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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FDA Approves Relugolix for Advanced Prostate Cancer

Relugolix (OrgovyxTM, Myovant Sciences) has been FDA approved for the treatment of patients with advanced prostate cancer. A gonadotropin-releasing hormone (GnRH) receptor antagonist, relugolix is the first oral hormone therapy to be approved for this disease. The approval was based on the phase 3 HERO trial (NCT03085095). "Relugolix was developed as an oral, highly selective, GnRH antagonist that is given once daily with an effective half-life of 25 hours," write the investigators in their June...
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Tirbanibulin FDA Approved for Actinic Keratosis

The FDA has now approved tirbanibulin (Klisyri®, Athenex) for treating actinic keratosis (AK) on the face or scalp topically. Actinic keratosis is a precancerous lesion that forms on skin that has been damaged by long-term, chronic exposure to ultraviolet rays from the sun and/or indoor tanning. As the second most common diagnosis made by dermatologists in the US, AK will develop into skin cancers 10%-15% of the time when left untreated. Approval was based on effective results shown in two pivot...
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Jaume Mora, MD, PhD: Naxitamab Approval for High-Risk Neuroblastoma in the Bone or Bone Marrow

Recently, the FDA approved naxitamab in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for patients with relapsed/refractory high-risk neuroblastoma in the bone or bone marrow. In this interview, Jaume Mora, MD, PhD, Scientific Director of Oncology and Hematology at Sant Joan de Déu Barcelona Children's Hospital and lead investigator of one of the trials on which the approval was based, speaks with i3 Health about the benefits of naxitamab for patients with relapsed/r...
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