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...

In patients with locally advanced gastric cancer, perioperative chemotherapy consisting of TAS-118 (S-1 and leucovorin) plus oxaliplatin shows promise with a tolerable safety profile, according to safety and efficacy results of the APOLLO-11 feasibility study to be presented this week at the 2021 Gastrointestinal Cancers Symposium. While preoperative TAS-118 plus oxaliplatin followed by D2 gastrectomy has been shown to be feasible for patients with gastric cancer, the efficacy of this regimen in...

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...

Compared with those without cancer, older patients with breast cancer have a higher risk of developing cardiovascular disease, according to a study now published in the Journal of the National Comprehensive Cancer Network. "In older women diagnosed with breast cancer, there is now a greater likelihood of dying of diseases other than the cancer itself," write the investigators, led by first author Anthony Matthews, PhD, a postdoctoral researcher at the Karolinska Institute in Sweden. "Cardiovascu...

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...