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Selpercatinib is a selective RET inhibitor approved for any tumour with a RET fusion, with a further label update in July 2026.
Selpercatinib is a selective RET kinase inhibitor, designed to avoid the off-target VEGFR effects of older multikinase drugs, taken as 160 mg twice daily. LIBRETTO-001 showed a response rate of about 84% in treatment-naive RET-fusion NSCLC, LIBRETTO-431 beat chemo-immunotherapy first line, and LIBRETTO-531 beat cabozantinib or vandetanib in RET-mutant medullary thyroid cancer. It was approved in 2020 for RET-fusion NSCLC and thyroid cancer and RET-mutant MTC, gained a tumour-agnostic RET-fusion indication in 2022, and a July 2026 FDA action is listed among that month's oncology approvals. Hypertension, raised transaminases and QT prolongation are the main adverse events. Acquired resistance through RET solvent-front mutations and bypass pathways is the current limit. For a newcomer: a pill that works wherever a RET fusion drives the cancer, regardless of organ.
Highly selective RET TKI. Connects to RET.
1.Oral drug is absorbed and reaches the tumour
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. RET fusion or mutation by an approved test.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA742 · NHS England Cancer Drugs Fund list · SMC advice: selpercatinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2019-01-07 | Loxo Oncology to Eli Lilly (incl. Loxo) LOXO-292 (selpercatinib, Retevmo) and LOXO-305 (pirtobrutinib, Jaypirca) | Acquisition | not disclosed | $8.0bn | source |
Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy *
Accelerated approval, RET-fusion NSCLC and thyroid cancer, RET-mutant MTC (LIBRETTO-001) source
Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) *
Accelerated approval on a surrogate endpoint, with a confirmatory trial required. source
Adult patients with metastatic RET fusion-positive Non-Small Cell Lung Cancer (NSCLC)
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options *
RET-fusion solid tumours (tumour-agnostic, accelerated); full approval in NSCLC source
Adult patients with metastatic RET fusion-positive Non-Small Cell Lung Cancer (NSCLC)
Confirmed: the accelerated approval of 2020 converted to traditional approval 2.4 years after it was granted.
Formulation: Adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Formulation: Adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Formulation: Adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Paediatric ≥2 years source
Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) *
Confirmed: the accelerated approval of 2020 converted to traditional approval 4.1 years after it was granted. source
Formulation: Adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)
Confirmed: the accelerated approval of 2024 converted to traditional approval 0.2 years after it was granted.
Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy *
Confirmed: the accelerated approval of 2020 converted to traditional approval 4.4 years after it was granted.
Formulation: Adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy
Confirmed: the accelerated approval of 2024 converted to traditional approval 0.5 years after it was granted.
Adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options *
Traditional approval, locally advanced or metastatic RET fusion-positive solid tumours source
Formulation: Adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options
Confirmed: the accelerated approval of 2024 converted to traditional approval 2.3 years after it was granted.
| Region | Year | Indication |
|---|---|---|
| US | 2020 | RET-fusion NSCLC and thyroid; RET-mutant MTC |
| US | 2022 | RET-fusion solid tumours (tumour-agnostic) |
| US | 2026 | Label update (July 2026) |
| EU | 2021 | EU brand Retsevmo |
| England (NICE) | 2023 | Untreated RET fusion-positive advanced non-small-cell lung cancer · TA911, published 26 July 2023, recommends selpercatinib with managed access only, under a managed access agreement. |
| England (NICE) | 2025 | Previously treated RET fusion-positive advanced non-small-cell lung cancer not previously treated with a RET inhibitor · TA1042, published 19 February 2025, routine commissioning subject to the commercial arrangement. |
| Adverse event |
|---|
| Oedema |
| Diarrhoea |
| Fatigue |
| Dry mouth |
| Hypertension |
| AST/ALT increased |
| QT prolongation |
| Hypersensitivity |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part D (oral); commercial plans per formulary, often with prior authorisation | not disclosed | lillycares.com |
| United Kingdom | NICE: recommended for RET-fusion NSCLC and thyroid cancers (TA911, TA742, TA760) | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Selpercatinib is the established first-line treatment for RET fusion-positive lung cancer, and the trial adds to evidence that targeted therapy should precede chemo-immunotherapy in driver-positive disease.
Selpercatinib is the first-line standard for advanced RET-mutant medullary thyroid cancer; RET testing at diagnosis is essential.
RET fusion testing is standard in lung adenocarcinoma and selpercatinib the preferred first-line RET inhibitor, confirmed against chemo-immunotherapy in LIBRETTO-431.
Query for this drug: (TITLE:"Selpercatinib" OR ABSTRACT:"Selpercatinib" OR TITLE:"Retevmo" OR ABSTRACT:"Retevmo") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Selpercatinib, not a curated reading list.
Shares LIBRETTO-531, Multiple endocrine neoplasia type 2 (MEN2A and MEN2B), Thyroglobulin, calcitonin and CEA in thyroid cancer follow-up, Thyroid cancer (KEGG map).
Shares A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRET, LIBRETTO-431, Pralsetinib, RET fusion-positive non-small-cell lung cancer.
Shares Thyroid cancer (KEGG map), RACE for Children Act, Papillary thyroid cancer, NCI-COG Pediatric MATCH (APEC1621).
Shares Alexander Drilon, Thyroid cancer (KEGG map), Tumour-agnostic (tissue-agnostic) approval, Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall.
Shares Thyroid cancer (KEGG map), Lung cancer drugs in England: what NICE has recommended, Papillary thyroid cancer, Tumour-agnostic (tissue-agnostic) approval.
Shares Koichi Goto, Sequence: targeted therapy before immunotherapy in driver-positive NSCLC, Alexander Drilon, Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall.
Shares LIBRETTO-531: selpercatinib versus cabozantinib or vandetanib in advanced RET-mutant medullary thyroid cancer, Medullary thyroid cancer, Thyroid cancer.
Shares Alexander Drilon, RET fusion-positive non-small-cell lung cancer, Non-small cell lung cancer (KEGG map), Tumour-agnostic (tissue-agnostic) approval.