The following information helps you to find FDA Alerts and Pharmacist’s Applications to Practice quickly and easily. In cooperation with the Food and Drug Administration (FDA), and as a service to our members, HOPA periodically distributes information about newly approved therapies for cancer patients from FDA’s Office of Oncology Drug Products Director, Dr. Richard Pazdur to inform oncologists and professionals in oncology-related fields in a timely manner. Links to product labels will take you to relevant clinical information on the indication, contraindications, dosing, and safety. In sending this information, HOPA does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described.

Along with HOPA’s Publications Committee, members also review new drug updates and provide analysis and research on the application of these new drugs or indications. Pharmacist’s Applications to Practice, or PAP, are listed after drugs that include the additional analysis.

You can also find additional information on FDA Alerts and Updates by listening to FDA Drug Safety Podcasts.

September 28, 2018, with PAP

On Sept. 28, 2018, the Food and Drug Administration approved cemiplimab-rwlc (LIBTAYO, Regeneron Pharmaceuticals Inc.) for patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

Approval was based on clinically meaningful and durable objective response rates (ORR) observed in patients with advanced CSCC who were treated with cemiplimab-rwlc in two clinical trials: R2810-ONC-1423, an open-label, multi-center, dose-finding trial with expansion cohorts in patients with various advanced solid tumors; and R2810-ONC-1540, an open-label, multi-center, non-randomized, multicohort trial in patients with metastatic or locally advanced CSCC regardless of prior treatment, for whom surgery or radiation was not recommended.

ORR was assessed by an independent review committee according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for patients with metastatic CSCC. A composite response assessment incorporating clinical response criteria using digital photography and RECIST 1.1 was used for those with locally advanced CSCC.

Among 108 patients with advanced CSCC, including metastatic (N=75) or locally advanced (N=33) disease, the ORR was 47% (95% CI: 38, 57), with 4% complete and 44% partial response rates. The ORR was 47% (95% CI: 35, 59) for the 75 patients with metastatic CSCC and 49% (95% CI: 31, 67) for those with locally advanced disease. The median response duration was not reached (range: 1.0 to 15.2+ months), and 61% of responses were durable for 6 months or longer. Response rates and durability results were consistent across the advanced CSCC subtypes. For patients with locally advanced CSCC, radiographic response rate correlated with clinically relevant shrinkage of visible and often disfiguring tumors demonstrated in the photographic data.

Safety data were evaluated in 534 patients who received cemiplimab-rwlc in both trials. Serious adverse reactions are immune-mediated adverse reactions (e.g., pneumonitis, hepatitis, colitis, adrenal insufficiency, hypo- and hyperthyroidism, diabetes mellitus and nephritis) and infusion reactions. The most common adverse reactions were fatigue, rash and diarrhea.

The recommended cemiplimab-rwlc dose and schedule is 350 mg as an intravenous infusion over 30 minutes every 3 weeks.

View full prescribing information for LIBTAYO.

Cemiplimab-rwlc received breakthrough therapy designation for this indication, and the application was granted priority review. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

Pharmacist's Applications to Practice

Cemiplimab for Metastatic or Locally Advanced Cutaneous Small-Cell Carcinoma (cSCC)

Author: Zachary Rivers, PharmD
Oncology Pharmacist
M Health/Fairview Pharmacy Services
Minneapolis, MN
PhD Candidate
University of Minnesota College of Pharmacy
Minneapolis, MN

What is the potential role for cemiplimab in the treatment of metastatic or locally advanced cSCC?

