NEW YORK – Puma Biotechnology said on Wednesday that the supplemental new drug application of neratinib (Nerlynx) in combination with chemotherapy capecitabine was approved by the US Food and Drug Administration. The approved indication is for advanced or metastatic HER2-positive breast cancer patients who have received two or more anti-HER2 therapies prior.
The sNDA approval is supported by data from the randomized Phase III NALA trial, which showed that the combination of neratinib and capecitabine reduced the risk of death and the incidence of central nervous metastases compared to tyrosine kinase inhibitor lapatinib (Novartis' Tykerb) and capecitabine. Progression-free survival at 24 months was 12 percent in the neratinib and capecitabine arm compared to 3 percent in the lapatinib and capecitabine arm.
Neratinib was first approved by the FDA in 2017 as an extended adjuvant therapy for patients with early-stage HER2-overexpressed or amplified breast cancer, following adjuvant treatment with chemotherapy trastuzumab.
Neratinib is also approved in Europe, Canada, Australia, Hong Kong, Singapore and Argentina for use in the extended adjuvant setting. Puma expects to seek approval for this second indication in those countries.