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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Subcutaneous Daratumumab Approved for Newly Diagnosed Light Chain Amyloidosis

The FDA has granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro®, Janssen Biotech, Inc.) in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) for the treatment of patients with newly diagnosed amyloid light chain (AL) amyloidosis. "As immunoglobulin light chains present in AL amyloidosis are considered to be toxic to involved organs, especially the heart, rapid and deep hematologic remission with reduction of these light chains with frontline ther...
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Anaplastic Large Cell Lymphoma: Crizotinib Approved for Younger Patients

Crizotinib (Xalkori®, Pfizer) is now FDA approved for the treatment of pediatric patients age one year and older and young adult patients with relapsed/refractory systemic ALK-positive anaplastic large cell lymphoma (ALCL). The approval was based on Study ADVL0912 (NCT00939770), a single-arm phase 1/2 trial. "Various human cancers have ALK gene translocations, amplifications, or oncogenic mutations, such as ALCL, inflammatory myofibroblastic tumors, non-small cell lung cancer (NSCLC), and neurob...
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Darolutamide for Castration-Resistant Prostate Cancer: FDA Updates Prescribing Info

The FDA has added new overall survival and other secondary outcome data to the prescribing information for darolutamide (Nubeqa®, Bayer), an androgen receptor inhibitor which was approved for the treatment of nonmetastatic castration-resistant prostate cancer (CRPC) in 2019. The updates were based on the final analysis of the phase 3 ARAMIS trial (NCT02200614), led by first author Karim Fizazi, MD, Head of the Department of Cancer Medicine at the Institut Gustave Roussy in Villejuif, France. The...
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Neal Shore, MD, FACS: Relugolix Approval for Advanced Prostate Cancer

Relugolix (OrgovyxTM, Myovant Sciences) was recently FDA approved as the first oral hormone therapy for patients with advanced prostate cancer. In this interview, Neal Shore, MD, FACS, Medical Director of the Carolina Urologic Research Center and lead investigator of the HERO trial, on which the approval was based, speaks with i3 Health about the approval's significance and the future of treatment for patients with this disease. Can you comment on the significance of the approval of relugolix fo...
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