Knight Therapeutics’ Nerlynx (neratinib) Receives Health Canada Approval as Extended Adjuvant Therapy for HR+ and HER2+ Breast Cancer

https://www.pharmashots.com/press-releases/puma-biotechnologys-licensing-partner-knight-therapeutics-receives-regulatory-approval-from-health-canada-to-commercialize-nerlynx-neratinib-for-extended-adjuvant-treatment-of-hormone-recep/

Shots:

  • The marketing authorization is based on P-III ExteNET study results assessing Nerlynx following adjuvant trastuzumab therapy vs PBO in 2,840 patients with early-stage HER2-positive breast cancer within two of completing trastuzumab-based adjuvant therapy
  • The P-III ExteNET study resulted in a 51% reduction in risk of diseases recurrence in patients @2yrs. with invasive disease-free survival as (95.3% vs 90.8%)
  • Nerlynx is a kinase inhibitor and its oral formulation has received FDA’s approval and EMA’s approval in Jul’2017 and Sept’2018 respectively. Knight Therapeutics granted global rights to develop & commercialize neratinib as PB272 (oral), PB272(IV) and PB357 to Puma Biotechnology

 Click here to read full press release/ article | Ref: Puma Biotechnology | Image: LinkedIn