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: The company's Rybrevant + CT (carboplatin & pemetrexed) has gained the CHMP’s positive opinion as a 1L therapy for NSCLC associated with activating EGFR exon 20 insertion mutations The opinion was based on the P-III (PAPILLON) trial assessing the safety & efficacy of Rybrevant + CT vs CT in NSCLC patients (n=308) with EGFR…
In an interview with PharmaShots, Mark Wildgust, VP of Global Medical Affairs, Oncology at Janssen, Dr. Paolo Ghia, Division of Experimental Oncology at Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele and Paul Barr, Associate Professor of Medicine and Director of the Clinical Trials Office for the Wilmot Cancer Institute at University of Rochester…
In a recent interview with PharmaShots, Kiran Patel, Vice President Clinical Development, Solid Tumor Franchise at Janssen shared his views on the regulatory submission of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.Shots:Janssen reported the BLA submission to the US FDA seeking approval of Amivantamab for the…

