Retevmo (selpercatinib)
An approved treatment for RET Fusion Cancer, Medullary Thyroid Cancer and Familial Medullary Thyroid Carcinoma.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Selpercatinib wherever you encounter it, plus the key facts at a glance.
- Generic name
- Selpercatinib
- Brand name
- Retevmo
- Development code
- LOXO-292
- Drug class
- RET kinase inhibitor
- Manufacturer
- Eli Lilly and Company
- How it's taken
- Oral capsules or tablets, usually twice a day
A pill usually taken twice a day that blocks RET, a growth signal that a RET gene fusion or a RET mutation keeps switched on.
It is approved for adults with locally advanced or metastatic RET fusion-positive non-small cell lung cancer, and for adults and children 2 and older with advanced or metastatic medullary thyroid cancer with a RET mutation, advanced or metastatic RET fusion-positive thyroid cancer, and other locally advanced or metastatic RET fusion-positive solid tumors that have grown after earlier treatment or have no satisfactory alternative[1].
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Where Selpercatinib fits
Retevmo (selpercatinib) is a selective RET inhibitor approved for RET fusion-positive lung cancer, RET fusion-positive thyroid and other solid tumors, and RET-mutant medullary thyroid cancer, with all but the lung cancer use open to children 2 and older.
- Gavreto (pralsetinib) is the other selective RET inhibitor approved for RET fusion-positive lung and thyroid cancer[12].
- No trial has compared Retevmo and Gavreto directly.
- In medullary thyroid cancer, the LIBRETTO-531 trial compared Retevmo with a doctor's choice of cabozantinib or vandetanib in people who had not taken a kinase inhibitor, and progression-free survival was longer on Retevmo.
- In RET fusion-positive lung cancer, the LIBRETTO-431 trial compared Retevmo with platinum and pemetrexed chemotherapy plus pembrolizumab as a first treatment, and progression-free survival was longer on Retevmo, while overall survival results are not yet final.
- Anyone weighing Retevmo can ask their oncologist which test found the RET change and how its result fits the uses on the label.
How Selpercatinib works
RET is a gene that makes a growth-signaling protein. In a RET fusion, part of the RET gene joins another gene, such as KIF5B or CCDC6, and the new protein keeps the signal on. In medullary thyroid cancer, a change in the RET gene itself, such as M918T, does the same. Selpercatinib blocks wild-type RET and several mutated forms at very low concentrations.
It also blocks VEGFR1 and VEGFR3, and blocks FGFR1, 2 and 3 at higher concentrations that can still be reached in the body; in cell tests it blocked RET at about 60-fold lower concentrations than FGFR1 and 2[1]. Treatment is chosen only after a test of the tumor finds a RET fusion or, for medullary thyroid cancer, a RET mutation. The label lists FDA-approved tests at fda.gov/CompanionDiagnostics and says no FDA-approved blood (plasma) test for RET changes is available[1].
Side effects and safety
- Liver toxicity. Serious liver reactions in 4.6%; AST rose in 62% (grade 3 or 4 in 11%) and ALT in 58% (grade 3 or 4 in 13%).
- Lung inflammation (interstitial lung disease or pneumonitis). In 3% of patients, grade 3 or 4 in 0.3% and fatal in 0.2%; new or worse shortness of breath, cough or fever needs prompt checking.
- High blood pressure. In 43%, grade 3 in 20%; the label says not to start Retevmo while blood pressure is uncontrolled.
- QT prolongation. A QTcF over 500ms was measured in 8% and a rise of at least 60ms in 22%; risk is higher with CYP3A inhibitors and other QT-prolonging drugs.
- Bleeding. Grade 3 or worse bleeding in 4.3%, including 4 fatal events (0.5%).
- Allergic-type reactions (hypersensitivity). In 6%, grade 3 in 2%, with fever, rash and joint or muscle pain; Stevens-Johnson syndrome has been reported after approval.
- Tumor lysis syndrome. In 0.9% of people with medullary thyroid cancer and 0.3% with lung cancer; more likely with fast-growing or large tumors, kidney problems or dehydration.
- Wound healing. Retevmo is paused at least 7 days before elective surgery and for at least 2 weeks after major surgery.
- Underactive thyroid. In 15% of patients, all grade 1 or 2.
