IND Filing for PFL-002/VERT-002 for Patients with Solid Tumors Including NSCLC with MET Alterations June 11, 2024
FDA grants Fast Track Designation for Combination Therapy of AFM24 with Atezolizumab for EGFR WT NSCLC June 4, 2024
FAILED TRIAL: Datopotamab deruxtecan showed clinically meaningful OS improvement vs. chemo in patients with advanced nonsquamous NSCLC in TROPION-Lung01 Ph 3 trial May 29, 2024
NMPA of China Accepted and Granted Priority Review Designation to the NDA for Glecirasib May 29, 2024
U.S. FDA Accepts and grants Priority Review of BLA for Zeno for the Treatment of NRG1+ NSCLC and PDAC May 15, 2024
Belrestotug + dostarlimab exceeded pre-defined efficacy criteria for clinically relevant activity observed in interim assessment of Ph 2 GALAXIES Lung-201 May 15, 2024
FAILED TRIAL: Ph 3 CheckMate -73L trial did not meet primary endpoint of PFS in unresectable, locally advanced stage III NSCLC May 14, 2024
Positive CHMP opinion for RYBREVANT (amivantamab) in combination with chemotherapy for the 1L treatment of patients with advanced NSCLC with activating EGFR exon 20 insertion mutations May 1, 2024
Move-Forward Ph 2 Expansion Dose for IDE397 Monotherapy in MTAP-Deletion Squamous NSCLC selected April 23, 2024
Ph 3 Trial of MK-1084 + KEYTRUDA for 1L Treatment of Certain Patients With Metastatic NSCLC initiated April 9, 2024
FAILED TRIAL: Topline Results of Ph 2 KICKSTART Trial of Tomivosertib + Pembrolizumab in NSCLC announced April 8, 2024
Supplemental NDA for Toripalimab as Perioperative Treatment for Resectable NSCLC Patients approved April 8, 2024
METIS Ph 3 Trial Met Primary Endpoint of Statistically Significant Extension in Time to Intracranial Progression for Patients with Brain Mets from NSCLC April 2, 2024
KRYSTAL-12 Trial of KRAZATI (adagrasib) Meets Primary Endpoint of PFS for Patients with Pretreated KRAS G12C-Mutated NSCLC April 2, 2024
Savolitinib Supplemental NDA Accepted in China for Treatment-Naïve or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC April 2, 2024
European Commission Approves KEYTRUDA + Chemo as Neoadjuvant Treatment, Then Continued as Monotherapy as Adjuvant Treatment, for Resectable NSCLC at High Risk of Recurrence in Adults April 2, 2024
FAILED TRIAL: Ph 3 KEYLYNK-006 trial of KEYTRUDA + maintenance LYNPARZA did not meet dual primary endpoints of OS and PFS in 1L EGFR/ALK/ROS1 WT patients with metastatic nonsquamous NSCLC March 26, 2024
FDA accepts the NDA for ensartinib for the treatment of adult patients with metastatic ALK-positive NSCLC March 19, 2024
Biotheus Expanded Partnership with Hansoh Pharma for Developing EGFR/cMET Bispecific ADCs March 18, 2024