Johnson & Johnson Reports the BLA Submission of SC Amivantamab to the US FDA for Treating Non-Small Cell Lung Cancer
Shots:
- J&J has submitted BLA for the SC combination of amivantamab & recombinant human hyaluronidase (SC amivantamab) to treat all the approved or submitted indications of IV Rybrevant among specific NSCLC patients
- The BLA submission included data from P-III (PALOMA-3) study assessing PK, efficacy & safety of SC vs IV formulation of amivantamab + lazertinib to treat EGFRm advanced or metastatic NSCLC and P-II (PALOMA-2) study supporting Q2W & Q3W dosing schedules
- The PALOMA-3 trial data, highlighted at ASCO 2024 & published in the Journal of Clinical Oncology, showed similar ORR with SC & IV administrations along with shorter administration time, five-fold reduced infusion-related reactions, improved OS, PFS & DoR
Ref: Johnson & Johnson | Image: Johnson & Johnson
Related Post:- Johnson & Johnson Gains the CHMP’s Positive Opinion for Rybrevant (Amivantamab) as a 1L Treatment of NSCLC
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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.
