Regulatory Decision Summary for Libtayo

Review decision

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.


Product type:

Drug

Medicinal ingredient(s):

cemiplimab

Therapeutic area:

Antineoplastic Agent

Type of submission:

Supplement to a New Drug Submission

Control number:

256178
What was the purpose of this submission?

 

The purpose of this submission was to seek marketing authorization for Libtayo (cemiplimab for injection), an anti-PD-1 monoclonal antibody therapy, for the treatment of women with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

After evaluation of the submitted data package, Health Canada authorized Libtayo for the following indication:

Libtayo (cemiplimab for injection) is indicated for:

  • the treatment of adult patients with cervical cancer who have progressed on or after prior platinum-based chemotherapy and who require additional systemic therapy to treat recurrent or metastatic disease.

 

Why was the decision issued?

 

The authorization of Libtayo (cemiplimab for injection) was based on results of a randomized, open-label, multi-center study in women (≥ 18 years old) who progressed on or after prior platinum-based chemotherapy and who have recurrent or metastatic cervical cancer. A total of 608 patients were randomized 1:1 to receive either Libtayo (n = 304) or investigator’s choice (IC) chemotherapy (n = 304). The primary efficacy outcome measure was overall survival (OS) supported by key secondary efficacy outcome measures of progression-free survival (PFS) and overall response rates (ORR).

Cervical cancer patients randomized to the Libtayo arm had a median OS of 12 months compared to only 8.5 months for patients randomized to IC chemotherapy with a Kaplan-Meier hazard ratio (HR) of 0.69. This difference was statistically significant and is considered a clinically meaningful benefit for Libtayo over IC chemotherapy in the treatment of cervical cancer patients who have limited effective treatment options. The OS benefit was supported by improvements in PFS and ORR for patients randomized to Libtayo compared patients randomized to IC chemotherapy. The PFS HR was 0.75 in favour of Libtayo and more patients achieved an ORR when treated with Libtayo (16%) compared to patients treated with IC chemotherapy (6%).

The safety profile of Libtayo in women with cervical cancer was consistent with the known safety profile for this anti-PD-1 monoclonal antibody in other authorized indications. Approximately 10% of patients treated with Libtayo experienced an adverse event of special interest (AESI). These are well-described immune-mediated adverse reactions associated with this class of products and while concerning, these AESIs are also well-documented and dose modifications are in place to manage these events. Permanent discontinuations due to adverse events occurred in 9% of patients treated with Libtayo, which included pneumonitis (2%). The most common Grade 3 or 4 adverse events (> 2%) were anemia, urinary tract infection, hypokalemia, asthenia, and hydronephrosis.

The recommended dose of Libtayo is 350 mg every three (3) weeks administered as an intravenous infusion over 30 minutes for 96 weeks or until disease progression or unacceptable toxicity, whichever occurs first.  Refer to the Product Monograph for details including recommended dose delays for toxicities.

Overall, the benefit-risk profile for Libtayo is considered positive for the treatment of women with cervical cancer who have progressed on or after prior platinum-based chemotherapy and who require additional systemic therapy to treat recurrent or metastatic disease. A Notice of Compliance was recommended.

 

Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations