Posted by Michael Wonder on 01 Jul 2021
FDA approves dose escalation label update for Puma Biotechnology’s Nerlynx (neratinib) in HER2 positive early stage and metastatic breast cancer
1 June 2021 - Dose escalation of Nerlynx therapy demonstrated improved management and prevention of Grade 3 diarrhoea.
Puma Biotechnology announced that the U.S. FDA approved a labelling supplement to the U.S. Prescribing Information for Nerlynx that incorporates the use of Nerlynx dose escalation as evaluated in the Phase 2 CONTROL Trial and the new 133 count commercial Nerlynx SKU.
