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

 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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

Related post