- Growth plates in children. A slipped hip growth plate (SCFE) occurred in 1 of 36 young patients in LIBRETTO-121, and in 1 teen among the 193 mostly adult patients in LIBRETTO-531.
- Pregnancy and breastfeeding. Can harm an unborn baby; the label advises effective contraception for women and for men with female partners during treatment and for 1 week after the last dose, and no breastfeeding for the same period.
- AST and ALT before starting, every 2 weeks for the first 3 months, then monthly
- Blood pressure after 1 week, then at least monthly
- ECG for the QT interval, electrolytes and TSH at the start and during treatment
- Thyroid function before and during treatment
- Growth plates in children whose growth plates are still open
- Breathing symptoms such as cough, shortness of breath or fever
Retevmo has no boxed warning and no contraindications[1]. The label warns about liver damage: serious liver reactions in 4.6% of patients, with AST rising in 62% and ALT in 58%. It also warns about high blood pressure in 43% (grade 3 in 20%), changes in the heart's electrical rhythm (a QTcF over 500ms in 8%), and lung inflammation in 3% (fatal in 0.2%).
Other label warnings cover serious bleeding (grade 3 or worse in 4.3%, fatal in 0.5%), allergic-type reactions in 6% including Stevens-Johnson syndrome, tumor lysis syndrome, slower wound healing, an underactive thyroid in 15%, and harm to an unborn baby[1]. In children and teens, the label reports a hip growth plate slipping (slipped capital femoral epiphysis) in 1 of 36 young patients in LIBRETTO-121, and in 1 teen among the 193 mostly adult patients in LIBRETTO-531, and says growth plates are monitored in children whose growth plates are still open[1].
Among 857 patients with solid tumors in LIBRETTO-001, nearly all adults, the most common side effects, in 25% or more, were musculoskeletal pain (59%), swelling (53%), diarrhea (52%), fatigue (49%), dry mouth (44%), high blood pressure (43%), belly pain (39%), rash (38%), nausea (36%), constipation (35%), cough (30%), headache (30%), vomiting (29%), shortness of breath (28%) and bleeding (26%)[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Selpercatinib
For adults and children 12 and older, the dose depends on weight: 120mg twice a day under 50kg, and 160mg twice a day at 50kg or more. For children 2 to under 12, the dose depends on body surface area, from 40mg 3 times a day for the smallest children to 160mg twice a day; the label does not recommend dosing below 0.33 square meters[1].
Retevmo comes as 40mg and 80mg capsules and as 40mg, 80mg, 120mg and 160mg tablets, swallowed whole and taken with or without food. For people who cannot swallow pills or who use a feeding tube, the label gives steps for dispersing only the 40mg tablets in water (or, by mouth, carrot puree)[1]. A missed dose is skipped unless the next dose is more than 6 hours away, and no extra dose is taken after vomiting.
The label says to avoid acid reducers (proton pump inhibitors, H2 blockers and antacids) and strong or moderate CYP3A inhibitors and inducers. When an acid reducer cannot be avoided, the label times the doses: Retevmo is taken with food alongside a proton pump inhibitor, 2 hours before or 10 hours after an H2 blocker, and 2 hours before or after an antacid[1].
Availability and cost
Only available as the brand-name product.
Help paying for Retevmo
With private insurance, the drugmaker's copay card can lower what you pay for Retevmo. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE, but charity funds often can. None of the 3 charity funds for the conditions it treats were open on October 26, 2026. Pick your insurance below to see which offers fit you.
- Copay help
Retevmo Savings Card: people with commercial drug insurance that covers Retevmo may pay as little as $0 a month (30 days), up to $10,600 per calendar year and up to 14 fills a year; for people in a copay maximizer plan, up to $25 a month and $350 a year. Not valid with Medicaid, Medicare, Medicare Part D, Medicare Advantage, Medigap, DoD, VA, TRICARE/CHAMPUS or any state prescription drug assistance program. US or Puerto Rico residents 18 and older; activation required. Lilly says the card expires and savings end on 12/31/2026.
For: private insurance · source - Insurance and case manager help
Lilly lists 1-800-LillyRx (1-800-545-5979) for general help, and the HCP page offers a sample appeals letter, a sample letter of medical necessity and a list of contracted specialty pharmacies.
