The Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration voted unanimously for accelerated approval of Alimta® (pemetrexed) in the treatment of non-small cell lung cancer. The indication for accelerated approval allows agents to be marketed early for life-threatening illnesses, based on positive findings in clinical trials. The governing body of ODAC makes recommendations to the FDA regarding approvals or status indications of agents, which are taken into account and tend to be followed by FDA ruling.

Lung cancer remains the leading cause of death among men and women in the United States, with approximately 174,000 individuals diagnosed with lung cancer annually. Non-small cell lung cancer (NSCLC) is a specific type of lung cancer, and refers to the type of cell within the lung that the cancer originated. NSCLC accounts for approximately 80% of all lung cancers in the U.S. Patients diagnosed with NSCLC are often treated with chemotherapy as part of their therapeutic regimen. Initial treatment is referred to as first-line therapy. Unfortunately, a large portion of patients with NSCLC who receive first-line therapy, particularly those with advanced disease, ultimately experience cancer progression and go on to receive further treatment, referred to as second-line therapy. The standard chemotherapy agent for second-line NSCLC is Taxotere® (docetaxel).

Alimta® is a chemotherapy agent that is currently approved in combination with the chemotherapy agent cisplatin (Platinol®) for the treatment of malignant mesothelioma. Alimta® is also currently being evaluated in clinical trials for various types of cancer. The recent approval from ODAC for Alimta® was based upon a large clinical trial that directly compared Taxotere® to Alimta® as second-line therapy in patients with advanced NSCLC. This trial included patients who had a cancer recurrence following intitial treatment for NSCLC, and half were treated with Alimta®, while the other half were treated with Taxotere®. Overall survival and anti-cancer responses were similar betweent the two groups of patients, while those treated with Alimta® suffered from fewer severe side effects. Overall survival was 8.3 months for those treated with Alimta®, compared with 7.9 months for those treated with Taxotere®. Anti-cancer responses were achieved in 9.1% of patients treated with Alimta®, compared with 8.8% of patients treated wth Taxotere®. Patients treated with Alimta® suffered from less severe low levels of white blood cells, infection, diarrhea, hair loss and hospitalization from side effects of treatment.

Patients with recurrent NSCLC may wish to speak with their physician about the risks and benefits of participation in a clinical trial further evaluating Alitma®.

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Reference: Eli Lilly and Company. Alimta® Receives Positive Endorsement for Lung Cancer Approval from FDA Advisory Committee. Available at: http://newsroom.lilly.com/news/Product/2004-7-27_alimta_odac_positively_endorsed.html. Accessed July 2004.

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