Lilly can expect a shorter review process in the US for its gastric cancer prospect ramucirumab after regulators granted it priority status.
The designation applies to treatment candidates that have demonstrated significant improvements in the treatment, diagnosis or prevention of serious conditions, and means the US Food Drug and Administration (FDA) will aim to make a decision on the use of ramucirumab within six months rather than the standard 10 months.
The FDA is reviewing the drug, formerly known as IMC-1121B, as a monotherapy for the treatment of patients with advanced gastric cancer following disease progression after initial chemotherapy.
Few therapeutic options exist for this difficult-to-treat condition and, if approved, ramucirumab would be the first drug available in the US in this indication.
The FDA will analyse data from the REGARD trial, which demonstrated that ramucirumab improved both overall survival and progress-free survival in patients with metastatic gastric and gastroesophageal cancers compared to placebo when given as a second-line therapy.
Lilly is also investigating the drug in other indications, including as a combination treatment with paclitaxel for the treatment of advanced gastric cancer, data for which has been positive.
The company expects top-line results next year from phase III trials investigating the drug’s use in colorectal, liver and lung cancer. However, Lilly pulled development in breast cancer after disappointing phase III data.
Revenues up for third quarter
The update on ramucirumab came the same day that Lilly posted its financial results for the third quarter of 2013.
Top-line results reported by Lilly indicate that the company is weathering generic competition for off-patent products, with total revenues for the period growing 6 per cent to $5.77bn.
Despite this, net income for period was down by 9 per cent, although this was mainly due to a special payment of $787m from Amylin regarding Byetta/Bydureon (exenatide) in 2012.
Disregarding this payment and other one-off factors, net income for Lilly was up 35 per cent to $1.2bn.
For its year-to-date results, Lilly posted total revenues of $17.3bn and net income of $3.96bn.
Going forward, the company’s CEO Dr John Lechleiter was confident Lilly’s restructuring plans, which include the cull of one third of its sales reps, will ultimately prove beneficial.
“We are successfully executing our strategy which will enable us to return to growth after 2014 by bringing to the market new medicines that make a real difference for patients,” he said.