Basilea’s Zevtera Receives the US FDA’s Approval for Staphylococcus aureus Bloodstream Infections
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- Merus’ petosemtamab has received the US FDA’s BTD for treating recurrent or metastatic HNSCC who has been progressed post Pt-based CT and anti-PD-1/PD-L1 treatment. It has also received FTD for the same in Aug 2023. A P-III study in previously treated HNSCC is planned in mid-2024 along with a P-III trial of petosemtamab + Keytruda in treatment-naïve patients
- The designation was based on the ongoing P-I/II assessing the efficacy, durability and safety of petosemtamab alone for treating advanced solid tumors incl. recurrent or metastatic HNSCC. The data is anticipated in H2’24
- Petosemtamab is a Biclonics low-fucose human full-length IgG1 antibody that targets EGFR and LGR5 as well as exhibits 3 independent MOAs such as EGFR-dependent signal inhibition, LGR5 binding leading to EGFR internalization and cancer cells degradation along with enhanced ADCC & ADCP activities
Ref: Basilea | Image: Basilea
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
