Policy & Regulation
Eli Lilly and Company wins recommendation for FDA approval of CYRAMZA plus erlotinib for NSCLC
27 February 2020 -

Healthcare company Eli Lilly and Company (NYSE:LLY) said on Wednesday that a US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended approval of CYRAMZA (ramucirumab) plus erlotinib for patients with untreated metastatic EGFR-positive non-small cell lung cancer (NSCLC).

The committee voted 6-5 that CYRAMZA plus erlotinib demonstrated a favourable benefit/risk profile for this patient group, based on the results of the positive Phase 3 RELAY study.

RELAY is a global randomised, double-blind, placebo-controlled Phase 3 study of CYRAMZA in combination with erlotinib, compared to placebo in combination with erlotinib, as a first-line treatment in previously untreated patients with metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 substitution mutations.

In the RELAY study, the company randomised 449 patients across North America, Europe and Asia. The primary endpoint of the RELAY trial is progression-free survival (PFS).

CYRAMZA is an antiangiogenic therapy. It is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that binds specifically to VEGFR-2, thereby blocking the binding of the receptor ligands, which may slow tumour growth. The drug inhibited angiogenesis (the process of making new blood vessels) in an in vivo animal model.

Additionally, Lilly has made regulatory submissions outside the United States based on the RELAY data. In January 2020, the European Commission granted European Union approval for CYRAMZA in combination with erlotinib for the first-line treatment of adult patients with metastatic NSCLC with activating EGFR mutations. Lilly has also submitted in Japan and expects regulatory action in the second half of 2020.

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