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Lilly
's
Retevmo
® (
selpercatinib
) Phase 3 Results in
RET
Fusion-Positive NSCLC
and
RET
-
Mutant Medullary Thyroid Cancer
Both Published in The New England Journal of Medicine and Presented in a Presidential Symposium at ESMO Congress 2023
2023-10-21
·
BioSpace
临床结果
临床3期
加速审批
In the Phase 3 LIBRETTO-431 study,
Retevmo
more than doubled progression-free survival (PFS) compared to chemotherapy plus
pembrolizumab
in patients with advanced or metastatic rearranged
during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC)
In the Phase 3 LIBRETTO-531 study,
Retevmo
provided a 72% improvement in PFS compared to
cabozantinib
or
vandetanib
in patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) INDIANAPOLIS, Oct. 21, 2023 /PRNewswire/ --
Eli
Lilly and Company
(NYSE: LLY) today announced results from both the LIBRETTO-431 Phase 3 study, which evaluated
Retevmo
® (
selpercatinib
) versus platinum-based chemotherapy — with or without
pembrolizumab
— as an initial treatment for patients with advanced or metastatic rearranged
during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC)
, and the LIBRETTO-531 Phase 3 study, which evaluated
Retevmo
versus multikinase inhibitors (MKIs) in patients with advanced or metastatic
RET-mutant medullary thyroid cancer (MTC)
. In both clinical studies, results were based on pre-specified interim efficacy analyses conducted by independent data monitoring committees (IDMC). Results from the LIBRETTO-431 and LIBRETTO-531 Phase 3 trials were presented in a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2023 and simultaneously published in the New England Journal of Medicine. "These results from LIBRETTO-431 and LIBRETTO-531 are striking and provide critical evidence supporting the importance of optimizing initial therapy for patients with
RET-driven cancers
," said David Hyman, M.D., chief medical officer,
Lilly
. "We are excited to be sharing these data with the clinical community in both NEJM and at ESMO. It is our hope that these data lead to further adoption of biomarker testing in the initial treatment journey for people with
NSCLC
and MTC and help make
Retevmo
a standard initial treatment option for all appropriate patients." The labeling for Retevmo contains warnings and precautions for hepatotoxicity (evidence of liver dysfunction),
interstitial lung disease (ILD)/pneumonitis
,
hypertension
, QT interval prolongation,
hemorrhagic events
,
hypersensitivity
,
tumor lysis syndrome
, risk of impaired wound healing,
hypothyroidism
, and embryo-fetal toxicity.
RET
Fusion-Positive NSCLC
: Data from LIBRETTO-431 LIBRETTO-431 is a Phase 3, randomized, open-label trial that evaluated
Retevmo
in patients with advanced or metastatic, treatment-naïve
RET
fusion-positive NSCLC
. In the study, patients were randomly assigned to receive
Retevmo
, or
pemetrexed
and the investigator's choice of platinum-based chemotherapy (
cisplatin
or
carboplatin
) with or without
pembrolizumab
— which is a current first-line standard of care treatment option. LIBRETTO-431 is the first randomized trial that compared the safety and effectiveness of a targeted therapy to a
PD-1
inhibitor plus chemotherapy in a biomarker-selected
NSCLC
patient population. The primary endpoint was tested first in patients stratified by intent-to-treat (ITT) with
pembrolizumab
if assigned to the control arm (ITT-
pembrolizumab
), then tested in the ITT population if deemed positive. "These data provide clear evidence that
Retevmo
offers highly meaningful clinical impact for patients diagnosed with
RET
fusion-positive NSCLC
and it should be considered as the first treatment option for these patients," said Caicun Zhou, M.D., Ph.D., director and professor at the
Cancer
Institute of Tongji University School of Medicine and
Shanghai Pulmonary Hospital
, and LIBRETTO-431 primary investigator. "While there is often urgency to treat, these results further highlight the importance of incorporating routine biomarker testing into a patient's care plan to direct early clinical decision-making towards the most effective therapies." A total of 256 patients received at least one dose of study treatment (Retevmo, 158; control arm, 98). Of the 261 patients in the ITT population, 159 were randomly assigned to
Retevmo
and 102 to the control arm. Of the 212 patients in the ITT-
pembrolizumab
population, 129 were randomly assigned to
Retevmo
and 83 to
pembrolizumab
with chemotherapy. Patients randomized to the control arm who had disease progression confirmed by blinded independent central review (BICR) were eligible for optional crossover to
Retevmo
. In the ITT-
pembrolizumab
population, the median PFS by BICR was 24.8 months (95% CI: 16.9, not estimable [NE]) with
Retevmo
versus 11.2 months (95% CI: 8.8, 16.8) in the control arm, corresponding to a hazard ratio (HR) of 0.465 (95% CI: 0.309, 0.699; p<0.001). PFS was longer with
Retevmo
than in the control arm across all pre-specified subgroups. The overall response rate (ORR) by BICR with
Retevmo
was 83.7% (95% CI: 76.2, 89.6) compared to 65.1% (95% CI: 53.8, 75.2) in the control arm. Similar results were observed in the ITT population in both BICR and investigator-assessed endpoints and across all pre-specified subgroups.
