Sep 29 2004
Biomira and Merck KGaA have announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track status to the investigation of BLP25 Liposome Vaccine (L-BLP25) for its proposed use in the treatment of non-small cell lung cancer (NSCLC).
The FDA's Fast Track programs are designed to facilitate the development and expedite review of drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. With Fast Track designation, there may be more frequent interactions with the FDA during the development of a product and eventually a company may be eligible to file a U.S. biologics license application (BLA) on a rolling basis as data becomes available. This permits the FDA to review a filing as it is received, rather than waiting for the entire document prior to commencing the review process. Due to the nature of these types of products, BLAs filed with Fast Track status are generally eligible for priority review, which could decrease the typical review period.
Biomira submitted a Fast Track application to the FDA, which included encouraging results from a controlled, randomized Phase IIb study in Stage IIIB and IV NSCLC patients. Results from the Phase IIb study will be presented at the European Society of Medical Oncology meeting (ESMO) to be held in Vienna, Austria, on November 1.
A recent letter received from the FDA stated, "We have reviewed your request and concluded that it meets the criteria for the Fast Track designation. Therefore, we are designating as a Fast Track Drug Product development program the investigation of Liposomal Vaccine in the extension of survival among patients with unresectable stage 3a and locoregional stage 3b non-small cell lung cancer following first line chemotherapy. We look forward to working with you to expedite the development and review of this promising proposed use of the product."
"Fast Track designation for L-BLP25 for the treatment of these patients is an important step in the development of this product candidate and may help us bring this potentially promising drug to patients more quickly," said Alex McPherson, MD, PhD, President and CEO of Biomira. "This is a significant milestone for the Company, highlighting the importance of product candidates such as L-BLP25 to one day address a sizeable unmet need in this patient population. We believe our vaccine will be able to provide a new treatment option for men and women with NSCLC that has the potential to both extend and improve the quality of their lives."
L-BLP25 is a synthetic MUC1 peptide vaccine, designed to induce an immune response to cancer cells. L-BLP25 incorporates a 25-amino acid sequence of the MUC1 cancer mucin, encapsulated in a liposomal delivery system. The liposome enhances recognition of the cancer antigen by the immune system and facilitates better delivery.
Biomira and Merck KGaA continue to explore opportunities for early registration for this product candidate with other regulatory agencies. Plans are also underway for a confirmatory Phase III study.