Selpercatinib

iStock, Iryna Olkhova Practice-changing data in lung cancer, prostate cancer and more were on display over the weekend at the American Society of Clinical Oncology annual meeting in Chicago. Plus, early readouts on assets that could reshape the cancer landscape. The American Society of Clinical Oncology (ASCO) conference was in full swing in Chicago this weekend, with researchers from around the world showcasing paradigm-shifting results and the next generation of cancer therapeutics. Revolution Medicines’ groundbreaking pancreatic cancer candidate daraxonrasib and Chinese biopharma Akeso and partner Summit Therapeutics’ PD-1/VEGF inhibitor ivonescimab grabbed the most attention. But others, including Bristol Myers Squibb and BioNTech, Johnson & Johnson and Gilead Sciences posted compelling and potentially practice-changing data in lung, prostate and ovarian cancer. Here are some readouts that caught our attention. BioNTech and BMS score in the bispecific battle In the race of the PD-1/VEGF bispecific antibodies, BioNTech and BMS revealed Phase 2 data for their inhibitor pumitamig from the ROSETTA Lung-02 trial . The results included data from 40 patients with previously untreated advanced non-small cell lung cancer (NSCLC) treated with pumitamig plus chemotherapy in a global population. At nine months, the combination showed a confirmed objective response rate of 57.1% in patients with non-squamous NSCLC and 68.4% in patients with squamous NSCLC, and a disease control rate of 100%. Grade 3 treatment-related adverse events (TRAEs) thought to be related to pumitamig occurred in 23.3% of patients, with treatment discontinuation at 9.3%. “We see this as comparable to ivonescimab,” Truist Securities wrote in a note on Sunday. The pivotal Phase 3 ROSETTA Lung-02 trial is actively enrolling, BioNTech and BMS said in their press release s, along with two other Phase 3 trials in NSCLC. Pumitamig is also advancing in small-cell lung, triple-negative breast, colorectal and gastric cancers. J&J’s practice-changing shift in prostate cancer Johnson & Johnson’s Erleada before and after surgery significantly improved outcomes for patients with high-risk localized prostate cancer, according to the Phase 3 PROTEUS readout. The results could set a new standard of care in a setting where nearly half of patients who undergo curative surgery experience relapse. The trial enrolled some 2,100 patients to test frontline Erleada plus androgen-deprivation therapy (ADT) versus ADT plus placebo, with patients getting the treatment six months before and after radical prostatectomy. At about five years, the combination reduced the risk of developing metastasis or death by 20%, and five-year metastasis-free survival increased from 73.5% in the placebo group to 78.2% for patients who took Erleada. Nearly 9% of patients had a pathological complete response, compared to 1% of patients in the control arm. But while Erleada clearly improves outcomes, the drug has not yet been directly compared to other treatment options including upfront surgery, William K. Oh, director of precision medicine for Yale Cancer Center and an ASCO expert in genitourinary medicine, said in a press release . Incyte’s Monjuvi in first-line diffuse large B cell lymphoma Incyte could shift the standard of first-line (1L) care in diffuse large B cell lymphoma (DLBCL), where a chemotherapy regimen called R-CHOP reigned for decades. The Phase 3 frontMind trial put Incyte’s anti-CD19 monoclonal antibody Monjuvi/Minjuvi plus lenalidomide plus R-CHOP up against R-CHOP alone. The combo reduced the risk of disease or death by 25% in previously untreated high-intermediate or high-risk DLBCL patients, and 67.3% patients on the combo were alive and progression-free at three years, compared to 60.7% in the control arm. “We anticipate likely approval in 1L DLBCL early 2027 at the latest and note a nearly doubled market opportunity from [relapsed or refractory] DLBCL alone,” Trust Securities wrote in its Sunday note. Such an approval would set up competition with Roche’s antibody-drug conjugate Polivy, which the FDA approved in the same setting in 2023. Trust Securities noted that the pair appear to have comparable efficacy. FDA FDA Greenlights Roche’s Polivy in First-Line DLBCL Polivy is approved for front-line DLBCL as part of a combination regimen including Rituxan, cyclophosphamide, doxorubicin and prednisone. April 20, 2023 · 3 min read · Tristan Manalac Read more A solid bet by Gilead Meanwhile, a readout of Phase 1 data for the antibody-drug conjugate (ADC) TUB-040 came with good news for Gilead. The dose-escalation trial, called NAPISTAR 1-01 , evaluated dose levels of 1.67 mg/kg and 3.3 mg/kg for patients with platinum-resistant ovarian cancer. Among 46 patients, some 60.9% of them saw their tumors shrink, including 57% with a partial response and 4% with a complete response. The ADC targets NaPi2b, a cell-surface protein overexpressed in serious ovarian cancers (PROC) and NSCLC. It appeared to be well tolerated. “NAPISTAR 1-01 data of TUB-040 (NaPi2b ADC) in PROC appear consistent with the abstract, with promising efficacy and a manageable safety profile,” Leerink Partners wrote in a Monday morning note. TUB-040 is the lead asset from German biotech Tubulis, which Gilead snatched up earlier this year for $3.15 billion in cash and up to $1.85 billion in potential milestone payments. The acquisition closed a little over a week ago. Mergers & acquisitions Gilead Swallows Another Partner, Paying up to $5B for ADC Specialist Tubulis The acquisition of Tubulis GmbH—Gilead Sciences’ latest of the year after buying Arcellx and Ouro Medicines—brings into the fold a novel ovarian cancer candidate that has demonstrated promising mid-stage data. April 7, 2026 · 2 min read · Heather McKenzie Read more Eli Lilly present ‘extraordinary’ data in RET fusion-positive lung cancer Along with J&J’s PROTEUS readout, Eli Lilly scored a spot in the plenary on Sunday—with good reason. Its RET inhibitor Retevmo led to a significant 83% reduction in the risk of disease or death in the adjuvant setting for people with early-stage, RET fusion–positive NSCLC. The Phase 3 LIBRETTO-432 trial consisted of 151 previously treated patients with early-stage, RET-positive NSCLC, who were given either Retevmo or placebo for up to three years after their main treatment. At two years, the event-free survival (EFS) rate was 91.5% for patients taking Retevmo, versus 61.1% for placebo. The trial was the first to evaluate a RET kinase inhibitor as adjuvant therapy in early-stage, RET-altered NSCLC. “Already the RET standard of care, Retevmo’s adjuvant study showed striking curves; the Retevmo arm only had two events,” Leerink Partners wrote to investors Monday morning. Jake Van Naarden, Lilly’s president of Oncology and head of Corporate Business Development, “sees the results as helping to drive broader testing paradigms in early-stage lung, where EGFR and ALK are more commonly tested today,” the analysts added.

Phase 3 LIBRETTO-432 results establish RET fusions alongside EGFR mutations and ALK fusions as biomarkers in early-stage lung cancer that are associated with dramatic treatment outcomes, underscoring the importance of comprehensive biomarker testing across all stages of disease These data will be published in the New England Journal of Medicine and simultaneously presented during the Plenary Session at the 2026 ASCO Annual Meeting INDIANAPOLIS, May 31, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced results from the Phase 3 LIBRETTO-432 clinical trial of Retevmo (selpercatinib) as adjuvant therapy versus placebo in patients with early-stage (IB-IIIA) rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in investigator-assessed event-free survival (EFS) with selpercatinib reducing the risk of disease recurrence or death by 83% versus placebo in the primary analysis population. These data will be simultaneously published in the New England Journal of Medicine and presented during the Plenary Session at the 2026 ASCO Annual Meeting taking place in Chicago, Illinois, as well as featured in the meeting's press program. "Patients with early-stage RET fusion-positive lung cancer face high recurrence risk, yet unlike those with EGFR or ALK alterations, have lacked a proven targeted treatment option," said Jonathan Goldman, M.D., Professor of Medicine and Director of Clinical Trials at University of California, Los Angeles. "These LIBRETTO-432 results provide strong evidence that treating with selpercatinib after surgery or radiation can significantly lower that risk. The magnitude of benefit seen from adjuvant treatment with selpercatinib reinforces that comprehensive genomic testing at diagnosis is essential for all people with lung cancer and could lead to changes in clinical practice for treating early-stage RET-positive disease." LIBRETTO-432 is the first and only randomized Phase 3 study to evaluate the safety and efficacy of a selective RET kinase inhibitor as adjuvant therapy in this population. The trial enrolled 151 patients