The Pragmatica-Lung trial required many people to start to think differently about conducting phase III clinical trials—and it took a lot of advocacy to make the trial launch quickly, said Ellen Sigal, founder and chair of Friends of Cancer Research.
Martha Donoghue was named associate director of pediatric oncology and rare cancers in the FDA Oncology Center of Excellence.
FDA has approved Rezlidhia (olutasidenib) capsules for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation as detected by an FDA-approved test.
Genentech, a member of the Roche Group, voluntarily withdrew the U.S. indication of Tecentriq (atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
FDA has granted accelerated approval to Elahere for the treatment of adult patients with folate receptor alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
FDA has approved Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer with no EGFR, ALK, or ROS1 aberrations.
FDA has approved Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer with no sensitizing EGFR mutation or anaplastic lymphoma kinase genomic tumor aberrations.
FDA approved Adcetris (brentuximab vedotin) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients 2 years of age and older with previously untreated high risk classical Hodgkin lymphoma. This is the first pediatric approval for Adcetris.
FDA has been mulling over reliance on real-world evidence for about a decade, keeping it on the edges of the existing approval system that runs on data from conventional clinical trials.
FDA issued a revised draft guidance for industry, “Expanded Access to Investigational Drugs for Treatment Use Questions and Answers.”
