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 investi...
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 ...
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...
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...
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...