FDA advisory panel narrowly backs use of Eli Lilly's Cyramza for untreated metastatic EGFR-mutated NSCLC

Eli Lilly announced that an FDA advisory committee narrowly voted in favour of the use of Cyramza (ramucirumab), in combination with Astellas and Roche's Tarceva (erlotinib), for patients with untreated metastatic EGFR-positive non-small-cell lung cancer (NSCLC). The panel voted 6-5 that the VEGFR-2 antagonist demonstrated a favourable benefit/risk profile in this indication, based on results of the Phase III RELAY study.

The company reported last year that the trial met its primary endpoint of progression-free survival (PFS), with results later published in The Lancet Oncology showing that median PFS was 19.4 months in the Cyramza plus Tarceva arm versus 12.4 months for the placebo plus Tarceva arm. Meanwhile, the most common grade 3 or higher adverse events that occurred more frequently among Cyramza-treated patients in the study were hypertension, dermatitis acneiform and diarrhoea.

"Given the unmet need that remains in treating metastatic EGFR-mutated NSCLC, we are encouraged that the majority of these experts agree Cyramza plus [Tarceva] has a favourable benefit/risk profile for the first-line treatment of these patients," said Maura Dickler, vice president of late-phase development at Lilly Oncology.

In January, the European Commission approved Cyramza in combination with Tarceva for the first-line treatment of adults with metastatic NSCLC with activating EGFR mutations. Eli Lilly has also submitted a filing in Japan based on findings from the RELAY trial, with a decision on the application expected in the second half of 2020.

Cyramza, which is also authorised in gastric cancer, colorectal cancer and hepatocellular carcinoma, generated sales of $245.1 million in the fourth quarter of 2019, up 11% on the prior-year period.

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