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Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid.
Algorri M, Acharya A, Bernstein J, Cauchon NS, Chen XH, Huynh-Ba K, Krantz C, Li T, Li Y, McLamore S, Roberts SW, Schwinke D, Shah R, Schirmer A, Strickland H, Tang K, Watson T. Algorri M, et al. Among authors: mclamore s. AAPS Open. 2022;8(1):19. doi: 10.1186/s41120-022-00066-1. Epub 2022 Dec 5. AAPS Open. 2022. PMID: 36530577 Free PMC article.
FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy.
Przepiorka D, Le RQ, Ionan A, Li RJ, Wang YH, Gudi R, Mitra S, Vallejo J, Okusanya OO, Ma L, Yang Y, Patel P, Mezaache D, Shah R, Banerjee A, McLamore S, Maung AN, Goldberg KB, Pazdur R, Theoret MR, De Claro RA. Przepiorka D, et al. Among authors: mclamore s. Clin Cancer Res. 2022 Jun 13;28(12):2488-2492. doi: 10.1158/1078-0432.CCR-21-4176. Clin Cancer Res. 2022. PMID: 35135839 Free PMC article.
FDA Approval Summary: Oral Azacitidine for Continued Treatment of Adults with Acute Myeloid Leukemia Unable to Complete Intensive Curative Therapy.
Jen EY, Wang X, Li M, Li H, Lee SL, Ni N, Przepiorka D, Vallejo J, Leong R, Ma L, Gehrke BJ, McLamore S, Theoret MR, de Claro RA. Jen EY, et al. Among authors: mclamore s. Clin Cancer Res. 2022 Jul 15;28(14):2989-2993. doi: 10.1158/1078-0432.CCR-21-4525. Clin Cancer Res. 2022. PMID: 35325108 Free PMC article. Clinical Trial.