Government allows import of acute lymphoblastic leukemia drug

The government has recently granted import approval for Oncaspar Lyophilized Inj. (ingredient: pegaspargase), a drug for acute lymphoblastic leukemia.

Servier Korea said it obtained the nod from the Ministry of Food and Drug Safety for importing Oncaspar as an orphan drug to be used in combination with other anti-cancer drugs when treating acute lymphocytic leukemia in children and adults under the age of 18.

According to Servier, Oncaspar increased the half-life of drug circulation with pegylation to reduce the frequency of L-asparaginase administration from every other day to once every 14 days.

Considering the high incidence of acute lymphocytic leukemia in pediatric patients, the improved regimen to be administered every 14 days is expected to reduce the patient's burden of injection and physical pain and hypersensitivity reactions caused by injection treatment, Servier said.

The U.S and Germany granted the permit to Oncaspar as the second-line treatment for acute lymphocytic leukemia in 1994.

In 2006, the drug won approval as the first-therapy for all acute lymphocytic leukemia in the U.S. In 2016, it also obtained the license as part of the combination therapy with other anti-cancer drugs to treat acute lymphocytic leukemia patients in Europe.

In Korea, individual patients or guardians have had limited access to Oncaspar through the Korea Orphan & Essential Drug Center.

With the latest import approval, Servier Korea will be able to supply the treatment for acute lymphocytic leukemia patients stably, the company said.