FDA accepts BLA for leukemia drug Cal-PEG

The US Food and Drug Administration has accepted the Biologics License Application (BLA) for calaspargase pegol (Cal-PEG; SHP663), a newer formulation of asparaginase, which has been submitted for approval by Ireland-headquartered Shire (LSE: SHP).

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. Currently, asparaginase is approved in Europe and marketed as Oncaspar (pegaspargase). The drug came into Shire’s portfolio with its $32 billion acquisition of US firm Baxalta in January 2016.

In the realm of therapy for this form of leukemia, asparaginase isn't exactly the sexiest ticket today, says Zach Hartman writing on the Seeking Alpha blog. That would be the CAR-T cells or other immunotherapeutic strategies, he noted. However, asparaginases form an important cornerstone for the treatment of acute leukemia, and its use is being better recognized in the USA for non-pediatric patients. So a novel formulation of the drug that helps to circumvent issues relating to dosing and resistance. Oncaspar nets some $100 million in sales in Europe, so it is likely to give a big boost to Shire if approved in the USA, as well, Dr Hartman opines, adding that, overall, this is a favorable sign for the company, “but is just one piece of a big puzzle for it.”