FDA Grants Breakthrough Therapy Designation to Sacituzumab Tirumotecan (sac-TMT) for the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous NSCLC With EGFR Mutations December 10, 2024
FDA Approves BIZENGRI® (zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NRG1+ NSCLC Based on Safety and Efficacy Data From the eNRGy Study December 10, 2024
FAILED TRIAL: Ph 3 SKYSCRAPER-01 study of tiragolumab + Tecentriq in patients with PD-L1-high 1L mNSCLC did not reach the primary endpoint of OS December 4, 2024
Positive CHMP Opinion for Repotrectinib for the Treatment of Advanced ROS1-Positive NSCLC and Advanced NTRK-Positive Solid Tumors November 19, 2024
Datopotamab deruxtecan new BLA submitted for accelerated approval in the US for patients with previously treated advanced EGFR-mutated NSCLC November 19, 2024
CHMP recommends RYBREVANT® (amivantamab) + LAZCLUZE® (lazertinib) for 1L treatment of patients with EGFR-mutated advanced NSCLC November 19, 2024
Tagrisso recommended for approval in the EU by CHMP for patients with unresectable EGFR-mutated lung cancer based on Ph 3 LAURA trial results November 19, 2024
NDA Submitted to the U.S. FDA for Sunvozertinib in Treating R/R NSCLC with EGFR Exon 20 Insertion Mutations November 12, 2024
Ph 3 Trial of Adjuvant V940 (mRNA-4157) + KEYTRUDA After Neoadjuvant KEYTRUDA and Chemotherapy in Patients With Certain Types of NSCLC Initiated November 5, 2024
First Patient Dosed in Ph 1 Clinical Trial Evaluating ZW171 in Advanced Mesothelin-Expressing Cancers November 5, 2024
AKIR001 cleared to start Ph 1 clinical trial in multiple cancer types, including anaplastic and iodine-refractory thyroid cancer, SCCHN, and NSCLC November 5, 2024
Three Ph 3 Trials of Datopotamab Deruxtecan-Based Combinations Initiated in Patients with Advanced Nonsquamous NSCLC November 5, 2024
TAGRISSO + ORPATHYS demonstrated high, clinically meaningful response rate in NSCLC patients with MET overexpression and/or amplification in SAVANNAH Ph2 trial October 22, 2024
First Patient Dosed in Ph 1/2 Trial of PFL-241/STX-241 in Locally Advanced or Metastatic NSCLC patients October 15, 2024
FDA Approves Perioperative Treatment of Neoadjuvant Opdivo and Chemo Followed by Surgery and Adjuvant Single-Agent Opdivo for Resectable NSCLC October 15, 2024
BDTX-1535 program to be advanced into pivotal development based on robust Ph 2 clinical data from EGFRm NSCLC patients October 15, 2024
Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC October 15, 2024
US FDA Approves Perioperative Treatment of Neoadjuvant Opdivo and Chemo Followed by Surgery and Adjuvant Single-Agent Opdivo for Resectable NSCLC October 8, 2024
Preliminary safety data from the Ph 1b portion of the BGBC016 study in 1L NSCLC patients announced October 8, 2024
BLA submitted for accelerated approval for Telisotuzumab Vedotin (Teliso-V) in Previously Treated NSCLC with c-Met protein overexpression based on Ph 2 LUMINOSITY trial (M14-239) data October 2, 2024
Tagrisso approved in the US for patients with unresectable, Stage III EGFR-mutated lung cancer October 2, 2024
