Selpercatinib
Selpercatinib is a selective RET inhibitor approved for any tumour with a RET fusion, with a further label update in July 2026.
LIBRETTO-001 (NSCLC ORR ~84% treatment-naive), LIBRETTO-431 (first-line vs chemo-immunotherapy), LIBRETTO-531 (medullary thyroid vs cabozantinib/vandetanib). Tumour-agnostic RET-fusion approval 2022; July 2026 FDA action listed among that month's oncology approvals.
1.Oral drug is absorbed and reaches the tumour
- Route
- Oral
- Schedule
- 160 mg twice daily (≥50 kg); 120 mg BID (<50 kg); paediatric by BSA
- Dose modifications
- Reduce for hepatotoxicity, QTc, hypertension
- Monitoring
- LFTs every 2 weeks for 3 months; blood pressure; ECG; TSH; growth plates in children
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
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).
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- Lilly Cares Foundation
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- Appraised for
- RET fusion-positive advanced NSCLC after platinum chemotherapy
- Notes
- RET-altered thyroid cancer: TA711 (2021, CDF). Untreated NSCLC (LIBRETTO-431) appraised later.
- Cancer Drugs Fund
- Entered the Cancer Drugs Fund under a managed access agreement; check the current CDF list for whether it has since moved to routine commissioning.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
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.
- 8 May 2020ApprovalUS
Accelerated approval, RET-fusion NSCLC and thyroid cancer, RET-mutant MTC (LIBRETTO-001) source
- 21 Sept 2022ApprovalUS
RET-fusion solid tumours (tumour-agnostic, accelerated); full approval in NSCLC source
- 29 May 2024ApprovalUS
Paediatric ≥2 years source
- Jul 2026Label changeUS
Label update (July 2026 oncology approvals list) source
Approvals
| 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) |
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- TrialARROW (thyroid cohorts)
Shares Pralsetinib, RET, Thyroid cancer, Small-molecule kinase inhibitors.
- ProductVandetanib
Shares LIBRETTO-531, RET, Thyroid cancer, Small-molecule kinase inhibitors.
- TargetROS1
Shares Alexander Drilon, Koichi Goto, Sequence: targeted therapy before immunotherapy in driver-positive NSCLC, Receptor tyrosine kinase activation.
- PersonJustin F. Gainor
Shares Pralsetinib, RET, Non-small-cell lung cancer.
- ProductLarotrectinib
Shares Tumour-agnostic (tissue-agnostic) approval, Receptor tyrosine kinase activation, Thyroid cancer, Small-molecule kinase inhibitors.
- TargetNTRK
Shares Alexander Drilon, Receptor tyrosine kinase activation, Thyroid cancer, Rare and paediatric cancers without markets.
- IdeaAdopt tumour-agnostic cancer drug labels across regions by reliance, not re-review
Shares RET, Tumour-agnostic (tissue-agnostic) approval, Rare and paediatric cancers without markets.
- TrialSELECT
Shares RET, Thyroid cancer, Small-molecule kinase inhibitors.