FDA advisory committee narrowly backs Eli Lilly's Cyramza combo for metastatic EGFR+ NSCLC

Eli Lilly’s Cyramza (ramucirumab) has edged closer to US approval after it scored a recommendation from the FDA’s Oncologic Drugs Advisory Committee (ODAC).

The committee voted 6 to 5 in favour of authorizing the VEGF receptor 2 agonist in the first-line treatment of adults with metastatic non-small cell lung cancer with activating EGFR mutations, when administered in combination with the EGFR-targeting tyrosine kinase inhibitor (TKI) erlotinib.

Phase 3 data submitted in support of the application indicated that the Cyramza combo demonstrated a median progression-free survival benefit of 19.4 months compared to 12.4 months with erlotinib alone, while the safety profiles of the two drugs were inline with previous studies.

"Given the unmet need that remains in treating metastatic EGFR-mutated non-small cell lung cancer, we are encouraged that the majority of these experts agree Cyramza plus erlotinib has a favourable benefit/risk profile for the first-line treatment of these patients," remarked Dr Maura Dickler, Vice President of Late Phase Development at Lilly Oncology. "We believe in the clinical meaningfulness of the data from the RELAY trial, which targeted the VEGFR and EGFR pathways together. We look forward to continuing to work with the FDA on this application to offer a new front-line treatment option for people with metastatic EGFR-mutated non-small cell lung cancer."

While the FDA is not beholden to the ODAC’s ruling, traditionally positive recommendations are a strong indicator of eventual approval of a drug product. The drug combo was approved in the same indication in Europe last month.

Matt Fellows