The official page does not say who qualifies. Ask the program. · source
Good to know: Terms confirmed on retevmo.lilly.com/savings-support on November 12, 2026. People in alternate funding programs are not eligible. The HCP page says Lilly Support Services and the provider portal for Retevmo ended September 15, 2026. No free-drug terms are recorded: lillycares.com could not be read (403) and the Retevmo pages do not mention a free-drug program. Neither Retevmo page lists phone hours. Recheck in January 2027 for new card terms.
Charity funds
- From a charity · The Assistance FundThyroid Cancer fundWaitlist
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
Every program and charity fund for RET Fusion Cancer →
Every program and charity fund for Medullary Thyroid Cancer →
Every program and charity fund for Familial Medullary Thyroid Carcinoma →
Access and eligibility
Adults with locally advanced or metastatic non-small cell lung cancer with a RET gene fusion found by an FDA-approved test; adults and children 2 and older with advanced or metastatic medullary thyroid cancer with a RET mutation who need systemic treatment; adults and children 2 and older with advanced or metastatic RET fusion-positive thyroid cancer who need systemic treatment and whose cancer no longer responds to radioactive iodine, when radioactive iodine is appropriate; and adults and children 2 and older with other locally advanced or metastatic RET fusion-positive solid tumors that have grown on or after earlier treatment or have no satisfactory alternative.
Source: Retevmo Savings Card
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
LIBRETTO-001 (NCT03157128) was a single-arm trial. Among 247 adults with RET fusion-positive lung cancer treated before with platinum chemotherapy, 61% responded and the median response lasted 28.6 months; among 69 with no earlier treatment, 84% responded[1]. In RET-mutant medullary thyroid cancer, 76% of 55 patients treated before with cabozantinib or vandetanib responded, and 81% of 88 who had not taken either drug responded.
In RET fusion-positive thyroid cancer, 85% of 41 previously treated and 96% of 24 untreated patients responded. Among 75 patients with other RET fusion-positive tumors, mostly colorectal and pancreatic cancer, 47% responded, with a median response of 24.5 months[1]. Randomized trials compared Retevmo with other treatments head to head.
In LIBRETTO-531 (NCT04211337), 291 people with medullary thyroid cancer who had not had a kinase inhibitor got Retevmo or a doctor's choice of cabozantinib or vandetanib. The cancer was less likely to grow (hazard ratio 0.28): median progression-free survival was not reached on Retevmo against 16.8 months, and 69% responded against 39%[1].
In LIBRETTO-431 (NCT04194944), people with untreated RET fusion-positive lung cancer got Retevmo or platinum and pemetrexed chemotherapy, with or without pembrolizumab. Of 261 people randomized, 212 were slated for pembrolizumab if assigned to chemotherapy; in that group, median progression-free survival was 24.8 months against 11.2 months.
Overall survival was immature at the main analysis. In an updated descriptive analysis at 43% of the planned events, 31% of people on Retevmo and 25% on chemotherapy with pembrolizumab had died (hazard ratio 1.26, a difference that could be chance), and the label notes that 74% of control patients whose cancer grew went on to take Retevmo, which can affect this comparison[1].
LIBRETTO-121 (NCT03899792) studied children and young adults 2 to 20, and supports the pediatric uses[1]. LIBRETTO-432 (NCT04819100) tested Retevmo against placebo after surgery or radiation for early-stage RET fusion-positive lung cancer. That use is not on the label. In the 109 patients with stage II or IIIA disease, 92% were alive without the cancer returning or growing at 2 years, against 61% on placebo, according to the New England Journal of Medicine paper published May 31, 2026[9].
Development history
Selpercatinib was developed under the code LOXO-292[10]. The FDA first approved Retevmo capsules on May 8, 2020, for RET fusion-positive lung cancer, RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer, with the thyroid uses for people 12 and older[2][7][6]. On September 21, 2022, the FDA added an accelerated approval for adults with other RET fusion-positive solid tumors[4][2].
The lung cancer use now carries regular approval, as the current label shows[1]. Tablets were approved on April 10, 2024[3]. On May 29, 2024, the FDA extended the thyroid and solid tumor uses to children 2 and older under accelerated approval[5]. The FDA then granted traditional approval for RET fusion-positive thyroid cancer on June 12, 2024, for RET-mutant medullary thyroid cancer on September 27, 2024, and for other RET fusion-positive solid tumors on July 14, 2026[6][7][8].
The label updated in November 2025 added instructions for dispersing tablets for people who cannot swallow them[1].
