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FDA reviewing Shire's enzyme replacement for ALL

February 28, 2018 7:04 PM UTC

Shire plc (LSE:SHP; NASDAQ:SHPG) said FDA accepted for review its BLA for calaspargase pegol (Cal-PEG; SHP663) as part of a multi-agent chemotherapeutic regimen to treat acute lymphoblastic leukemia in a first-line setting. Its PDUFA date is Dec. 22.

The therapy is pegylated L-asparaginase. Shire believes Cal-PEG could have a longer shelf life than Oncaspar pegaspargase, another pegylated L-asparaginase which Shire already markets as a first-line treatment for ALL. The company said existing data show Cal-PEG's efficacy and safety profile is similar to Oncaspar's...

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