who were randomized 1:1 to receive selpercatinib 160mg twice daily or placebo for up to three years following completion of definitive radiotherapy or surgery with curative intent with or without adjuvant chemotherapy. At a median follow-up of 24 months, investigator-assessed EFS in the primary analysis population (patients with stage II-IIIA disease, n=109) was significantly improved with selpercatinib compared to placebo (HR: 0.17 [95% CI, 0.06 to 0.51]; p<0.001). The EFS rate at 24 months was 92% [95% CI, 75.4 to 97.2] for selpercatinib compared to 61% [95% CI, 44.2 to 74.3] for placebo. The median EFS was not reached for selpercatinib versus 31.8 months for placebo. In the overall study population (patients with stage IB-IIIA disease, n=151), EFS was consistent, also favoring selpercatinib (HR: 0.17 [95% CI, 0.06 to 0.49]; p<0.001). The EFS rate at 24 months was 94% [95% CI, 81.5 to 98.0] in the selpercatinib group and 70% [95% CI, 55.5 to 80.1] in the placebo group. Results were consistent across blinded independent central review and key subgroups in both the primary analysis set and in the overall study population. Overall survival results trended in favor of selpercatinib, but were immature at the time of this analysis with few events observed. The overall safety profile of selpercatinib in LIBRETTO-432 was generally consistent with previously reported trials in the selpercatinib development program. The most common Grade 3 or higher adverse events (AEs) were increased alanine aminotransferase (ALT) (17% in the selpercatinib group versus 1% in the placebo group) and increased aspartate aminotransferase (AST) (19% in the selpercatinib group versus 3% in the placebo group), but were manageable with dose-modification. "Selpercatinib has changed the treatment paradigm for patients with advanced RET-positive lung cancer, and now the substantial reduction in the risk of recurrence or death seen in LIBRETTO-432 highlights the potential for it to also become a new standard of care in the adjuvant setting for patients with early-stage RET-positive NSCLC," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "These compelling results highlight the importance of bringing our effective medicines to patients early in their disease course when their impact can be greatest, and bring further urgency to the need for comprehensive biomarker testing for all lung cancers at diagnosis to enable effective therapy against EGFR, ALK and RET and for the development of medicines targeting emerging new biomarkers." Lilly plans to submit results from LIBRETTO-432 to global health authorities. For more information on the LIBRETTO Phase 3 clinical trial program, please visit clinicaltrials.gov. About LIBRETTO-432 LIBRETTO-432 is a Phase 3, global, multicenter, randomized, double-blind, controlled clinical trial of selpercatinib versus placebo in patients with RET fusion-positive NSCLC following completion of definitive radiotherapy or surgery with curative intent, and other adjuvant therapy, if indicated. The trial enrolled 151 patients who were randomized 1:1 to receive either selpercatinib or placebo as adjuvant therapy for RET fusion-positive NSCLC. The primary endpoint is EFS as assessed by investigator in the primary analysis population, which was comprised of patients with stage II-IIIA RET fusion-positive NSCLC. Secondary endpoints include EFS as assessed by investigator in the overall population, overall survival (OS), EFS as assessed by blinded independent central review (BICR), time to distant disease recurrence in the central nervous system (CNS) as assessed by investigator and BICR, progression-free survival on the next line of treatment (PFS2), positive predictive value (PPV) of RET tests from investigator-identified laboratories with respect to the Lilly-designated RET test, safety and tolerability. About Retevmo Retevmo (selpercatinib, formerly known as LOXO-292) (pronounced reh-TEHV-moh) is a highly selective and potent RET kinase inhibitor with central nervous system (CNS) activity. Retevmo may affect both tumor cells and healthy cells, which can result in side effects. RET-driver alterations are predominantly mutually exclusive from other oncogenic drivers. Retevmo is a U.S. FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or ≥50 kg, respectively), taken twice daily until disease progression or unacceptable toxicity.1 INDICATIONS FOR RETEVMO (selpercatinib) RETEVMO is a kinase inhibitor indicated for the treatment of: Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test