  • Cemiplimab is the first programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1) agent approved for metastatic or locally advanced cSCC.
  • The agent has been incorporated into the National Comprehensive Cancer Network guidelines for nonmelanoma skin cancer as a level 2A recommendation for patients with nonoperable disease.1
  • No other agents have been studied in well-powered clinical trials of patients with this disease state.
  • Phase 2 studies have been conducted with cisplatin, cetuximab, and cisplatin/cetuximab in combination but have produced mixed results and expected toxicities.2,3
  • U.S. Food and Drug Administration (FDA) approval was granted on the basis of two clinical trials.4
    • R2810-ONC-1423
      • Phase 1 open-label trial in advanced solid tumors, including 26 patients with cSCC
      • 50% response rate as the primary outcome, with an average of 2.3 months to response
    • R2810-ONC-1450
      • Phase 2 nonrandomized open-label trial in 59 patients with advanced cSCC
      • 47% response rate as the primary outcome, with an average of 1.9 months to response
      • Median progression-free survival and overall survival not reached by study data cutoff

What role can the pharmacist play in the management of patients on cemiplimab?

  • Dosing
    • 350 mg cemiplimab IV over 30 minutes every 3 weeks, per pharmacokinetic studies. This dose is different from that in the R2180-ONC studies.5
    • No adjustments are made for hepatic or renal impairments that are not immune related.
  • Drug-Drug and Drug-Food Interactions
    • No studies of interactions have been conducted for this medication.
    • No information is provided regarding concurrent use of corticosteroids, compared to other PD-1/PD-L1 medications.
  • Adverse Events6
    • Grades 3 and 4
      • Musculoskeletal pain (3%)
      • Fatigue (2%)
      • Rash (1.2%)
      • Diarrhea (0.6%)
    • Occurring in more than 20% of patients at all levels of severity
      • Fatigue (29%)
      • Rash (25%)
      • Diarrhea (22%)
    • Management
      • Adverse effects are generally mediated via an immune activation pathway.
      • Administer appropriate doses of corticosteroids (1 to 2 mg/kg/day of prednisone equivalents) until symptoms are controlled and then taper for over 1 month.7
      • Administer appropriate hormone replacement if adverse effects result in suppressed hormone function such as thyroid hormone.
    • Withholding therapy
      • See Table 1 in package insert for specific durations and severity cutoffs.6
      • Generally, withhold therapy and rechallenge for grades 1–2, and permanently discontinue for grade 4. For grade 3 toxicity, the decision depends on the site of immune toxicity.

Clinical Pearls4,6

  • The drug is supplied as a 350-mg/7-ml vial.
  • Dilute in 0.9% sodium chloride or 5% dextrose, 50 ml.
  • Administer via a 0.2- to 5-micron filter.
  • Currently no PD-1/PD-L1 biomarker screening data are available.

Patients were excluded if they were currently or recently on immunosuppressive therapy and if they had previous exposure to a PD-1/PD-L-1 agent.


1.     National Comprehensive Cancer Network. Squamous Cell Skin Cancer. Version 2.2019. Retrieved February 24, 2019, from
2.     Jarkowski A 3rd, Hare R, Loud P, et al. Systemic therapy in advanced cutaneous squamous cell carcinoma (cSCC): the Roswell Park experience and a review of the literature. Am J Clin Oncol. 2016;39(6):545-548.
3.     Trodello C, Pepper JP, Wong M, Wysong A. Cisplatin and cetuximab treatment for metastatic cutaneous squamous cell carcinoma: a systematic review. Dermatol Surg. 2017;43(1):40-49.
4.     Migden MR, Rischin D, Schmults CD, et al. PD-1 blockade with cemiplimab in advanced cutaneous squamous-cell carcinoma. N Engl J Med. 2018;379(4):341-351.
5.     Markham A, Duggan S. Cemiplimab: first global approval. Drugs. 2018;78(17):1841-1846.
6.     Libtayo (cemiplimab-rwlc) [package insert]. Tarrytown, NY, and Bridgewater, NJ: Regeneron Pharmaceuticals and Sanofi-Aventis US, LLC; January 2019.
7.     National Comprehensive Cancer Network. Management of Immunotherapy-Related Toxicities. Version 1.2019. Retrieved February 25, 2019, from