FDA Accepts BLA for Calaspargase Pegol in Acute Lymphoblastic Leukemia

On February 28, Shire announced that the U.S. Food and Drug Administration (FDA) accepted the company’s biologics license application (BLA) for calaspargase pegol (Cal-PEG; SHP663). The investigational-stage compound is being reviewed as a component of a multiagent 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 calaspargase pegol.

Shire is developing calaspargase pegol based on more than a decade of data, research, and experience with pegaspargase (Oncaspar), which is approved in the United States as a first-line treatment for patients with ALL. The mechanism of action of pegaspargase 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. Asparagine depletion remains a cornerstone of ALL treatment regimens.

Calaspargase pegol is also thought to be based on plasma L-asparagine depletion. The totality of the clinical trial data submitted to the FDA for review, as part of the BLA, included a comparable safety profile and efficacy outcomes to pegaspargase. If approved, calaspargase pegol could provide a treatment that has an extended shelf life beyond that of the current PEGylated asparaginase treatment, helping ensure availability to patients.

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

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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