IMPORTANT SAFETY INFORMATION FOR RETEVMO (selpercatinib) Hepatotoxicity: Serious hepatic adverse reactions occurred in 3% of patients treated with Retevmo. Increased aspartate aminotransferase (AST) occurred in 59% of patients, including Grade 3 or 4 events in 11% and increased alanine aminotransferase (ALT) occurred in 55% of patients, including Grade 3 or 4 events in 12%. Monitor ALT and AST prior to initiating Retevmo, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose, or permanently discontinue Retevmo based on severity. Severe, life-threatening, and fatal interstitial lung disease (ILD)/pneumonitis can occur in patients treated with Retevmo. ILD/pneumonitis occurred in 1.8% of patients who received Retevmo, including 0.3% with Grade 3 or 4 events, and 0.3% with fatal reactions. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold Retevmo and promptly investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Withhold, reduce dose, or permanently discontinue Retevmo based on severity of confirmed ILD. Hypertension occurred in 41% of patients, including Grade 3 hypertension in 20% and Grade 4 in one (0.1%) patient. Overall, 6.3% had their dose interrupted and 1.3% had their dose reduced for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. Do not initiate Retevmo in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating Retevmo. Monitor blood pressure after 1 week, at least monthly thereafter, and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue Retevmo based on severity. Retevmo can cause concentration-dependent QT interval prolongation. An increase in QTcF interval to >500 ms was measured in 7% of patients and an increase in the QTcF interval of at least 60 ms over baseline was measured in 20% of patients. Retevmo has not been studied in patients with clinically significant active cardiovascular disease or recent myocardial infarction. Monitor patients who are at significant risk of developing QTc prolongation, including patients with known long QT syndromes, clinically significant bradyarrhythmias, and severe or uncontrolled heart failure. Assess QT interval, electrolytes, and thyroid-stimulating hormone (TSH) at baseline and periodically during treatment, adjusting frequency based upon risk factors including diarrhea. Correct hypokalemia, hypomagnesemia, and hypocalcemia prior to initiating Retevmo and during treatment. Monitor the QT interval more frequently when Retevmo is concomitantly administered with strong and moderate CYP3A inhibitors or drugs known to prolong QTc interval. Withhold and dose reduce or permanently discontinue Retevmo based on the severity. Serious, including fatal, hemorrhagic events can occur with Retevmo. Grade ≥3 hemorrhagic events occurred in 3.1% of patients treated with Retevmo including 4 (0.5%) patients with fatal hemorrhagic events, including cerebral hemorrhage (n=2), tracheostomy site hemorrhage (n=1), and hemoptysis (n=1). Permanently discontinue Retevmo in patients with severe or life-threatening hemorrhage. Retevmo can cause hypersensitivity, including severe skin reactions such as Stevens-Johnson Syndrome. All grade hypersensitivity occurred in 6% of patients receiving Retevmo, including Grade 3 in 1.9%. The median time to onset was 1.9 weeks (range: 5 days to 2 years). Signs and symptoms of hypersensitivity included fever, rash and arthralgias or myalgias with concurrent decreased platelets or transaminitis. Stevens-Johnson Syndrome has been observed in the post-marketing setting. Discontinue Retevmo in patients with Stevens-Johnson Syndrome. If hypersensitivity occurs, withhold Retevmo and begin corticosteroids at a dose of 1 mg/kg prednisone (or equivalent). Upon resolution of the event, resume Retevmo at a reduced dose and increase the dose of Retevmo by 1 dose level each week as tolerated until reaching the dose taken prior to onset of hypersensitivity. Continue steroids until patient reaches target dose and then taper. Permanently discontinue Retevmo for recurrent hypersensitivity. Tumor lysis syndrome (TLS) occurred in 0.6% of patients with medullary thyroid carcinoma receiving Retevmo. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated. Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, Retevmo has the potential to adversely affect wound healing. Withhold Retevmo for at least 7 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of Retevmo after resolution of wound healing complications has not been established. Retevmo can cause hypothyroidism. Hypothyroidism occurred in 13% of patients treated with Retevmo; all reactions were Grade 1 or 2. Hypothyroidism occurred in 13% of patients (50/373) with thyroid cancer and 13% of patients (53/423) with other solid tumors including NSCLC. Monitor thyroid function before treatment with Retevmo and periodically during treatment. Treat with thyroid hormone replacement as clinically indicated. Withhold Retevmo until clinically stable or permanently discontinue Retevmo based on severity. Based on data from animal reproduction studies and its mechanism of action, Retevmo can cause fetal harm when administered to a pregnant woman. Administration of selpercatinib to pregnant rats during organogenesis at maternal exposures that were approximately equal to those observed at the recommended human dose of 160 mg twice daily resulted in embryolethality and malformations. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Retevmo and for 1 week after the last dose. There are no data on the presence of selpercatinib or its metabolites in human milk or on their effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with Retevmo and for 1 week after the last dose. Severe adverse reactions (Grade 3-4) occurring in ≥ 20% of patients who received Retevmo in LIBRETTO-001, were hypertension (20%), diarrhea (5%), prolonged QT interval (4.8%), dyspnea (3.1%), fatigue (3.1%), hemorrhage (2.6%), abdominal pain (2.5%), vomiting (1.8%), headache (1.4%), nausea (1.1%), constipation (0.8%), edema (0.8%), rash (0.6%), and arthralgia (0.3%). Severe adverse reactions (Grade 3-4) occurring in ≥ 15% of patients who received Retevmo or chemotherapy with or without pembrolizumab in LIBRETTO-431 were hypertension (20% vs 3.1%), electrocardiogram QT prolonged (9% vs 0%), fatigue (3.2% vs 5%), edema (2.5% vs 0%), rash (1.9% vs 1.0%), diarrhea (1.3% vs 2.0%), abdominal pain (0.6% vs 2.0%), pyrexia (0.6% vs 0%), COVID19 infection (0.6% vs 0%), constipation (0% vs 1.0%), nausea (0% vs 1.0%), vomiting (0% vs 1.0%), and decreased appetite (0% vs 2.0%). Serious adverse reactions occurred in 44% of patients who received Retevmo in LIBRETTO-001. The most frequently reported serious adverse reactions (in ≥2% of patients) were pneumonia, pleural effusion, abdominal pain, hemorrhage, hypersensitivity, dyspnea, and hyponatremia. Fatal adverse reactions occurred in 3% of patients in LIBRETTO-001; fatal adverse reactions included sepsis (n=6), respiratory failure (n=5), hemorrhage (n=4), pneumonia (n=3), pneumonitis (n=2), cardiac arrest (n=2), sudden death (n=1), and cardiac failure (n=1). Serious adverse reactions occurred in 35% of patients who received Retevmo in LIBRETTO-431. The most frequently reported serious adverse reactions (≥2% of patients) were pleural effusion and abnormal hepatic function. Fatal adverse reactions occurred in 4.4% of patients who received Retevmo in LIBRETTO-431; fatal adverse reactions included myocardial infarction (n=2), respiratory failure (n=2), cardiac arrest, malnutrition, and sudden death (n=1 each). Common adverse reactions (all grades) occurring in ≥ 20% of patients who received Retevmo in LIBRETTO-001, were edema (49%), diarrhea (47%), fatigue (46%), dry mouth (43%), hypertension (41%), abdominal pain (34%), rash (33%), constipation (33%), nausea (31%), headache (28%), cough (24%), vomiting (22%), dyspnea (22%), hemorrhage (22%), arthralgia (21%), and prolonged QT interval (21%). Common adverse reactions (all grades) occurring in ≥ 15% of patients who received Retevmo or chemotherapy with or without pembrolizumab in LIBRETTO-431 were hypertension (48% vs 7%), diarrhea (44% vs 24%), edema (41% vs 28%), dry mouth (39% vs 6%), rash (33% vs 30%), fatigue (32% vs 50%), abdominal pain (25% vs 19%), musculoskeletal pain (25% vs 28%), constipation (22% vs 40%), electrocardiogram QT prolonged (20% vs 1.0%), COVID19 infection (19% vs 18%), stomatitis (18% vs 16%), decreased appetite (17% vs 34%), nausea (13% vs 44%), vomiting (13% vs 23%), and pyrexia (13% vs 23%). Laboratory abnormalities (all grades ≥ 20%; Grade 3-4) worsening from baseline in patients who received Retevmo in LIBRETTO-001, were increased AST (59%; 11%), decreased calcium (59%; 5.7%), increased ALT (56%; 12%), decreased albumin (56%; 2.3%), increased glucose (53%; 2.8%), decreased lymphocytes (52%; 20%), increased creatinine (47%; 2.4%), decreased sodium (42%; 11%), increased alkaline phosphatase (40%; 3.4%), decreased platelets (37%; 3.2%), increased total cholesterol (35%; 1.7%), increased potassium (34%; 2.7%), decreased glucose (34%; 1.0%), decreased magnesium (33%; 0.6%), increased