Retevmo
demonstrated superior PFS with an HR of 0.482 (95% CI: 0.331, 0.700; p<0.001) and an increase of more than 13 months in median PFS by BICR, showing 24.8 months (95% CI: 17.3, NE) with
Retevmo
versus 11.2 months (95% CI: 8.8, 16.8) with control. Overall survival (OS) results remain immature with a censoring rate of approximately 80% (HR 0.961, 95% CI: 0.503, 1.835) in the ITT-
pembrolizumab
arm. Intracranial baseline assessments were available for evaluation by neuroradiologic BICR for 192 patients in the central nervous system
(CNS)-pembrolizumab
population (Retevmo, 120; control arm, 72). Time to CNS progression was longer with
Retevmo
than in the control arm (cause-specific HR: 0.28; 95% CI: 0.12, 0.68), with eight patients (6.7%) on
Retevmo
having a first event of CNS progression compared to 13 patients (18.1%) in the control arm. Forty-two of the 192 patients (21.9%) were confirmed to have brain metastases at baseline, of which 29 were measurable (
Retevmo
, 17; control arm, 12). In the patients with measurable baseline brain metastases, the intracranial response rate for those who received
Retevmo
was 82.4% (95% CI: 56.6, 96.2) versus 58.3% (95% CI: 27.7, 84.8) in the control arm. Complete responses were observed in 35.3% of patients with
Retevmo
versus 16.7% in the control arm. Median intracranial response duration was not yet mature, but at 12 months, 76.0% of patients remained in response with
Retevmo
versus 62.5% in the control arm.
RET
-Mutant MTC: Data from LIBRETTO-531 LIBRETTO-531 is a Phase 3, randomized, open-label trial that evaluated
Retevmo
versus physician's choice of MKIs
cabozantinib
or
vandetanib
, which are currently approved first-line options for patients with advanced or metastatic, kinase inhibitor-naïve
RET
-mutant MTC. It is the first randomized trial that compared the safety and effectiveness of a highly selective
RET-kinase inhibitor
RET-kinase
inhibitor versus MKIs in this population. "The magnitude of benefit observed in patients treated with
Retevmo
makes clear that it should become the standard of care for the initial systemic treatment of patients with
progressive advanced RET-mutant MTC
," said Julien Hadoux, M.D., Ph.D., medical oncologist at the Gustave Roussy
Cancer
Center and LIBRETTO-531 investigator. "These data should prove to be practice-changing for clinicians caring for patients with MTC and lead to routine biomarker testing." A total of 291 patients with progressive
RET-mutant MTC
and no prior history of MKI therapy for advanced or metastatic disease were randomized in the study. One hundred and ninety-three patients were randomized to the
Retevmo
arm and 98 to the control arm to receive investigator's choice of
cabozantinib
(73) or
vandetanib
(25). Patients randomized to the control arm who experienced disease progression confirmed by BICR were eligible to cross over to
Retevmo
. At the interim analysis, the study had met the criteria for positive PFS. At a median follow-up of approximately 12 months, the BICR-assessed median PFS in the
Retevmo
arm was not reached and remained inestimable (95% CI, NE to NE), whereas the BICR-assessed median PFS in the control arm was 16.8 months (95% CI: 12.2, 25.1). This corresponded to a HR of 0.280 (95% CI: 0.165, 0.475; p<0.0001). Investigator-assessed PFS yielded similar results with an HR of 0.187 (95% CI: 0.109, 0.321; p<0.0001). Both BICR and investigator-assessed PFS were longer with
Retevmo
across all pre-planned subgroups. Treatment with
Retevmo
resulted in a significant improvement in treatment failure-free survival (TFFS) with an HR of 0.254 (95% CI: 0.153, 0.423; p<0.001). The ORR with
Retevmo
was 69.4% (95% CI: 62.4, 75.8) compared to 38.8% (95% CI: 29.1, 49.2) in the control arm (95% CI: 2.2, 6.3). OS results remain immature with a censoring rate of more than 90%, although a favorable trend was observed (HR 0.374, 95% CI: 0.147, 0.949). The safety pro for
Retevmo
in both studies was generally consistent with those identified across the previously reported
Retevmo
development program (LIBRETTO-001, LIBRETTO-121, LIBRETTO-321). About
RET
-
Driven Cancers
Genomic alterations in the
RET kinase
, which include fusions and activating point mutations, lead to overactive
RET
signaling and uncontrolled cell growth.
