Supplemental BLA submitted to FDA for RYBREVANT® (amivantamab-vmjw) + Chemo for 1L EGFR Exon 20 Insertion Mutation-Positive mNSCLC September 6, 2023
Application For Lumakras® (Sotorasib) For The Treatment Of KRAS G12C-Positive NSCLC To be Discussed At FDA Advisory Committee Meeting September 6, 2023
REZILIENT3 Global First-Line Trial of Zipalertinib Launched in Patients With NSCLC Harboring EGFR Exon 20 Insertion Mutations August 9, 2023
Retevmo® (selpercatinib) Demonstrated Superior PFS vs a PD-1 Inhibitor + Chemo for Adults with Newly-Diagnosed Advanced or Metastatic RET Fusion-Positive NSCLC August 9, 2023
Treatment with RYBREVANT® (amivantamab-vmjw) + Chemo Resulted in Statistically Significant PFS Improvement in Patients with 1L EGFR Ex 20 Ins Mutation-Positive NSCLC July 27, 2023
EMA provides negative Review in the European Union of KRAZATI (adagrasib) for the Treatment of Advanced NSCLC with a KRAS G12C Mutation July 27, 2023
Updates on DCR in the Part A safety lead-in of THIO-101 phase 2 trial of THIO + cemiplimab in patients with advanced NSCLC announced July 19, 2023
FDA granted Fast Track Designation for REQORSA® Immunogene Therapy for patients with extensive-stage small cell lung cancer (ES-SCLC) July 19, 2023
FDA clears FDA INDA for CFT8919, an Orally Bioavailable BiDAC™ Degrader Targeting EGFR L858R for Non-Small Cell Lung Cancer July 19, 2023
Regulatory and Clinical Updates for TIL Therapy in Advanced NSCLC provided; positive FDA Feedback Supports IOV-LUN-202 Trial Design for Accelerated Approval of TIL Therapy in Post-Anti-PD-1 Advanced NSCLC July 19, 2023
Datopotamab Deruxtecan Met Dual Primary Endpoint Of PFS In Patients With Advanced NSCLC in TROPION-Lung01 Phase 3 Trial July 12, 2023
FDA Clears Investigational New Drug Application for CFT8919 Targeting EGFR L858R for Non-Small Cell Lung Cancer July 11, 2023
First patient dosed in Ph 2 MATISSE study in combination with durvalumab and chemotherapy in treatment-naïve patients with resectable early stage NSCLC July 5, 2023
Phase 3 Study of Tifcemalimab plus Toripalimab for Treatment of Limited-stage Small Cell Lung Cancer initiated July 5, 2023
Datopotamab deruxtecan met dual primary endpoint of PFS in patients with advanced NSCLC in TROPION-Lung01 Phase III trial July 5, 2023
U.S. FDA grants Fast Track Designation to REQORSA® in Combination with Tecentriq® for the Treatment of Small Cell Lung Cancer July 5, 2023
GAVRETO® (pralsetinib) Supplemental NDA approval by China NMPA for first-line treatment of patients with locally advanced or metastatic RET fusion-positive NSCLC July 5, 2023
505(b)(2) NDA Approval granted from FDA for PEMRYDI RTU®, a Ready-to-Use Oncology Injectable June 21, 2023
Impact Therapeutics Entered into Global Partnership with Eikon Therapeutics to Develop and Commercialize PARP1 Selective Inhibitors June 6, 2023
C4 Therapeutics and Betta Pharmaceuticals Announce Exclusive Licensing Agreement for the Development and Commercialization in Greater China of CFT8919 June 6, 2023
