Keeping Track: US FDA Clears Santen’s Omlonti, Fennec’s Pedmark; Lilly’s Retevmo Adds Tumor-Agnostic Claim
Executive Summary
The latest drug approval news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Fennec Finds Ex-US Commercial Partner For Pedmark In UK’s Norgine
Norgine will market Pedmark, indicated to reduce risk of chemotherapy-related hearing loss in pediatric cancer, in the EU and UK. It will seek additional approvals in Australia and New Zealand.
Fennec Prepared For Market As Pedmark Finally Gets FDA Nod
After successive CRLs in 2020 and 2021, the drug gained a broad label for hearing loss in children treated with cisplatin for localized, non-metastatic solid tumors.
Coherus Biosimilar Used ‘Scientific Justification’ To Skip Switch Study, Still Get Interchangeability With Lucentis
Information on mechanism of action, pharmacokinetics, immunogenicity and toxicity convinced the US FDA there was no risk in terms of safety or diminished efficacy of switching between Cimerli and the reference product, Genentech’s eye drug Lucentis.