U.S. and EU Regulatory Filings for Neoadjuvant Opdivo and Chemotherapy Followed by Surgery and Adjuvant Opdivo in Resectable NSCLC accepted February 26, 2024
Ph 2 Portion of ALKOVE-1 Trial for Patients with ALK+ve NSCLC and other Solid Tumors initiated February 26, 2024
Dragonfly Announces Clinical Collaboration Exploring Combinations of DF1001 HER-2 TriNKET® with Trodelvy® in two Cancer Indications February 26, 2024
Datopotamab deruxtecan BLA accepted in the US for patients with previously treated advanced nonsquamous non-small cell lung cancer February 26, 2024
Positive EU CHMP Opinion for KEYTRUDA in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy as Adjuvant Treatment, for the Treatment of Resectable NSCLC at High Risk of Recurrence February 26, 2024
FAILED TRIAL: Ph 3 EVOKE-01 study did not meet primary endpoint of OS in previously treated metastatic NSCLC January 31, 2024
Fast Track Designation for Combination of Avutometinib and Sotorasib for the Treatment of KRAS G12C-Mutant NSCLC January 23, 2024
European Commission approves Tecentriq SC, the EU’s first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types January 23, 2024
Clinical Response Update on AFM24-102 Trial in EGFR-wildtype Non-Small Cell Lung Cancer Provided January 17, 2024
European Commission Approves KRAZATI (adagrasib) for Patients with Advanced NSCLC with a KRASG12C Mutation January 17, 2024
FDA Issued New Postmarketing Requirement on Supplemental NDA seeking full approval of LUMAKRAS® (sotorasib) January 10, 2024
FAILED TRIAL: CARMEN-LC03 trial did not meet dual primary endpoint of improving PFS; tusamitamab ravtansine clinical development program to be discontinued January 4, 2024
Supplemental BLA and NDA submitted for RYBREVANT® (amivantamab-vmjw) + Lazertinib for the Treatment of Patients with EGFR-Mutated NSCLC January 4, 2024
Patritumab Deruxtecan Granted Priority Review in the U.S. for Certain Patients with Previously Treated Locally Advanced or Metastatic EGFR-Mutated NSCLC January 4, 2024
SystImmune and Bristol Myers Squibb Announce a Global Strategic Collaboration Agreement for the Development and Commercialization of BL-B01D1 December 19, 2023
Ph 3 INTerpath-002 Study of V940 (mRNA-4157) – KEYTRUDA combination for Adjuvant Treatment of Patients with Certain Types of Resected NSCLC December 19, 2023
Application submitted to the EMA for RYBREVANT + Chemo for the Treatment of Adult Patients with Advanced EGFR-Mutated NSCLC After Failure of Prior Therapy December 11, 2023
KEYLYNK-008 Trial of KEYTRUDA + LYNPARZA for Patients With Metastatic Squamous NSCLC to Stop for Futility December 11, 2023
Interim Data Presented from Two Ongoing Ph 2 Trials with Vebreltinib in NSCLC Patients with MetExon14 Skipping Mutation December 11, 2023
Findings from Ph 2 KeyVibe-002 Trial of Coformulation of Vibostolimab and Pembrolizumab in Previously Treated Patients with mNSCLC Announced December 11, 2023