Puma purrs on FDA's neratinib nod

The USA’s Puma Biotechnology (Nasdaq: PBYI) was up by 8.5% at $93.40 in the opening moments of Tuesday’s trading after the US Food and Drug Administration (FDA) approved Nerlynx (neratinib) for extended adjuvant treatment of HER2-positive early-stage breast cancer.

This makes neratinib the first anti-HER2 treatment to be FDA-approved as extended adjuvant therapy for early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy.

The unmet medical need is significant, as up to 25% of HER2-positive early-stage breast cancer patients treated with trastuzumab-based adjuvant treatment, experience a recurrence.