Eli Lilly is celebrating after regulators in the USA expanded approval on the use of Alimta to include maintenance treatment for advanced lung cancer.

The US Food and Drug Administration has given the green light for Alimta (pemetrexed) to be the first maintenance therapy to be approved for locally advanced or metastatic non-small cell lung cancer. Specifically, the drug can now be used by patients “with a nonsquamous histology whose disease has not progressed after four cycles of platinum-based first-line chemotherapy”, Lilly added.

The expanded approval is based on a Phase III trial involving 663 patients with stage IIIB/IV NSCLC whose disease had not progressed after four cycles of chemotherapy. The data showed that patients with certain subtypes of NSCLC who received Alimta plus best supportive care survived for 15.5 months following treatment, compared with 10.3 months for those on best supportive care alone. However, patients with predominantly squamous-cell NSCLC did not benefit from Alimta, the findings revealed.

The Lilly drug “represents a new approach in the treatment of advanced NSCLC,” said Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Typically, patients whose tumours respond to chemotherapy do not receive further treatment after four-to-six chemotherapy cycles” but “this study demonstrates an advantage in overall survival in certain patients”, he added.

Richard Gaynor, vice president of cancer research and global oncology platform leader for Lilly, said the FDA thumbs-up “represents an important paradigm shift for NSCLC treatment – maintenance therapy as a way of extending survival in nonsquamous patients, using histology as a way of determining which NSCLC patients may benefit and which may not”. Previously, patients received best supportive care following their chemotherapy but “now physicians and patients have a new option to improve survival," he concluded.

This is the fourth approval for Alimta. It is already used in patients with mesothelioma, as well as in first- and second-line settings for the treatment of locally advanced or metastatic NSCLC.

The drug is becoming a big earner for Lilly, and first-quarter sales shot up 36% to $335.3 million. This latest approval is likely to push that figure up even further.