RETEVMO
RETEVMO- selpercatinib capsule
Eli Lilly and Company
1 INDICATIONS AND USAGE
1.1 RET Fusion-Positive Non-Small Cell Lung Cancer
RETEVMO® is 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.
1.2 RET -Mutant Medullary Thyroid Cancer
RETEVMO is indicated for the treatment of 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.
This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
1.3 RET Fusion-Positive Thyroid Cancer
RETEVMO is indicated for the treatment of 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).
This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.3)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
1.4 Other RET Fusion-Positive Solid Tumors
RETEVMO is indicated for the treatment of 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.
This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.4)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
Select patients for treatment with RETEVMO based on the presence of a RET gene fusion (NSCLC, thyroid cancer, or other solid tumors) or specific RET gene mutation (MTC) in tumor specimens [see Clinical Studies (14)]. Information on FDA-approved test(s) for the detection of RET gene fusions and RET gene mutations is available at: http://www.fda.gov/CompanionDiagnostics. An FDA-approved companion diagnostic test for the detection of RET gene fusions and RET gene mutations in plasma or in tumors other than NSCLC and thyroid cancer is not currently available.
2.2 Important Administration Instructions
RETEVMO may be taken with or without food unless coadministered with a proton pump inhibitor (PPI) [see Dosage and Administration (2.4), Clinical Pharmacology (12.3)].
2.3 Recommended Dosage
The recommended dosage of RETEVMO based on body weight is:
- Less than 50 kg: 120 mg
- 50 kg or greater: 160 mg
Take RETEVMO orally twice daily (approximately every 12 hours) until disease progression or unacceptable toxicity.
Swallow the capsules whole. Do not crush or chew the capsules.
Do not take a missed dose unless it is more than 6 hours until next scheduled dose.
If vomiting occurs after RETEVMO administration, do not take an additional dose and continue to the next scheduled time for the next dose.
2.4 Dosage Modifications for Concomitant Use of Acid-Reducing Agents
Avoid concomitant use of a PPI, a histamine-2 (H2) receptor antagonist, or a locally-acting antacid with RETEVMO [see Drug Interactions (7.1)]. If concomitant use cannot be avoided:
- Take RETEVMO with food when coadministered with a PPI.
- Take RETEVMO 2 hours before or 10 hours after administration of an H2 receptor antagonist.
- Take RETEVMO 2 hours before or 2 hours after administration of a locally-acting antacid.
2.5 Dosage Modifications for Adverse Reactions
The recommended dose reductions for adverse reactions are provided in Table 1.
Dose Reduction | Patients WeighingLess Than 50 kg | Patients Weighing50 kg or Greater |
First | 80 mg orally twice daily | 120 mg orally twice daily |
Second | 40 mg orally twice daily | 80 mg orally twice daily |
Third | 40 mg orally once daily | 40 mg orally twice daily |
Permanently discontinue RETEVMO in patients unable to tolerate three dose reductions.
The recommended dosage modifications for adverse reactions are provided in Table 2.
Adverse Reaction | Severity | Dosage Modification |
Hepatotoxicity[see Warnings and Precautions (5.1)] | Grade 3orGrade 4 |
|
Interstitial Lung Disease/ Pneumonitis[see Warnings and Precautions (5.2)] | Grade 2 |
|
Grade 3 orGrade 4 |
| |
Hypertension[see Warnings and Precautions (5.3)] | Grade 3 |
|
Grade 4 |
| |
QT Interval Prolongation[see Warnings and Precautions (5.4)] | Grade 3 |
|
Grade 4 |
| |
Hemorrhagic Events[see Warnings and Precautions (5.5)] | Grade 3orGrade 4 |
|
Hypersensitivity Reactions[see Warnings and Precautions (5.6)] | All Grades |
|
Hypothyroidism[see Warnings and Precautions (5.9)] | Grade 3 orGrade 4 |
|
Other Adverse Reactions[see Adverse Reactions (6.1)] | Grade 3orGrade 4 |
|
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