bilirubin (30%; 2.8%), decreased hemoglobin (28%; 3.5%), and decreased neutrophils (25%; 3.2%). Laboratory abnormalities (all grades ≥ 20%; Grade 3-4) worsening from baseline in patients who received Retevmo or chemotherapy with or without pembrolizumab in LIBRETTO-431 were increased ALT (81%; 21% vs 63%; 4.1%), increased AST (77%; 10% vs 46%; 0%), decreased calcium (53%; 1.9% vs 24%; 1.0%), decreased platelets (53%; 3.2% vs 39%; 5%), decreased lymphocytes (53%; 8% vs 64%; 15%), decreased neutrophils (53%; 2.0% vs 58%; 11%), increased bilirubin (52%; 1.3% vs 9%; 0%), increased alkaline phosphatase (35%; 1.3% vs 22%; 0%), decreased sodium (31%; 3.2% vs 41%; 2.1%), decreased albumin (25%; 0% vs 5%; 0%), increased blood creatinine (23%; 0% vs 21%; 0%), decreased hemoglobin (21%; 0% vs 91%; 5%), decreased potassium (17%; 1.3% vs 15%; 1.0%), and decreased magnesium (16%; 0.6% vs 8%; 0%). Concomitant use of acid-reducing agents decreases selpercatinib plasma concentrations which may reduce Retevmo anti-tumor activity. Avoid concomitant use of proton-pump inhibitors (PPIs), histamine-2 (H2) receptor antagonists, and locally acting antacids with Retevmo. If coadministration cannot be avoided, take Retevmo with food (with a PPI) or modify its administration time (with a H2 receptor antagonist or a locally acting antacid). Concomitant use of strong and moderate CYP3A inhibitors increases selpercatinib plasma concentrations which may increase the risk of Retevmo adverse reactions including QTc interval prolongation. Avoid concomitant use of strong and moderate CYP3A inhibitors with Retevmo. If concomitant use of a strong or moderate CYP3A inhibitor cannot be avoided, reduce the Retevmo dosage as recommended and monitor the QT interval with ECGs more frequently. Concomitant use of strong and moderate CYP3A inducers decreases selpercatinib plasma concentrations which may reduce Retevmo anti-tumor activity. Avoid coadministration of Retevmo with strong and moderate CYP3A inducers. Concomitant use of Retevmo with CYP2C8 and CYP3A substrates increases their plasma concentrations which may increase the risk of adverse reactions related to these substrates. Avoid coadministration of Retevmo with CYP2C8 and CYP3A substrates where minimal concentration changes may lead to increased adverse reactions. If coadministration cannot be avoided, follow recommendations for CYP2C8 and CYP3A substrates provided in their approved product labeling. Retevmo is a P-glycoprotein (P-gp) and BCRP inhibitor. Concomitant use of Retevmo with P-gp or BCRP substrates increases their plasma concentrations, which may increase the risk of adverse reactions related to these substrates. Avoid coadministration of Retevmo with P-gp or BCRP substrates where minimal concentration changes may lead to increased adverse reactions. If coadministration cannot be avoided, follow recommendations for P-gp and BCRP substrates provided in their approved product labeling. No dosage modification is recommended for patients with mild to severe renal impairment (estimated Glomerular Filtration Rate [eGFR] ≥15 to 89 mL/min, estimated by Modification of Diet in Renal Disease [MDRD] equation). A recommended dosage has not been established for patients with end-stage renal disease. Reduce the dose when administering Retevmo to patients with severe hepatic impairment (total bilirubin greater than 3 to 10 times upper limit of normal [ULN] and any AST). No dosage modification is recommended for patients with mild or moderate hepatic impairment. Monitor for Retevmo-related adverse reactions in patients with hepatic impairment. Retevmo (selpercatinib) is available as 40 mg and 80 mg capsules, and 40 mg, 80 mg, 120 mg, and 160 mg tablets. SE HCP ISI LA_NOV2025 Please see full Prescribing Information, including Instructions for Use , for Retevmo. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. 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Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Retevmo as a potential treatment for rearranged during transfection (RET) fusion-positive stage IB-IIIA NSCLC following completion of definitive radiotherapy or surgery with curative intent, and other adjuvant therapy if indicated, and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, or that Retevmo will receive additional regulatory approvals. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Endnotes & References Retevmo. Prescribing information. Lilly USA, LLC. SOURCE Eli Lilly and Company 21% more press release views with Request a Demo