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09-10-2018 | EMA | News


Brigatinib, paclitaxel, biosimilar pegfilgrastims receive EMA approvals

medwireNews: The latest meeting of the EMA’s Committee for Medicinal Products for Human Use has made decisions on the use of brigatinib, paclitaxel, and biosimilar formulations of pegfilgrastim in patients with cancer.

The anaplastic lymphoma kinase (ALK) inhibitor brigatinib has received a positive opinion for marketing authorization for use in adults with advanced ALK-positive non-small-cell lung cancer who have previously been treated with the ALK inhibitor crizotinib. Brigatinib has also recently been approved for use in this population by the US FDA.


Paclitaxel has also been granted a positive opinion for marketing authorisation. The taxane may be given in combination with carboplatin to patients with a first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.


Three biosimilar formulations of pegfilgrastim received positive recommendations for supportive care use in patients undergoing chemotherapy. Fulphila (Mylan SAS, Saint-Priest, France), Pelmeg (Cinfa Biotech SL, Pamplona, Spain) and Ziextenzo (Sandoz International GmbH, Holzkirchen, Germany) may be used to reduce both the duration of neutropenia and the likelihood of febrile neutropenia in this population.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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