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Retsevmo ® ▼ (selpercatinib)
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What changes in haematology values were seen with Retsevmo® (selpercatinib)?
Most of the abnormal laboratory values and haematology events were grades 1 or 2 in severity. Three patients discontinued selpercatinib due to thrombocytopenia (n=2) and febrile neutropenia (n=1).
Haematology Abnormalities in LIBRETTO-001
Haematology Treatment-Emergent Adverse Events
Thrombocytopenia was the most common haematologic treatment-emergent adverse event (TEAE), occurring in 16% of patients.1 Haematology Treatment-Emergent Adverse Events in the LIBRETTO-001 Safety Population (N=796) presents haematologic TEAEs by frequency and severity.
Any Causality |
Related to Study Drug |
|||
TEAE, %a |
Any Grade |
Grade ≥3 |
Any Grade |
Grade ≥3 |
Thrombocytopeniab |
16 |
3 |
11 |
2 |
Lymphopenia |
14 |
5 |
7 |
2 |
Leukopenia |
13 |
2 |
8 |
1 |
Anemia |
12 |
3 |
4 |
1 |
Neutropenia |
11 |
3 |
8 |
2 |
Polycythemia |
1 |
0 |
<1 |
0 |
Thrombocytosis |
1 |
0 |
<1 |
0 |
TEAE = treatment-emergent adverse event.
aJune 2021 data cutoff.
bThrombocytopenia is a composite term that includes thrombocytopenia and platelet count decreased.
As of June 2021 data cutoff, serious adverse events (SAE) that occurred were thrombocytopenia (n=4) and 1 event each of anemia, neutropenia, and lymphopenia. Related SAEs were thrombocytopenia in 2 patients and lymphopenia in 1 patient.1
There was one case of febrile neutropenia reported. It was a grade 3 SAE that was considered not related to selpercatinib 1
Haematology Laboratory Abnormalities in LIBRETTO-001
The majority of haematologic abnormalities were grade 1 or 2 in severity.1 Haematology Laboratory Abnormalities LIBRETTO-001 (N=796) provides the abnormal chemistry values in LIBRETTO-001.
Chemistry, %a |
Nb |
Any Grade |
Grades 3-4 |
Lymphocyte count decreased |
765 |
52 |
20 |
WBC count decreased |
791 |
49 |
2 |
Platelets decreased |
791 |
38 |
3 |
Hemoglobin decreased |
791 |
28 |
4 |
Neutrophil count decreased |
771 |
25 |
3 |
Abbreviations: WBC = white blood cell.
aJune 2021 data cutoff.
bNumber of patients.
Dose Modifications Due to Haematology Abnormalities in LIBRETTO-001
Two patients permanently discontinued selpercatinib due to thrombocytopenia, and 1 patient discontinued to to febrile neutropenia.1 Dose Modifications Due to TEAEs in the LIBRETTO-001 Safety Population (N=796) presents dose modifications due to haematology abnormalities in LIBRETTO-001.
TEAE, n (%)a |
Dose Interrupted |
Dose Reduced |
Thrombocytopenia |
24 (3) |
12 (2) |
Neutropenia |
12 (2) |
6 (1) |
Anemia |
5 (1) |
1 (<1) |
Leukopenia |
5 (1) |
N/A |
Lymphopenia |
3 (<1) |
N/A |
Thrombocytosis |
1 (<1) |
N/A |
Abbreviations: N/A = not applicable; TEAE = treatment-emergent adverse event.
aJune 2021 data cutoff.
LIBRETTO-001 Study Overview and Haematology Criteria
The efficacy of selpercatinib was evaluated in a phase 1/2, multicenter, open-label, single-arm clinical trial in patients with advanced rearranged during transfection (RET) fusion-positive non-small cell lung cancer, RET-mutant medullary thyroid cancer, RET fusion-positive thyroid cancer, and RET fusion-positive tumors other than lung or thyroid: Study LIBRETTO-001 (NCT03157128).2-5
Criteria for trial participation included adequate haematologic status for at least 7 days prior to treatment defined as
- absolute neutrophil count ≥ 1.0 × 109/L not requiring growth factor support
- platelet count ≥ 75 × 109/L not requiring transfusion support, and
- haemoglobin ≥ 9 g/dL not requiring transfusion support or erythropoietin.1
Patients were not allowed to receive concomitant hematopoietic growth factors for prophylaxis in cycle 1.1
References
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Drilon 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
3Retsevmo [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
4Wirth 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
5Phase 1/2 study of LOXO-292 in participants with advanced solid tumors, RET fusion-positive solid tumors, and medullary thyroid cancer (LIBRETTO-001). ClinicalTrials.gov identifier: NCT03157128. Updated August 8, 2022. Accessed August 31, 2022. https://www.clinicaltrials.gov/ct2/show/NCT03157128
▼ 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: 14 April 2022