Lilly gains new stomach cancer approval for Cyramza

The FDA has said Lilly's new stomach cancer drug Cyramza can be given alongside paclitaxel, extending its earlier approval as a monotherapy.

Cyramza (ramucirumab) was approved in April as a single-use agent for people with advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose disease had progressed despite earlier chemotherapy, becoming the first drug licensed in the US for that indication.

The extension of its license to include combination treatment with paclitaxel is based on the results of a phase III trial - called RAINBOW - which showed a statistically significant improvement in median overall survival when Cyramza was added to paclitaxel therapy.

Patients on the combination had a median survival benefit of 9.6 months, compared to 7.4 months for patients on the placebo plus paclitaxel arm, and there were also significant improvements in progression-free survival (PFS) and the objective tumour response rate.

Cyramza was launched by Lilly in the second quarter of this year and racked up sales of $28m in the third quarter, which Lilly chief executive John Lechleiter said was a strong start for the product.

The drug - which is a vascular endothelial growth factor (VEGF) receptor 2 antagonist and blocks blood vessel formation in tumours - is considered one of Lilly's top pipeline prospects and has been predicted to make sales in excess of $1.5bn a year at peak.

Lilly has now reported four phase III trials in which Cyramza has improved overall survival, including two in second-line gastric cancer therapy, one in second line non-small cell lung cancer (NSCLC) - which earned it a priority review from the FDA - and another in second-line metastatic colorectal cancer. It proved ineffective however in a study involving liver cancer patients which was reported in June.

Susan Mahoney, president of Lilly Oncology, said recently she was anticipating a possible approval in lung cancer by the end of the year - with a launch in that indication early in 2015 - as well as approval in colorectal cancer in the following months.

The latest approval for Cyramza is also a boost to Dyax, which was involved in its discovery and earns a 5% royalty on net sales.

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