FDA has approved ImmunityBio’s Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin for the treatment of patients with BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors.
Health Canada approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing-chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
The European Commission has approved a label extension for Astellas Pharma’s Xtandi (enzalutamide) as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer who are unsuitable for salvage-radiotherapy.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Bristol Myers Squibb's Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
FDA revised a draft guidance to answer questions that biologics companies may have when developing promotional communications for prescription biologics including reference products, biosimilars, and interchangeable biosimilars.
Sidney Kimmel Cancer Center at Jefferson Health can add the word “Comprehensive” to its name, becoming the 57th institution to earn this top-level designation from NCI.
Comprehensive cancer centers seek to reduce the burden of cancer through clinical care, research, education, and community engagement, including a commitment to diversity.
People of African ancestry (Black/African American) have some of the worst cancer incidence and greatest mortality, compared to white and other racial and ethnic populations in the U.S1-3. On average, Black persons are 1.5 times more likely to have cancer and >2X more likely to die from cancer compared to whites.4-6
Andrew Smith was named chair of St. Jude’s Diagnostic Imaging Department. He succeeds Beth McCarville, who was interim chair of the department since the death of Zoltan Patay, who held the position from 2017 to 2022.
NCI has renewed MUSC Hollings Cancer Center’s five-year Cancer Center Support Grant, with an overall rating of “outstanding.”
