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Oncaspar filed with EU for ALL-Sigma Tau Pharma

Read time: 1 mins
Last updated:11th Jul 2014
Published:11th Jul 2014
Source: Pharmawand

Sigma Tau Pharma has announced the submission of an application to the European Medicines Agency (EMA) for use of its pegylatedL-asparaginase, Oncaspar (pegaspargase) for the treatment of Acute Lymphoblastic Leukaemia (ALL) as part of a multi-agent chemotherapeutic regimen.

The submission is based on extensive clinical data generated from a sponsored clinical development program and independent investigator-initiated trials, carried on both in Europe and the United States.The drug is already approved in several countries including the United States, Germany, Poland, Russia, and Argentina.

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