Shots:The EC has approved label extension to SC Rybrevant (Q1W x 4wks, then Q2W) + Lazcluze for 1L advanced NSCLC harboring EGFRm exon 19 del/ exon 21 L858R substitution & as monotx. for NSCLC pts with EGFRm exon 20 insertions unresponsive to Pt-based CTApproval was backed by P-III (PALOMA-3) trial, evaluating non-inferiority of…
Shots:J&J reported P-III (MARIPOSA) trial data assessing Rybrevant + Lazcluze vs osimertinib or Lazcluze alone as a 1L treatment of locally advanced or metastatic NSCLC pts (n=1074) with EGFR ex19del or L858R substitution mutationsAt 37.8mos. mFU, trial showed superior OS, with mOS not reached vs 36.7mos. for osimertinib-treated pts, plus 56% vs 44%…
Shots: The EC has approved Rybrevant + Lazcluze as a 1L treatment of advanced NSCLC harboring EGFR exon 19 deletions (ex19del) or exon 21 L858R substitution mutations. The EC’s decision of lazertinib for the corresponding combination regimen is pending (was granted CHMP’s recommendation last month) Approval was based on P-III (MARIPOSA) trial assessing Rybrevant +…
Shots: The CHMP has recommended Rybrevant + Lazcluze as a 1L treatment of NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations and approval of Type II extension of indication for amivantamab Opinion was based on the P-III (MARIPOSA) study assessing Rybrevant + Lazcluze vs osimertinib & Lazcluze in NSCLC patients…
Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of August 2024 The US FDA has approved a total of 7 new drugs including 4 new molecular entities and 3 biologics leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was Johnson & Johnson’s Rybrevant plus Lazcluze…