Explore RET Fusion Cancer and Medullary Thyroid Cancer and Familial Medullary Thyroid Carcinoma trials
Other RET Fusion Cancer & Medullary Thyroid Cancer treatments
Common questions about Selpercatinib
▸What is Selpercatinib (Retevmo)?
A pill usually taken twice a day that blocks RET, a growth signal that a RET gene fusion or a RET mutation keeps switched on. It is approved for adults with locally advanced or metastatic RET fusion-positive non-small cell lung cancer, and for adults and children 2 and older with advanced or metastatic medullary thyroid cancer with a RET mutation, advanced or metastatic RET fusion-positive thyroid cancer, and other locally advanced or metastatic RET fusion-positive solid tumors that have grown after earlier treatment or have no satisfactory alternative[1].
▸How does Selpercatinib work?
RET is a gene that makes a growth-signaling protein. In a RET fusion, part of the RET gene joins another gene, such as KIF5B or CCDC6, and the new protein keeps the signal on. In medullary thyroid cancer, a change in the RET gene itself, such as M918T, does the same. Selpercatinib blocks wild-type RET and several mutated forms at very low concentrations. It also blocks VEGFR1 and VEGFR3, and blocks FGFR1, 2 and 3 at higher concentrations that can still be reached in the body; in cell tests it blocked RET at about 60-fold lower concentrations than FGFR1 and 2[1]. Treatment is chosen only after a test of the tumor finds a RET fusion or, for medullary thyroid cancer, a RET mutation. The label lists FDA-approved tests at fda.gov/CompanionDiagnostics and says no FDA-approved blood (plasma) test for RET changes is available[1].
▸What are the side effects of Selpercatinib?
Retevmo has no boxed warning and no contraindications[1]. The label warns about liver damage: serious liver reactions in 4.6% of patients, with AST rising in 62% and ALT in 58%. It also warns about high blood pressure in 43% (grade 3 in 20%), changes in the heart's electrical rhythm (a QTcF over 500ms in 8%), and lung inflammation in 3% (fatal in 0.2%). Other label warnings cover serious bleeding (grade 3 or worse in 4.3%, fatal in 0.5%), allergic-type reactions in 6% including Stevens-Johnson syndrome, tumor lysis syndrome, slower wound healing, an underactive thyroid in 15%, and harm to an unborn baby[1]. In children and teens, the label reports a hip growth plate slipping (slipped capital femoral epiphysis) in 1 of 36 young patients in LIBRETTO-121, and in 1 teen among the 193 mostly adult patients in LIBRETTO-531, and says growth plates are monitored in children whose growth plates are still open[1]. Among 857 patients with solid tumors in LIBRETTO-001, nearly all adults, the most common side effects, in 25% or more, were musculoskeletal pain (59%), swelling (53%), diarrhea (52%), fatigue (49%), dry mouth (44%), high blood pressure (43%), belly pain (39%), rash (38%), nausea (36%), constipation (35%), cough (30%), headache (30%), vomiting (29%), shortness of breath (28%) and bleeding (26%)[1].
▸How is Selpercatinib taken?
For adults and children 12 and older, the dose depends on weight: 120mg twice a day under 50kg, and 160mg twice a day at 50kg or more. For children 2 to under 12, the dose depends on body surface area, from 40mg 3 times a day for the smallest children to 160mg twice a day; the label does not recommend dosing below 0.33 square meters[1]. Retevmo comes as 40mg and 80mg capsules and as 40mg, 80mg, 120mg and 160mg tablets, swallowed whole and taken with or without food. For people who cannot swallow pills or who use a feeding tube, the label gives steps for dispersing only the 40mg tablets in water (or, by mouth, carrot puree)[1]. A missed dose is skipped unless the next dose is more than 6 hours away, and no extra dose is taken after vomiting. The label says to avoid acid reducers (proton pump inhibitors, H2 blockers and antacids) and strong or moderate CYP3A inhibitors and inducers. When an acid reducer cannot be avoided, the label times the doses: Retevmo is taken with food alongside a proton pump inhibitor, 2 hours before or 10 hours after an H2 blocker, and 2 hours before or after an antacid[1].
▸Is Selpercatinib FDA approved?
Yes, Selpercatinib (Retevmo) is FDA approved (2020) for the treatment of RET Fusion Cancer and Medullary Thyroid Cancer and Familial Medullary Thyroid Carcinoma.
