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FDA Approves Longer-Acting Calaspargase Pegol-mknl for ALL

Gina Columbus @ginacolumbusonc
Published: Friday, Dec 21, 2018

blood cellsThe FDA has approved a longer-acting version of calaspargase pegol-mknl (Asparlas) as a component of a multiagent chemotherapy regimen for pediatric and young adult patients aged 1 month to 21 years with acute lymphoblastic leukemia (ALL).

The new product is designed to provide a longer interval between doses compared with other available pegaspargase products. Calaspargase pegol-mknl contains an asparagine specific enzyme derived from Escherichia coli, as a conjugate of L-asparaginase and monomethoxypolyethylene glycol (mPEG), along with a succinimidyl carbonate (SC) linker. The SC linker is a chemically stable carbamate bond between the mPEG moiety and the lysine groups of L-asparaginase.

The enzyme L-asparaginase catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. Calaspargase pegol-mknl is thought to initiate selective killing of leukemic cells due to depletion of plasma L-asparagine. As leukemic cells with low expression of asparagine synthetase have a reduced ability to synthesize L-asparagine, they rely on an exogenous source of L-asparagine for survival.

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