Eli Lilly: Alimta Receives US Green Light for Lung Cancer

Alimta has received US approval for use as a first-line therapy in locally advanced and metastatic non-small cell lung cancer in combination with cisplatin. This third FDA approval for Alimta follows its prominent use in patients with non-squamous carcinoma cell histology and highlights the shift towards a more tailored approach for lung cancer therapy.

Alimta (pemetrexed) received US approval as a first-line therapy for locally advanced and metastatic non-small cell lung cancer (NSCLC) following results from a randomized Phase III trial. In this study, Alimta plus cisplatin was compared against Eli Lilly’s Gemzar (gemcitabine) plus cisplatin in 1,725 patients. Median survival for both arms was 10.3 months and median progression-free survival was 4.8 and 5.1 months for the Alimta-arm and Gemzar-arm, respectively. Alimta was associated with a more favorable toxicity profile with fewer hematological toxicities and fewer blood transfusions required. Alimta previously received EU approval for the same indication in April 2008.

NSCLC is defined as a group of histologies, where tumor types can be differentiated by cellular structure. The major histological types are squamous carcinoma (around 30% of all cases) and adenocarcinoma and large cell carcinoma, which together make up non-squamous cell carcinoma (around 60%). Interestingly, overall survival according to NSCLC cell histology was also evaluated in the Phase III study and clinically relevant differences were seen. For patients with non-squamous cell carcinoma NSCLC, median survival was higher in the Alimta-arm, 11.0 versus 10.1 months for Gemzar. Conversely, for patients with squamous cell carcinoma NSCLC, median survival was higher in the Gemzar-arm at 10.8 versus 9.4 months for Alimta.

In 2004, Alimta was approved in the US for use in unresectable malignant pleural mesothelioma patients in combination with cisplatin. At the same time, Alimta was approved in the US for use as a single-agent for second-line advanced or metastatic NSCLC patients although the FDA has now changed this to include non-squamous patients only.

Alimta is now likely to compete with Avastin and other cisplatin-based regimens in the first-line setting. Currently, Avastin (bevacizumab; Genentech/Roche) is approved and extensively used in the US (October 2006) and EU (August 2007) in combination with chemotherapy (carboplatin and paclitaxel). In the UK however, the National Institute for Health and Clinical Excellence (NICE) recommended against the use of Avastin and Alimta for NSCLC for National Health Service (NHS) patients on the grounds of low cost-effectiveness. Nevertheless, Alimta’s tolerability and ease of administration will help significantly boost its sales as it gains a greater foothold in NSCLC market in the US as well as the rest of the EU.