The U.S. Food and Drug Administration (FDA) has accepted Shire’s Biologics License Application (BLA) for Calaspargase Pegol (Cal-PEG; SHP663). The investigational-stage compound is being reviewed as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2018 for Cal-PEG.

 

Shire is developing SHP663 based on more than a decade of data, research and experience with ONCASPAR^® (pegaspargase), which is approved in the United States as a first-line treatment for patients with ALL. The mechanism of action of ONCASPAR is thought to be based on selective killing of leukemic cells due to the depletion of plasma asparagine, an amino acid that certain tumor cells depend on for growth and development. If approved, Cal-PEG could provide a treatment that has an extended shelf life beyond that of the current PEGylated asparaginase treatment, helping ensure availability to patients.

 

“Today’s FDA acceptance of the Cal-PEG BLA is an important milestone as we work to help address the unmet needs for rare and underserved cancers,” said Andreas Busch, Ph.D., head of Research and Development at Shire. “Developing Cal-PEG underscores our commitment to evolving the standard of care in ALL, including taking innovative steps to improve treatment options for patients.”  

 

The BLA filing is supported by data obtained in ALL patients treated with calaspargase pegol first-line as a component of a multi-agent chemotherapeutic regimen.