Eli Lilly bagged an important new indication for its cancer therapy Cyramza after the FDA approved it as a treatment for advanced non-small cell lung cancer (NSCLC).
Cyramza (ramucirumab) – a VEGFR2 antagonist that works by blocking the blood supply that fuels tumour growth – has been cleared for second-line treatment alongside docetaxel use after platinum-based chemotherapy for NSCLC has failed.
The drug is steadily being approved in new indications that are helping build sales momentum, with a go-ahead for second-line treatment of gastric cancer in combination with paclitaxel just a few weeks ago to add to an earlier approval as a monotherapy in this indication.
Meanwhile, positive phase III data as a second-line treatment for metastatic colorectal cancer – in combination with chemotherapy – should form the basis of additional regulatory applications in the first half of 2015.
It has not all been plain sailing, however, and in June Lilly revealed the drug failed to improve survival in patients with hepatocellular carcinoma, a type of liver cancer, having previously flunked a phase III trial in breast cancer.
Cyramza’s approval in metastatic NSCLC is based on the REVEL clinical study of 1,253 patients with previously treated and progressive NSCLC, who were randomly assigned to receive either Cyramza or placebo on top of docetaxel.
Results showed that patients treated with survived an average of 10.5 months from the start of treatment, compared to an average of 9.1 months for patients on placebo, which was a statistically significant improvement.
Progression-free survival (PFS) was also improved with the combination at 4.5 months with Cyramza and 3.0 months with docetaxel plus placebo. The marketing application was granted a priority review by the FDA.
Cyramza is one of a trio of new products at Lilly – along with diabetes therapies Jardiance (empagliflozin) and Trulicity (dulaglutide) – that are driving revenues at the company as it copes with patent expirations for former blockbusters such as antidepressant Cymbalta (duloxetine) and Evista (raloxifene) for osteoporosis.
Lilly acquired Cyramza as part of its $6.5bn takeover of ImClone back in 2008. Analysts at JP Morgan have said that they expect annual sales of the drug to reach $1.35bn by 2020, with the bulk coming from its stomach cancer indications.
Cyramza was launched by Lilly in the second quarter of this year in the US and achieved sales of $28m in the third quarter. The latest approval is also a boost for Dyax, which was involved in its discovery and earns a 5% gross royalty on net sales.