Eli Lilly has been boosted by the news that regulators in the USA have given the thumbs-up for its blockbuster Alimta to be used as a first-line treatment against certain types of non-small cell lung cancer.

Specifically, the US Food and Drug Administration has approved injectable Alimta (pemetrexed), in combination with cisplatin, in the first-line treatment for locally advanced and metastatic NSCLC in patients with non-squamous histology. However the approval does not cover squamous cell NSCLC.

The FDA’s support came on the back of a Phase III trial involving 1,725 patients, which compared Alimta to Lilly’s own Gemzar (gemcitabine), both in combination with cisplatin. The median survival was 10.3 months in both arms of the study.

The median progression-free survival was 4.8 and 5.1 months, and the overall response rates were 27.1% and 24.7% for the Alimta/cisplatin and Gemzar/cisplatin arms, respectively. Patients treated with the Alimta regimen had less haematologic toxicity, fewer blood transfusions and decreased use of growth factors compared to those treated with the Gemzar combo.

The FDA’s latest approval marks the third US indication for Alimta, Lilly notes. In 2004, the drug was given the green light first in combination with cisplatin for patients with malignant pleural mesothelioma, whose disease is unresectable or who are not candidates for curative surgery, and then as a single agent for the second-line treatment of patients with NSCLC after prior chemotherapy treatment.

Alimta is a major earner for Lilly and second-quarter sales increased 33% to $275.0 million. Getting a fresh approval is good news for the firm especially as it comes just three days after the FDA said that it has still not completed a review on the New Drug Application on prasugrel, Lilly and Daiichi Sankyo’s investigational oral antiplatelet drug.