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Talactoferrin Alpha receives fast-track designation for the treatment of non-small cell lung cancer.

Oral talactoferrin alfa (TLF) has been granted fast-track designation from the U.S. Food and Drug Administration (FDA) for the clinical development of first-line non-small cell lung cancer (NSCLC) treatment.

The FDA fast-track designation for oral TLF is based on randomized, placebo-controlled, phase II results in patients with NSCLC. Results presented at the American Society of Clinical Oncology's 2006 Annual Meeting (Wang et al., 2006) showed that patients with advanced NSCLC (stage IIIB or IV) receiving standard first-line chemotherapy--carboplatin and paclitaxel plus TLF--showed a substantial improvement in response rate (confirmed response by computed tomography scan using response evaluation criteria in solid tumors) from 29% to 47%. The median progression-free survival improved by 2.8 months.

TLF is a recombinant form of human lactoferrin, an immunomodulatory protein. According to Agennix, the drug's manufacturer, TLF has a unique mechanism of action where the protein acts by binding to specific receptors on target cells and inducing the production of key immunomodulatory cytokines and chemokines. The U.S. standard of care for patients with unresectable NSCLC is a combination of two chemotherapeutic agents: paclitaxel and carboplatin. Even with first-line chemotherapy and some second- and third-line drugs, however, the five-year survival rate for patients is less than 3%.

The FDA's recent fast-track designation has been granted for the clinical development of TLF in combination with first-line chemotherapy. A special protocol assessment from the FDA is being sought for a large phase III trial in NSCLC that is expected to begin in the first half of 2007.

Wang, Y., Raghunadharao, D., Raman, G., Doval, D., Advani, S., Julka, P., et al. (2006). Adding oral talactoferrin to first-line NSCLC chemotherapy safely enhanced efficacy in a randomized trial [Abstract 7095]. Journal of Clinical Oncology, 24(18S), 387.

Chemotherapy Is Equally Effective Up to 12 Weeks After Surgery for Early-Stage Breast Cancer

Waiting up to three months after surgery to begin chemotherapy does not increase recurrence or decrease survival rate in women with early-stage breast cancer, but delaying treatment beyond three months increases the risk of recurrence and death, according to a recent Canadian study.

Looking at the medical records of 2,594 patients receiving chemotherapy for stage I and II breast cancer, researchers compared the relapse-free survival and overall survival among patients grouped by time from surgery to start of chemotherapy. The relapse-free survival and overall survival times were similar for women starting chemotherapy up to 12 weeks after surgery.

According to the researchers, the results should allow women newly diagnosed with breast cancer to take time before starting chemotherapy to consider their options and be involved in treatment decisions, steps that have been shown to reduce anxiety and depression associated with the disease.

Lohrisch, C., Paltiel, C., Gelmon, K., Speers, C., Taylor, S., Barnett, J., et al. (2006). Impact on survival time from definitive surgery to initiation of adjuvant chemotherapy for early-stage breast cancer. Journal of Clinical Oncology, 24, 4888-4894.

Deborah McBride, RN, MSN, CPON[R], Contributing Editor

RELATED ARTICLE: Benefits of Fast-Track Designation.

Fast-track designation is a process designed to expedite the review of drugs intended to treat serious diseases with unmet medical needs. The benefits of fast-track designation include

* Scheduled meetings to seek FDA input into development plans

* The option of submitting a new drug application in sections rather than all components simultaneously

* The option of requesting evaluation of studies using surrogate endpoints.

Fast-track designation also emphasizes close early communication between the FDA and the sponsoring organization to improve the efficiency of product development. Fast-track status adds to existing FDA programs, such as priority review and accelerated approval, that expedite the study and approval of promising new drugs.
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Author:McBride, Deborah
Publication:ONS Connect
Geographic Code:1USA
Date:Jan 1, 2007
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