Novelos Therapeutics, Inc., a biotechnology company focused on the development of therapeutics to treat cancer and hepatitis, announced that the Food and Drug Administration (FDA) has granted fast track designation to NOV-002 for use in combination with first-line chemotherapy for the treatment of advanced non-small cell lung cancer (NSCLC).
The FDA's fast track programme is designed to facilitate the development and accelerate the review process for new drugs that have the potential to address a serious and unmet medical need for conditions such as advanced NSCLC.
Novelos, under Fast Track, now qualifies for Rolling Review of the NOV-002 New Drug Application (NDA). The rolling NDA saves time by allowing review of NDA subsections by the FDA as they become available, rather than delaying review until all NDA components are submitted together. In addition, Fast Track status results in more frequent meetings and communication with FDA reviewers, strengthening the development program in support of NOV-002 approval. Furthermore, the NOV-002 NDA will be more likely to receive a Priority Review of six months, rather than the standard twelve months.
"Obtaining Fast Track for NOV-002 is a further validation of Novelos' development progress, as we commence a pivotal Phase 3 NSCLC trial under a SPA", said Harry Palmin, president and CEO of Novelos. "It recognizes that Novelos' clinical and non-clinical data demonstrated NOV-002's potential to address significant unmet medical need in advanced lung cancer patients."
Lung cancer is the leading cause of cancer death in the US According to the American Cancer Society, it is expected that in 2006 approximately 175,000 Americans will be diagnosed with lung cancer and more than 160,000 will die as a result. NSCLC accounts for more than 80 per cent of lung cancer. Platinum-based chemotherapy regimens, such as paclitaxel and carboplatin, are standard first-line treatment for advanced NSCLC patients since these patients are not eligible for surgery.
However, the efficacy of currently available treatments is marginal (survival rates of only about 35 per cent at one year after diagnosis and 5% after five years) and they are characterized by a high rate of severe toxicities.
NOV-002 is a small molecule drug based on oxidized glutathione that acts as a chemoprotectant and immunomodulator. Novelos recently finalized a Special Protocol Assessment (SPA) with the FDA for a single pivotal Phase 3 trial in advanced NSCLC for NOV-002 in combination with first-line chemotherapy, and patient enrolment is expected to begin this quarter. In a controlled randomized U.S. Phase 1/2 clinical trial, advanced NSCLC patients treated with NOV-002 in combination with paclitaxel and carboplatin demonstrated improved objective tumour response and higher tolerance of chemotherapy versus the control group. In a controlled randomised Russian trial, when used in combination with cisplatin-based chemotherapy, NOV-002 increased the one-year survival of advanced NSCLC patients from 17 per cent to 63 per cent. NOV-002 has an extensive safety database.