- The author estimates that in 2016, there were approximately 12,300 incident cases of tumor lysis syndrome (TLS) worldwide among individuals with high-risk malignancies (acute myeloid leukemia, acute lymphocytic leukemia, and Burkitt’s lymphoma).
- The number of incident cases is forecasted to increase to 13,400 by 2025. Marketed drugs for TLS comprise xanthine oxidase inhibitors such as Aloprim (allopurinol) and Uloric (febuxostat), as well as a recombinant urate oxidase enzyme, Elitek (rasburicase).
- Uloric is the only drug in active clinical development in the US for TLS. It targets xanthine oxidase, and is administered orally. The distribution of clinical trials across Phase I-IV indicates that the majority of trials for TLS have been in the late phase of development, with around 67% in Phase III-IV and only 33% in Phase I-II.
- The US has a substantial lead in the number of TLS clinical trials globally. Clinical trial activity in the TLS space is dominated by completed trials. Sanofi has the highest number of completed clinical trials for TLS, with six in total.
- Sanofi has carried out the most clinical trials in the TLS space, with Menarini being the only other trial sponsor.
Prophylaxis and monitoring
Renal replacement therapy
Approvals by country
CLINICAL TRIAL LANDSCAPE
Sponsors by status
Sponsors by phase
List of Figures
Figure 1: Trends in incident cases of TLS in selected high-risk malignancies, 2016-25
Figure 2: Overview of pipeline drugs for TLS in the US
Figure 3: Pipeline drugs for TLS, by company
Figure 4: Pipeline drugs for TLS, by drug type
Figure 5: Pipeline drugs for TLS, by classifications
Figure 6: Clinical trials in TLS
Figure 7: Top 10 drugs for clinical trials in TLS
Figure 8: Top 10 companies for clinical trials in TLS
Figure 9: Trial locations in TLS
Figure 10: TLS trials status
Figure 11: TLS trials sponsors, by phase
List of Tables
Table 1: Incident cases of TLS in selected high-risk malignancies, 2016-25
Table 2: Incidence of acute myeloid leukemia, and proportion of individuals with TLS, 2016
Table 3: Incident cases of TLS in acute myeloid leukemia, 2016-25
Table 4: Incidence of acute lymphocytic leukemia, and proportion of individuals with TLS, 2016
Table 5: Incident cases of TLS in acute lymphocytic leukemia, 2016-25
Table 6: Incidence of Burkitt’s lymphoma, and proportion of individuals with TLS, 2016
Table 7: Incident cases of TLS in Burkitt’s lymphoma, 2016-25
Table 8: Marketed drugs for TLS
Table 9: Approvals by country for TLS
Table 10: Pipeline drugs for TLS in the US
Table 11: Parent patents in TLS
Table 12: Historical global sales, by drug ($m), 2012-16
Table 13: Forecasted global sales, by drug ($m), 2017-22