RET
fusions have been identified in approximately 1% to 2% of all
NSCLC
cases.
NSCLC
accounts for about 85% of all
lung cancer
diagnoses in the U.S., of which approximately 50% have actionable biomarkers. MTC accounts for 1% to 2% of
thyroid cancers
in the U.S.
RET
mutations are found in up to 50% of
sporadic MTC
and over 90% of
hereditary MTC
. About LIBRETTO-431 LIBRETTO-431 is a randomized Phase 3 clinical trial of patients with advanced or metastatic, treatment-naïve
RET
fusion-positive NSCLC
. The trial enrolled 261 patients with advanced or metastatic
RET
fusion-positive NSCLC
who had received no prior systemic therapy for metastatic disease. Enrolled trial participants were randomized 2:1 to receive either
selpercatinib
or platinum-based chemotherapy (
carboplatin
or
cisplatin
) and
pemetrexed
therapy with or without
pembrolizumab
as initial treatment of their
advanced or metastatic RET fusion-positive NSCLC
.
RET
fusions may be identified using local testing. This trial's primary endpoint is PFS, and secondary endpoints include OS, ORR, duration of response (DOR), and intracranial ORR. For patients randomized to the control arm, crossover was allowed at progression. About LIBRETTO-531 LIBRETTO-531 is a randomized Phase 3 clinical trial of patients with progressive, advanced or metastatic, kinase inhibitor-naïve
RET
-mutant MTC. The trial enrolled 291 patients, and participants were randomized 2:1 to receive either
selpercatinib
or physician's choice of
cabozantinib
or
vandetanib
as initial treatment of their advanced or metastatic RET-mutant MTC.
RET
mutations may be identified using local testing. This trial's primary endpoint is PFS, and secondary endpoints include TFFS, ORR, DOR, and OS. For patients randomized to the control arm, crossover was allowed at progression. About
Retevmo
® (
selpercatinib
, 40 mg & 80 mg capsules)
Retevmo
(
selpercatinib
, formerly known as
LOXO-292
) (pronounced reh-TEHV-moh) is a highly selective and potent
RET kinase inhibitor
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. INDICATIONS FOR
RETEVMO
®
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. 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.1 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).1 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. 1 1 This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). 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 the 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 the 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
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
.
Hypersensitivity
occurred in 6% of patients receiving
Retevmo
, including
Grade 3 hypersensitivity
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
. 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%). Serious adverse reactions occurred in 44% of patients who received
Retevmo
. 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; 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). 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%). 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%). Concomitant use of acid-reducing agents decreases
selpercatinib
plasma concentrations which may reduce Retevmo antitumor 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
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
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)
inhibitor. Concomitant use of
Retevmo
with
P-gp
substrates increases their plasma concentrations, which may increase the risk of adverse reactions related to these substrates. Avoid coadministration of
Retevmo
with
P-gp
substrates where minimal concentration changes may lead to increased adverse reactions. If coadministration cannot be avoided, follow recommendations for
P-gp
substrates provided in their approved product labeling. The safety and effectiveness of
Retevmo
have not been established in pediatric patients less than 12 years of age. The safety and effectiveness of
Retevmo
have been established in pediatric patients aged 12 years and older for
medullary thyroid cancer (MTC)
who require systemic therapy and for
advanced RET fusion-positive thyroid cancer
who require systemic therapy and are radioactive iodine-refractory (if radioactive iodine is appropriate). Use of
Retevmo
for these indications is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 12 years and older. Monitor open growth plates in adolescent patients. Consider interrupting or discontinuing
Retevmo
if abnormalities occur. 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. Please see full Prescribing Information for
Retevmo
. SE HCP ISI All_21SEP22 About
Lilly
Lilly
unites caring with discovery to create medicines that make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges, redefining
diabetes
care, treating
obesity
and curtailing its most devastating long-term effects, advancing the fight against
Alzheimer's disease
, providing solutions to some of the most debilitating
immune system disorders
, and transforming the most difficult-to-treat
cancers
into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit
Lilly.com
and Lilly.com/news or follow us on Facebook, Instagram, Twitter and LinkedIn. P-LLY
Retevmo
® is a registered trademark owned by or licensed to
Eli
Lilly and Company
, its subsidiaries, or affiliates. ©Lilly USA, LLC 2023. ALL RIGHTS RESERVED.
Lilly
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
® (
selpercatinib
) as a potential treatment for people with
locally advanced and metastatic RET fusion-positive NSCLC
and
RET
-mutant MTC 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, or that they will be commercially successful. 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. View original content to download multimedia: SOURCE
Eli
Lilly and Company
Company Codes: NYSE:LLY
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