▸Is Retevmo approved for children?
Yes, for children 2 and older with certain RET-driven cancers, but not for RET fusion lung cancer, which is approved for adults only[1].
Approved uses in children: medullary thyroid cancer with a RET mutation, RET fusion-positive thyroid cancer, and other RET fusion-positive solid tumors.
Dose: for ages 2 to under 12 it is set by body surface area; from age 12 it is set by weight.
Growth plates: the label calls for monitoring growth plates in children whose growth plates are still open, and reports a slipped hip growth plate in 1 of 36 young patients in LIBRETTO-121.
First approved for under-12s: May 29, 2024, now traditional approval for every pediatric use.
Source: Retevmo prescribing information, July 2026; FDA approval notices, 2024 and 2026.
▸Can Retevmo be taken with heartburn medicines like omeprazole or famotidine?
The label says to avoid acid reducers with Retevmo because they lower the amount of drug in the blood, and it gives timing rules when they cannot be avoided[1].
Proton pump inhibitors (such as omeprazole): Retevmo is taken with food.
H2 blockers (such as famotidine): Retevmo is taken 2 hours before or 10 hours after.
Antacids: Retevmo is taken 2 hours before or 2 hours after.
Worth asking: the oncologist or pharmacist can review every heartburn medicine, including over-the-counter ones.
Source: Retevmo prescribing information, July 2026, sections 2.4 and 7.1.
▸How does Retevmo compare with cabozantinib or vandetanib for medullary thyroid cancer?
In the head-to-head LIBRETTO-531 trial, the cancer stayed in check longer on Retevmo than on a doctor's choice of cabozantinib or vandetanib[1].
Who was in it: 291 adults and teens with progressive, advanced RET-mutant medullary thyroid cancer who had not taken a kinase inhibitor.
Progression-free survival: median not reached on Retevmo, 16.8 months on cabozantinib or vandetanib (hazard ratio 0.28).
Response: 69% against 39%.
Stopping for side effects: 4.7% against 27%.
Overall survival: still immature at the analysis the label reports.
Source: Retevmo prescribing information, July 2026, section 14.2.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Eli Lilly and Company via DailyMed · 2026-09-11. RETEVMO- selpercatinib capsule RETEVMO- selpercatinib tablet, coated. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7fa848ba-a59c-4144-9f52-64d090f4d828
- FDA. Retevmo approval history, capsules. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213246
- FDA. Retevmo approval history, tablets and capsules. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218160
- FDA · 2022-09-21. FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors. https://www.fda.gov/drugs/cancer-approvals/fda-approves-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive-solid-tumors
- FDA · 2024-05-29. FDA grants accelerated approval to selpercatinib for pediatric patients two years and older with RET-altered metastatic thyroid cancer or solid tumors. https://www.fda.gov/drugs/cancer-approvals/fda-grants-accelerated-approval-selpercatinib-pediatric-patients-two-years-and-older-ret-altered
- FDA · 2024-06-12. FDA approves selpercatinib for RET fusion-positive thyroid cancer. https://www.fda.gov/drugs/cancer-approvals/fda-approves-selpercatinib-ret-fusion-positive-thyroid-cancer
- FDA · 2024-09-27. FDA approves selpercatinib for medullary thyroid cancer with a RET mutation. https://www.fda.gov/drugs/cancer-approvals/fda-approves-selpercatinib-medullary-thyroid-cancer-ret-mutation
- FDA · 2026-07-14. FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors. https://www.fda.gov/drugs/cancer-approvals/fda-grants-traditional-approval-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive
- New England Journal of Medicine (Wu et al., PMID 42223087) · 2026-05-31. Selpercatinib in Early-Stage RET Fusion-Positive Non-Small-Cell Lung Cancer. https://pubmed.ncbi.nlm.nih.gov/42223087/
- ClinicalTrials.gov. A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001). https://clinicaltrials.gov/study/NCT03157128
- Eli Lilly and Company. Savings & Support: Savings Card & More | Retevmo® (selpercatinib). https://retevmo.lilly.com/savings-support
- Rigel Pharmaceuticals via DailyMed · 2025-12-30. GAVRETO- pralsetinib capsule. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=16edd46e-28b8-f06d-e063-6394a90ae31b