HIGHLIGHTS OF PRESCRIBING INFORMATION …

1 HIGHLIGHTS OF PRESCRIBING INFORMATION DOSAGE FORMS AND STRENGTHS . These HIGHLIGHTS do not include all the INFORMATION needed to use LIBTAYO safely Injection: 350 mg/7 mL (50 mg/mL) solution in a single-dose vial. (3). and effectively. See full PRESCRIBING INFORMATION for LIBTAYO. LIBTAYO (cemiplimab-rwlc) injection, for intravenous use CONTRAINDICATIONS . Initial Approval: 2018 None. (4). RECENT MAJOR CHANGES . WARNINGS AND PRECAUTIONS . Immune-Mediated Adverse Reactions ( ). Indications and Usage ( , ) 02/2021. Dosage and Administration ( ) 02/2021 Immune-mediated adverse reactions, which may be severe or fatal, Dosage and Administration ( ) 11/2020 can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated Warnings and Precautions ( , ) 11/2020 hepatitis, immune-mediated endocrinopathies, immune-mediated Warnings and Precautions ( ) 02/2021 dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection.

2 INDICATIONS AND USAGE Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated: Withhold or permanently discontinue LIBTAYO based on the severity of Cutaneous Squamous Cell Carcinoma (CSCC) reaction. ( ). for the treatment of patients with metastatic cutaneous squamous cell carcinoma Infusion-Related Reactions: Interrupt, slow the rate of infusion, or permanently (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for discontinue based on severity of reaction. ( , ). curative surgery or curative radiation.

3 ( ). Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT): Basal Cell Carcinoma (BCC) Fatal and other serious complications can occur in patients who receive for the treatment of patients with locally advanced BCC (laBCC) previously allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway antibody. ( ). inhibitor is not appropriate. ( ). Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive for the treatment of patients with metastatic BCC (mBCC) previously treated with potential of the potential risk to a fetus and use of effective contraception.

4 ( , a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not , ). ( ). 1. The mBCC indication is approved under accelerated approval based on tumor ADVERSE REACTIONS . response rate and durability of response. Continued approval for mBCC may be The most common adverse reactions ( 15%) were musculoskeletal pain, fatigue, rash, contingent upon verification and description of clinical benefit. and diarrhea. The most common Grade 3-4 laboratory abnormalities ( 2%). Non-Small Cell Lung Cancer (NSCLC) were lymphopenia, hyponatremia, hypophosphatemia, increased aspartate aminotransferase, anemia, and hyperkalemia. ( ). for the first-line treatment of patients with NSCLC whose tumors have high PD-L1.

5 Expression [Tumor Proportion Score (TPS) 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is: To report SUSPECTED ADVERSE REACTIONS, contact Regeneron at 1-877-542-8296 or FDA at 1-800-FDA-1088 or locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or USE IN SPECIFIC POPULATIONS . metastatic. ( , ). Lactation: Advise not to breastfeed. ( ). DOSAGE AND ADMINISTRATION . The recommended dosage of LIBTAYO is 350 mg as an intravenous infusion over 30 See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. minutes every 3 weeks. ( ) Revised: 02/2021. FULL PRESCRIBING INFORMATION : CONTENTS* 8 USE IN SPECIFIC POPULATIONS.

6 1 INDICATIONS AND USAGE Pregnancy Cutaneous Squamous Cell Carcinoma Lactation Basal Cell Carcinoma Females and Males of Reproductive Potential Non-Small Cell Lung Cancer Pediatric Use Geriatric Use 2 DOSAGE AND ADMINISTRATION. 11 DESCRIPTION. Patient Selection for NSCLC. 12 CLINICAL PHARMACOLOGY. Recommended Dosage Mechanism of Action Dosage Modifications for Adverse Reactions Pharmacokinetics Preparation and Administration 13 NONCLINICAL TOXICOLOGY. 3 DOSAGE FORMS AND STRENGTHS Carcinogenesis, Mutagenesis, Impairment of Fertility 4 CONTRAINDICATIONS Animal Toxicology and/or Pharmacology 5 WARNINGS AND PRECAUTIONS 14 CLINICAL STUDIES. Severe and Fatal Immune-Mediated Adverse Reactions Cutaneous Squamous Cell Carcinoma (CSCC).

7 Infusion-Related Reactions Basal Cell Carcinoma (BCC). Complications of Allogeneic HSCT Non-Small Cell Lung Cancer (NSCLC). Embryo-Fetal Toxicity 16 HOW SUPPLIED/STORAGE AND HANDLING. 6 ADVERSE REACTIONS 17 PATIENT COUNSELING INFORMATION . Clinical Trials Experience * Sections or subsections omitted from the full PRESCRIBING INFORMATION are not Immunogenicity listed. FULL PRESCRIBING INFORMATION Basal Cell Carcinoma 1 INDICATIONS AND USAGE LIBTAYO is indicated for the treatment of patients: with locally advanced basal cell carcinoma (laBCC) previously treated with a Cutaneous Squamous Cell Carcinoma hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not LIBTAYO is indicated for the treatment of patients with metastatic cutaneous squamous appropriate.

8 Cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for with metastatic BCC (mBCC) previously treated with a hedgehog pathway inhibitor curative surgery or curative radiation. or for whom a hedgehog pathway inhibitor is not appropriate. The mBCC indication is approved under accelerated approval based on tumor response rate and durability Table 1: Recommended Dosage Modifications for Adverse Reactions of response. Continued approval for the mBCC indication may be contingent upon (continued). verification and description of clinical benefit. Adverse Reaction Severitya Dosage Modifications Non-Small Cell Lung Cancer Suspected SJS, TEN, or Withholdb LIBTAYO is indicated for the first-line treatment of patients with non-small cell lung cancer Exfoliative Dermatologic DRESS.

9 (NSCLC) whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) Conditions Confirmed SJS, TEN, or Permanently discontinue 50%] as determined by an FDA-approved test [see Dosage and Administration ( )]), with DRESS. no EGFR, ALK or ROS1 aberrations, and is: Myocarditis Grade 2, 3 or 4 Permanently discontinue locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or Grade 2 Withholdb Neurological Toxicities metastatic. Grades 3 or 4 Permanently discontinue 2 DOSAGE AND ADMINISTRATION Other Adverse Reactions Patient Selection for NSCLC Infusion-related reactions Interrupt or slow the rate Grade 1 or 2 of infusion Select patients with locally advanced or metastatic NSCLC for treatment with LIBTAYO [see Warnings and based on PD-L1 expression on tumor cells [see Clinical Studies ( )].]

10 Precautions ( )] Grade 3 or 4 Permanently discontinue INFORMATION on FDA-approved tests for the detection of PD-L1 expression is available at: ALT=alanine aminotransferase, AST=aspartate aminotransferase, ULN=upper limit of normal, SJS=Stevens-Johnson Syndrome, TEN=toxic epidermal necrolysis, DRESS=Drug Rash with Eosinophilia and Systemic Symptoms Recommended Dosage a Based on National Cancer Institute Common Terminology Criteria for Adverse Events, The recommended dosage of LIBTAYO is 350 mg administered as an intravenous infusion Version over 30 minutes every 3 weeks until disease progression or unacceptable toxicity. b Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid Dosage Modifications for Adverse Reactions taper.