Date: 2017-12-13
Type of information: Granting of a Market Authorisation in the EU
Product name: Oncaspar®
Compound: pegaspargase - pegylated L-asparaginase
Therapeutic area: Cancer - Oncology
Action mechanism:
- enzyme/antineoplastic agent. Oncaspar® (pegaspargase) is composed of E. coli derived L-asparaginase, which is synthetically modified by covalently conjugating units of monomethoxypolyethylene glycol (PEG) to the enzyme. The mechanism of action of Oncaspar® is based on selective killing of leukemic cells due to depletion of plasma asparagine. Normal cells, however, are less affected by the depletion due to their ability to synthesize asparagine. It is given to patients with ALL as part of a multi-agent chemotherapeutic treatment regimen.
Company: Baxalta (USA - IL) now Shire (UK - USA)
Disease: acute lymphoblastic leukaemia (ALL)
Latest news:
- • On December 13, 2017, Shire announced that the European Commission granted Marketing Authorization for lyophilized Oncaspar® (pegaspargase), as a component of antineoplastic combination therapy in acute lymphoblastic leukemia (ALL) in pediatric patients from birth to 18 years, and in adult patients. The approval authorizes Shire to market lyophilized Oncaspar® in the 28 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway.
- The new lyophilized formulation offers the same dosing regimen as liquid Oncaspar®, but with a three-times longer shelf life than the liquid formulation. Shire expects lyophilized Oncaspar® to be available in European markets beginning in the first half of 2018.
- • On October 12, 2017, the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization for lyophilized Oncaspar® (pegaspargase), as a component of antineoplastic combination therapy in acute lymphoblastic leukemia in pediatric patients from birth to 18 years, and in adult patients. Lyophilized Oncaspar® is a freeze-dried formulation of Oncaspar®. The liquid form of Oncaspar® is currently approved for the same indication.
- • On January 19, 2016, Baxalta announced that the European Commission has granted Marketing Authorization for use of Oncaspar® as a combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients. Baxalta is now authorized to market Oncaspar® in the 28 member countries of the European Union (EU), as well as Iceland , Liechtenstein and Norway . The drug is already licensed to market in Argentina , Belarus , Germany , Kazakhstan , Poland , Russia , Ukraine and the United States
- • On 19 November 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Oncaspar®, intended for the treatment of acute lymphoblastic leukaemia. In Europe, Oncaspar® was authorised in 1994 in Germany and in 2008 in Poland for the treatment of patients with acute lymphoblastic leukaemia who were hypersensitive to native forms of asparaginase.
Oncaspar® will be available as a 750 U/ml solution for injection or infusion. Pegaspargase is obtained by PEGylation of the asparaginase enzyme. Consequent to the complete asparagine depletion in serum, the benefit with Oncaspar® administered as part of combination chemotherapy is its ability to increase the proportion of patients who have complete remission at the end of the treatment period. Oncaspar® has shown to be effective when administered to patients non-hypersensitive to native forms of asparaginase as well as patients previously treated and hypersensitive to native forms of asparaginase. The most common side effects are hypersensitivity including anaphylactic reaction, febrile neutropenia, anaemia, hyperglycaemia, decreased platelet count, decreased neutrophil count and increased blood bilirubin.
- • On July 10, 2014, Sigma Tau Pharma announced the submission of an application to the European Medicines Agency (EMA) for use of its pegylated L-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. With the submission to the EMA, Sigma-Tau Rare Disease aims at making the product equally available in all European Union states.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE: 2014-07-10
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2006-07-24
UE authorization: 2016-01-19/2017-12-13
Favourable opinion UE: 2015-11-19
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
- • In May 2015, Baxter International has signed a definitive agreement to acquire the Oncaspar® (pegaspargase) product portfolio from Sigma-Tau Finanziaria.
- • On July 24, 2006, the FDA granted approval to pegaspargase (Oncaspar®, made by Enzon Pharmaceuticals, Inc.) for the first-line treatment of patients with acute lymphoblastic leukemia (ALL) as a component of a multi-agent chemotherapy regimen. Pegaspargase was previously approved in February 1994 for the treatment of patients with ALL who were hypersensitive to native forms of L-asparaginase. Sigma Tau group gained this product with the acquisition of Enzon's specialty pharmaceutical business in 2009 for $300 million plus an additional amount of up to $27 million based on success milestones. Enzon’s specialty pharmaceutical business also included three other marketed products, Adagen®, DepoCyt®, and Abelcet®, as well as the manufacturing facility in Indianapolis, Indiana.
Is general: Yes
