EC approves Lilly’s Alimta


The EC has approved Eli Lilly’s Alimta (pemetrexed for injection) as continuation maintenance therapy in patients with nonsquamous non-small cell lung cancer (NSCLC).

Alimta is the first chemotherapy to be approved in Europe for continuation maintenance therapy, for NSCLC patients who have shown a positive response or disease stabilisation following treatment with first-line Alimta plus cisplatin.

Allen Melemed, Senior Medical Director at Lilly Oncology, said: “Tailored therapies have come to the forefront of cancer treatment because they allow clinicians to select the right treatment for the right patient.”

The European approval was based on results from PARAMOUNT, a randomised double-blind Phase III study of 939 patients with advanced nonsquamous NSCLC.

The study showed that Alimta continuation maintenance therapy improved progression-free survival, as well as overall survival, after Alimta-cisplatin first-line therapy.

Alimta is approved in Europe and the US for three indications in patients with advanced nonsquamous NSCLC, including first-line treatment in combination with cisplatin, second-line treatment, and maintenance treatment of patients whose disease has not progressed immediately following platinum-based chemotherapy.

The drug is also approved for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma in the EU and US.

Lung cancer is the most common form of cancer in the world, causing 1.3 million cancer deaths every year. Approximately 85-90% of all lung cancers are NSCLC.

Alimta was recommended by CHMP as continuation maintenance therapy for patients with advanced nonsquamous NSCLC in September 2011 and by NICE for use by the NHS in September 2009.