Haematologic adverse events, including anaemia, neutropenia, thrombocytopenia, and leukopenia, have been reported in patients treated with selpercatinib. Depending on the severity (grade), dose modifications or treatment interruptions may be required. General guidance on the management of adverse events can be found in Section 4.2 of the Summary of Product Characteristics (SmPC).

Section 4.8 of the SmPC provides further details regarding the frequency of these haematologic events.

For complete information, please consult the Retsevmo Summary of Product Characteristics, particularly:

• Section 4.2: Posology and method of administration
• Section 4.8: Undesirable effects

Below is additional data from clinical trials, including information on incidence, severity, and management of haematologic events. A full description of the clinical studies referenced is available in Section 5.1 of the SmPC.

Few dose interruptions or reductions occurred across selpercatinib studies due to thrombocytopenia, neutropenia, anemia, leukopenia, lymphopenia, or thrombocytosis.1 

In LIBRETTO-001, 2 patients permanently discontinued selpercatinib due to thrombocytopenia, and 1 patient discontinued due to febrile neutropenia.1 

In LIBRETTO-431 and LIBRETTO-531, no patients discontinued due to thrombocytopenia, neutropenia, anemia, leukopenia, lymphopenia, or thrombocytosis.1  

Criteria for trial participation included adequate hematologic status for at least 7 days before 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
• hemoglobin ≥ 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

LIBRETTO-001 is a multicenter, open-label, phase 1/2 study of selpercatinib administered orally to patients with rearranged during transfection (RET) fusion-positive solid tumors, RET-mutant medullary thyroid cancer, and other tumors with RET activation (NCT03157128).2-4

LIBRETTO-431 is a global, open-label, randomized, phase 3 trial comparing selpercatinib to platinum-based chemotherapy and pemetrexed with or without pembrolizumab as initial treatment in patients with locally advanced or metastatic RET fusion-positive nonsquamous non-small cell lung cancer (NCT04194944).5 

LIBRETTO-531 is a multicenter, randomized, open-label, phase 3 trial comparing selpercatinib to physician's choice of cabozantinib or vandetanib in patients with metastatic, advanced, kinase inhibitor naïve, RET-mutant MTC (NCT04211337).6-8

Links to references and third-party websites are provided solely for your convenience and to facilitate easy access to the sources cited.

▼ 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.