FDA OKs Merrimack’s Cancer Drug

The US Food and Drug Administration has approved Merrimack Pharmaceuticals’ Onivyde (irinotecan liposome injection) in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.

Baxalta Incorporated is responsible for the development and commercialization of Onivyde outside of the United States and Taiwan under the exclusive licensing agreement that Merrimack and Baxalta entered into in September 2014. In May 2015, the European Medicines Agency accepted for review Baxalta’s marketing authorization application (MAA) for Onivyde based on the same clinical results.

PharmaEngine, Inc. (Taipei, Taiwan) holds the rights to commercialize Onivyde in Taiwan. PharmaEngine filed a new drug application with the Taiwan FDA in May 2015.

Source: Merrimack Pharmceuticals

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