Puma catches fifth approval, hunts new indication for Nerlynx

Two positive developments for Puma Biotechnology this week have lifted hopes for the potential of the firm’s sole product, the breast cancer therapy Nerlynx (neratinib).

As well as picking up its first approval in Latin America, the therapy has been granted Orphan Drug designation from the US Food and Drug Administration for the treatment of breast cancer patients with brain metastases.

While Nerlynx  won approval in the USA for extended adjuvant treatment of HER2-positive early-stage breast cancer in 2017, it  was initially rejected in Europe, amid a mixed view of its risk-benefit profile. The European Medicines Agency finally  gave the nod in late 2018.