ALL – media

New Formulation of ONCASPAR®▼ (pegaspargase) Receives Marketing Authorization in Europe for Patients with Acute Lymphoblastic Leukemia (ALL)

Shire plc (LSE: SHP, NASDAQ: SHPG), the global leader in rare diseases, today announced that the European Commission (EC) 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.1 The approval – which authorizes Shire to market lyophilized ONCASPAR in the 28 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway – follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on October 12.
- Source: Shire
- 606
- December 15, 2017
ALL Antineoplastic New Approvals
US regulators wave through Pfizer’s leukaemia drug

Pfizer’s Besponsa has been approved by the US Food and Drug Administration (FDA). It's the first and only CD22-directed antibody-drug conjugate indicated to treat relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
- Source: pharmatimes
- 1,043
- August 21, 2017
ALL antibody Company Insight FDA New Approvals

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