Puma May Face Marketing Hurdles Even If Neratinib Wins Final Approval

31 May 2017

• By Mark W. Sherman and Sue Sutter

Neratinib's value as extended adjuvant therapy for HER2-positive breast cancer may be diminished if Roche succeeds in altering the standard of care for initial adjuvant treatment, among other challenges.

Breast Cancer Awareness: Microscopic image (photomicrograph) of core biopsy for infiltrating (invasive) ductal carcinoma, detected by screening mammogram. H & E stain.

Puma Biotechnology Inc.'s Nerlynx (neratinib) came through the US FDA's Oncologic Drugs Advisory Committee with a guarded recommendation for approval as extended adjuvant treatment of HER2-positive breast cancer, but even if it is cleared the company faces significant challenges ahead.

Much of the May 24 panel discussion focused on a potential narrowing of the indication, the possibility that the circumstances...