Many oral oncolytics inhibit rapidly dividing cells and are teratogenic. However, only a few agents are restricted under a Risk Evaluation and Mitigation Strategies (REMS) program due to embryo-fetal toxicity. The benefit of a REMS program for only select oral oncolytics is unclear.
SheikhH. FDA Risk Evaluation and Mitigation Strategies (REMS): Description and effect on generic drug development, https://www.congress.gov/crs-product/R44810 (accessed 29 June 2025).
3.
FrameJN, et al.Assessment of risk evaluation and mitigation strategies in oncology: summary of the oncology risk evaluation and mitigation strategies workshop.J Oncol Pract2013; 9: e24–e39.
4.
ChapmanJ, et al.Evaluating REMS burden: a comparative time analysis of 3 channels for REMS stakeholders to perform mandatory REMS tasks.Ther Innov Regul Sci2020; 54: 318–323.
U.S. Food and Drug Administration. Revlimid (lenalidomide) DRUGS@FDA. Updated March 24, (2023, accessed 29 June 2025).
8.
BadouxXCKeatingMJWenS, et al.Phase II study of lenalidomide and rituximab as salvage therapy for patients with relapsed or refractory chronic lymphocytic leukemia. J Clin Oncol2013; 31: 584–591.
9.
WiernikPHLossosISTuscanoJM, et al.Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma. J Clin Oncol2008; 26: 4952–4957.
10.
LeonardJPTrnenyMIzutsuK, et al.AUGMENT: a phase III study of lenalidomide plus rituximab versus placebo plus rituximab in relapsed or refractory indolent lymphoma. J Clin Oncol2019; 37: 1188–1199.
11.
U.S. Food and Drug Administration. Pomalyst (pomalidomide) DRUGS@FDA. Updated December 3, 2020, (accessed 2 July 2025).
12.
U.S. Food and Drug Administration. Thalomid (thalidomide) DRUGS@FDA. Updated February 25, 2021, (accessed 2 July 2025).
13.
SEER*Explorer: An interactive website for SEER cancer statistics [Internet]. Surveillance Research Program, National Cancer Institute; November 2024. [cited 2025 June 19]https://seer.cancer.gov/statistics-network/explorer/.
14.
HiattKM, et al.Classic Kaposi Sarcoma in the United States over the last two decades: a clinicopathologic and molecular study of 438 non-HIV-related Kaposi Sarcoma patients with comparison to HIV-related Kaposi Sarcoma.Mod Pathol2008; 21: 572–582.
15.
SekeresMATaylorJ. Diagnosis and treatment of myelodysplastic syndromes: a review.JAMA2022; 328: 872–880.
16.
SEER*Explorer: An interactive website for SEER cancer statistics [Internet]. Surveillance Research Program, National Cancer Institute; November 2024. [cited 2025 Aug 15]. Available from: https://seer.cancer.gov/statistics-network/explorer/.
17.
SEER*Explorer: An interactive website for SEER cancer statistics [Internet]. Surveillance Research Program, National Cancer Institute; November 2024. [cited 2025 Aug 15]. Available from: https://seer.cancer.gov/statistics-network/explorer/.
18.
ZhouY, et al.Incidence trends of mantle cell lymphoma in the United States between 1992 and 2004.Cancer: Interdiscipl Int J Am Cancer Soc2008; 113: 791–798.
19.
U.S. Food and Drug Administration. Caprelsa (Vandetanib) REMS@FDA. Updated January 5, 2024, (accessed 29 June 2025).
20.
U.S. Food and Drug Administration. Copiktra (duvelisib) REMS@FDA. Updated February 2, 2022, (accessed 29 June 2025).
21.
U.S. Food and Drug Administration. Turalio (Pexidartinib) REMS@FDA. Updated April 17. 2023, (accessed 29 June 2025).
22.
U.S. Food and Drug Administration. Vanflyta (quizartinib) REMS@FDA. Updated July 20, 2025, (accessed 29 June 2025).
23.
U.S. Food and Drug Administration. Revlimid (lenalidomide) REMS@FDA. Updated March 24, 2023, (accessed 29 June 2025).
24.
U.S. Food and Drug Administration. Pomalyst (pomalidomide) REMS@FDA. Updated October 30, 2020, (accessed 29 June 2025).
25.
U.S. Food and Drug Administration. Thalomid (thalidomide) REMS@FDA. Updated April 27, 2023, (accessed 29 June 2025).
26.
PaiJSPatelRAlgazeS, et al.Improving delays in obtaining lenalidomide at a large safety net hospital. Blood2021; 138: 1925.
27.
GasoyanHAnwerFKovachJD, et al.Disparities in time to first prescription fill for lenalidomide in patients with newly diagnosed multiple myeloma. Blood2024; 144: 5032–5032.
28.
CastanedaCMintonNMezoM, et al.False-positive pregnancy tests in females of reproductive potential receiving lenalidomide in the United States. Leukemia Lymphoma/Leukemia and Lymphoma2017; 59: 1025–1026.
29.
ParchinskiKUrquhart-FosterKPurserSA, et al.Disrupted care for multiple myeloma in an amenorrheic woman due to a false-positive pregnancy test: a case report. Curr Problems Cancer: Case Rep2024; 15: 100316.