapsed and refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy and whose disease is refractory to at least one CD38–directed monoclonal antibody, one proteasome inhibitor, and one immunomodulatory agent. "Melphalan flufenamide (melflufen) is a first-in-class peptide-drug conjugate that targets aminopeptidases and rapid...
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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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Kohei Shitara, MD: Fam-Trastuzumab Deruxtecan-Nxki for Gastric Cancer

Fam-trastuzumab deruxtecan-nxki (Enhertu®, Daiichi Sankyo) has recently been FDA approved for the treatment of adult patients with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal adenocarcinoma previously treated with a trastuzumab-based regimen. In this interview with i3 Health, Kohei Shitara, MD, Chief of the Department of Gastrointestinal Oncology at the National Cancer Center Hospital East in Kashiwa, Japan, and lead investigator of the phase 3 DESTINY-Gastric01 trial, on which the approval was based, shares his insights on this approval, on the challenges of treating this patient population, and on the future of treatment for patients with gastric or gastroesophageal adenocarcinoma.

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Fam-Trastuzumab Deruxtecan-Nxki Approved for Advanced Gastric Cancer

The FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu®, Daiichi Sankyo) for the treatment of adult patients with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal adenocarcinoma previously treated with a trastuzumab-based regimen. Approval was based on DESTINY-Gastric01 (NCT03329690), a multicenter, open-label, randomized trial. For this study, led by study author Kohei Shitara, MD, Chief of the Department of Gastrointestinal ...
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Expanded Approval for Selinexor for Multiple Myeloma

The FDA has recently expanded approval for selinexor (XpovioTM, Karyopharm Therapeutics) to include combination therapy with bortezomib and dexamethasone for adults with multiple myeloma who have received at least one previous line of therapy. Previously, selinexor was approved in combination with dexamethasone for patients with multiple myeloma who have received four previous lines of therapy, including two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal...
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