FDA approves Nerlynx sNDA for metastatic HER2-positive breast cancer

The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Nerlynx (neratinib) in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting, submitted by Puma Biotechnology (Nasdaq: PBYI).

The sNDA approval was based on results of the Phase III NALA trial, a randomized controlled trial of neratinib plus capecitabine in patients with HER2-positive metastatic breast cancer who have received two or more prior anti-HER2-based regimens.

“Although there have been many new treatment options for patients with HER2-positive breast cancer, patients still need additional treatment options once they progress” said Alan Auerbach, chief executive and president of Puma, adding: “Based on the results of our NALA data, we believe Nerlynx could be a promising therapeutic opportunity for these patients.”