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Retsevmo ® ▼ (selpercatinib)
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Could hemorrhagic events occur with Retsevmo® ▼ (selpercatinib)?
In the LIBRETTO-001 trial, none of the 3 fatal hemorrhagic events were considered to be related to selpercatinib.
Serious including fatal hemorrhagic events can occur with selpercatinib. Permanently discontinue selpercatinib in patients with severe or life-threatening hemorrhage.1
Dosing Modifications for Hemorrhagic Events
Modification guidelines for hemorrhagic events are provided in Table 1.1
Table 1. Dose Management for Hemorrhagic Events1
Grade |
Dose Modification |
Grade 1 or 2 |
|
Grade 3 or 4 |
Selpercatinib and Hemorrhagic Events
Clinical Trial Experience
LIBRETTO-001 is a multicenter, open-label, phase 1/2 study of selpercatinib administered orally to patients with RET fusion-positive solid tumors, RET-mutant MTC, and other tumors with RET activation.1-4
Serious including fatal hemorrhagic events can occur with selpercatinib. Grade ≥3 hemorrhagic events occurred in 2% of patients treated with selpercatinib including 3 (0.4%) patients with fatal hemorrhagic events of
-
cerebral hemorrhage (1)
-
tracheostomy site hemorrhage (1), and
-
hemoptysis (1).1
Overall, 17% of the LIBRETTO-001 population experienced a grade ≤4 hemorrhagic event with 2% of the events being grades 3/4. Of the grades 3/4 events, there was one grade 4 event of hematemesis.1,5
Forty-one preferred terms were included in the hemorrhage analysis. The grade 1/2 events (%) that occurred in ≥1% of the population were
-
epistaxis (5)
-
hematuria (3)
-
contusion (2)
-
hemoptysis (2)
-
rectal hemorrhage (1), and
-
vaginal hemorrhage (1).5
Of the grade 1/2 events (%) that occurred in ≥1% of the population, those considered related to selpercatinib were
-
epistaxis (8)
-
contusion (2)
-
hematuria (3), and
-
vaginal hemorrhage.5
Grade ≥3 hemorrhagic events occurred in 2% of patients treated with selpercatinib including 3 (0.4%) patients with fatal hemorrhagic events, as seen in Table 2.1,5
Table 2. Grade ≥3 Hemorrhagic Events in the LIBRETTO-001 (N=746)5
|
Severity by Gradea |
||
Event, n (%)b |
Grade 3 |
Grade 4 |
Grade 5 |
Gastric hemorrhage |
1 (0.1) |
NA |
NA |
Abdominal wall hemorrhage |
1 (0.1) |
NA |
NA |
Anal hemorrhage |
1 (0.1) |
NA |
NA |
Contusion |
1 (0.1) |
NA |
NA |
Cerebral hemorrhage |
1 (0.1) |
NA |
1 (0.1) |
Diverticulum intestinal hemorrhagic |
1 (0.1) |
NA |
NA |
GI hemorrhage |
1 (0.1) |
NA |
NA |
Hematemesis |
N/A |
1 (0.1) |
NA |
Hemorrhage intracranial |
1 (0.1) |
NA |
NA |
Hemoptysis |
1 (0.1) |
NA |
1 (0.1) |
Intra-abdominal hemorrhage |
1 (0.1) |
NA |
NA |
Pelvic hematoma |
1 (0.1) |
NA |
NA |
Postprocedural hemorrhage |
N/A |
NA |
1 (0.1) |
Retroperitoneal hematoma |
1 (0.1) |
NA |
NA |
Subdural hemorrhage |
1 (0.1) |
NA |
NA |
Traumatic hematoma |
1 (0.1) |
NA |
NA |
Upper GI hemorrhage |
1 (0.1) |
NA |
NA |
Abbreviations: CTCAE = Common Terminology Criteria for Adverse Events; GI = gastrointestinal; NA = not applicable.
a Severity grade assignment based on CTCAE (v4.03): grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening/debilitating), and grade 5 (fatal).
b Data cut-off March 2020.
Of the grade 3/4 TEAEs that occurred in LIBRETTO-001, hemorrhage intracranial (1 patient) and retroperitoneal hematoma (1 patient) were considered related to selpercatinib.5
Serious Adverse Events
Of the reported hemorrhagic TEAEs, those considered serious and related were hemorrhage intracranial (2 patients) and retroperitoneal hematoma (1 patient).5
Fatal Hemorrhagic Events
The fatal hemorrhagic events reported in LIBRETTO-001 were
-
cerebral hemorrhage
-
hemoptysis, and
-
postprocedure hemorrhage.1
None of the fatal events were considered to be related to selpercatinib.5
Dosing Modification
Selpercatinib-related dose reductions occurred due to eye hemorrhage (1 patient) and hemorrhage intracranial (1 patient). One patient discontinued selpercatinib due to retroperitoneal hematoma considered related to study drug.5
1. Retsevmo [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2. Phase 1/2 study of LOXO-292 in patients with advanced solid tumors, RET fusion-positive solid tumors, and medullary thyroid cancer (LIBRETTO-001). ClinicalTrials.gov identifier: NCT03157128. Updated July 2, 2020. Accessed January 25, 2020. https://www.clinicaltrials.gov/ct2/show/NCT03157128
3. Wirth LJ, Sherman E, Robinson B, et al. Efficacy of selpercatinib in RET-altered thyroid cancers. N Engl J Med. 2020;383(9):825-835. https://dx.doi.org/10.1056/NEJMoa2005651
4. Drilon A, Oxnard GR, Tan DSW, et al. Efficacy of selpercatinib in RET fusion-positive non-small-cell lung cancer. N Engl J Med. 2020;383(9):813-824. https://dx.doi.org/10.1056/NEJMoa2005653
5. Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
MTC = medullary thyroid cancer
RET = rearranged during transfection
TEAE = treatment-emergent adverse event
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Date of Last Review: 08 January 2021
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