Regeneron Pharmaceuticals, Inc. — Libtayo FDA Review (NDA/BLA 761097, 2024)
Regeneron Pharmaceuticals, Inc. · 2024 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Regeneron's Libtayo (cemiplimab-rwlc) on November 10, 2020, for metastatic or locally advanced cutaneous squamous cell carcinoma. This report details its safety profile, clinical trial efficacy (Studies 1540 and 1423), mechanism of action, and pharmacokinetics. Key aspects include objective response rates and duration of response. A significant focus was placed on harmonizing labeling for immune-mediated adverse reactions (imARs) across all PD1/L1 blocking antibodies, including Libtayo. This involved extensive revisions to dosage modifications, warnings, and precautions to ensure consistent, clear guidance for managing these potentially serious side effects. The prescribing information, including these safety-related labeling changes, was deemed acceptable by the FDA after multiple rounds of discussion with Regeneron.
Key findings — cited to the page
| Grade 3 hypophysitis incidence | 0.2 % | LIBTAYO (cemiplimab-rwlc) · p.14 |
| Grade 2 hypothyroidism incidence | 6 % | LIBTAYO (cemiplimab-rwlc) · p.15 |
| Grade 4 immune-mediated hepatitis incidence | 0.2 % | LIBTAYO (cemiplimab-rwlc) · p.14 |
| Grade 2 adrenal insufficiency incidence | 0.3 % | LIBTAYO (cemiplimab-rwlc) · p.14 |
| Grade 2 hyperthyroidism incidence | 0.5 % | LIBTAYO (cemiplimab-rwlc) · p.15 |
| Grade 3 hypothyroidism incidence | 0.2 % | LIBTAYO (cemiplimab-rwlc) · p.15 |
| Grade 3 immune-mediated colitis incidence | 0.3 % | LIBTAYO (cemiplimab-rwlc) · p.14 |
| Grade 2 immune-mediated colitis incidence | 0.7 % | LIBTAYO (cemiplimab-rwlc) · p.14 |
| Grade 3 immune-mediated hepatitis incidence | 1.5 % | LIBTAYO (cemiplimab-rwlc) · p.14 |
| Grade 3 adrenal insufficiency incidence | 0.2 % | LIBTAYO (cemiplimab-rwlc) · p.14 |
| Grade 3 hyperthyroidism incidence | 0.2 % | LIBTAYO (cemiplimab-rwlc) · p.15 |
| Grade 4 Type 1 diabetes mellitus incidence | 0.5 % | LIBTAYO (cemiplimab-rwlc) · p.15 |
Source: Regeneron Pharmaceuticals, Inc. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →