ELI LILLY CO — Portrazza FDA Summary Review (NDA/BLA 125547, 2015)
Eli Lilly and Company · 2015 · FDA Summary Review (Drugs@FDA) · company profile →
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The FDA summary review for Portrazza (necitumumab) concerns its use for first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC). The pivotal SQUIRE trial demonstrated a statistically significant, albeit modest, improvement in overall survival and progression-free survival when necitumumab was combined with chemotherapy compared to chemotherapy alone. However, a separate trial, INSPIRE, investigating necitumumab in non-squamous NSCLC, was terminated early due to safety concerns, particularly thromboembolic events, and showed no efficacy benefit. Key safety concerns identified for necitumumab include increased cardiopulmonary arrest, hypomagnesemia, and venous/arterial thromboembolic events. Despite these safety concerns, the modest efficacy benefit in squamous NSCLC from the SQUIRE trial led to a recommendation for approval.
Key findings — cited to the page
| Grade 3 or higher venous thromboembolic events | 5 % | · p.16 |
| Grade 3 or higher rash incidence | 4 % | · p.16 |
| Grade 3 or higher vomiting incidence | 3 % | · p.16 |
| Grade 3-4 skin toxicity | 8 % | SQUIRE trial · p.17 |
| incidence of ≥ Grade 3 ATE (comparator) | 2 % | · p.17 |
| dermatologic toxicity (any grade) | 79 % | SQUIRE trial · p.17 |
| incidence of ≥ Grade 3 VTE | 5 % | · p.17 |
| incidence of ≥ Grade 3 VTE (comparator) | 3 % | · p.17 |
| hypomagnesemia Grade 3-4 severity | 20 % | · p.17 |
| hypomagnesemia Grade 3-4 severity (comparator) | 7 % | · p.17 |
| incidence of ≥ Grade 3 ATE | 4 % | · p.17 |
| Grade 3 infusion reactions | 0.4 % | · p.17 |
Source: Eli Lilly and Company ↗ · 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 →