Following the positive report by CHMP, Lilly has also filed for approval of ‘pemetrexed’ in the same indication with the FDA.
In the European Union and US, pemetrexed is already approved, in combination with cisplatin, as a first-line treatment for locally advanced or metastatic nonsquamous NSCLC for patients. It is indicated as a single agent for the second line treatment of patients with locally advanced or metastatic nonsquamous NSCLC after prior chemotherapy.
Richard Gaynor, Vice President of Cancer Research and Global Oncology platform leader for Lilly, said: This recommendation from the CHMP is encouraging and it brings us one step closer to offering a tailored treatment option that can potentially extend lives for non-small cell lung cancer patients with nonsquamous histology.