European Commission Grants Conditional Marketing Authorization for LYTGOBI Tablets for the Treatment of Adults With Cholangiocarcinoma July 11, 2023
Imfinzi + Imjudo demonstrated sustained OS benefit in advanced liver cancer with an unprecedented one in four patients alive at four years in HIMALAYA Ph 3 trial July 5, 2023
Positive Second Interim Efficacy Analysis from Mitazalimab OPTIMIZE-1 Ph 2 Study in 1st Line Pancreatic Cancer Announced July 5, 2023
RenovoGem™ Delays Cancer Progression by Eight Months in Locally Advanced Pancreatic Cancer July 5, 2023
Zenocutuzumab granted Breakthrough Therapy Designation by US FDA for the treatment of NRG1+ pancreatic cancer July 5, 2023
FAILED TRIAL: Ph 3 KEYNOTE-585 Trial in GEJ Adenocarcinoma didn’t meet primary endpoint of EFS June 28, 2023
KEYTRUDA + Trastuzumab and Chemotherapy Met Primary Endpoint of PFS as 1L Treatment in Patients With HER2-Positive Advanced GEJ Adenocarcinoma June 21, 2023
FDA accepts Supplemental NDA for Onivyde regimen in 1L metastatic pancreatic ductal adenocarcinoma June 21, 2023
FDA Accepts Application for KEYTRUDA Plus Chemotherapy as Treatment for Advanced or Unresectable Biliary Tract Cancer June 14, 2023
NDA submitted to Japan’s MHLW for zolbetuximab in 1L CLDN18.2-positive HER2-neg gastric or gastroesophageal junction (mGEJ) adenocarcinoma patients June 14, 2023
FDA Approves FoundationOne®LiquidCDx as a Companion Diagnostic for BRAFTOVI + Cetuximab combo to Identify Patients With BRAF V600E Alterations in mCRC June 14, 2023
Positive Lead-In Data from Ongoing Ph 3 PEAK Trial of Bezuclastinib + Sunitinib in Patients with Gastrointestinal Stromal Tumors (GIST) announced June 6, 2023
IMFINZI + chemo significantly improved pathologic complete response in gastric and gastroesophageal junction cancers in MATTERHORN Ph 3 trial June 6, 2023
Claudin 18.2 Antibody-Drug Conjugate ATG-022 Granted Orphan Drug Designations by the U.S. FDA for the Treatment of Gastric and Pancreatic Cancers May 31, 2023
NDA for Fruquintinib for Treatment of Previously Treated mCRC Granted Priority Review; PDUFA: Nov 2023 May 31, 2023
NMPA Breakthrough Designation for IBI351 (KRASG12C Inhibitor) as Monotherapy for Previously Treated Advanced Colorectal Carcinoma May 18, 2023
European Commission approves Tibsovo® (ivosidenib tablets) in IDH1-mutated Acute Myeloid Leukemia and IDH1-mutated Cholangiocarcinoma May 18, 2023
Early Positive IMX-110 Interim Data shows 100% Tumor Shrinkage in Advanced mCRC at the Lowest Dose of IMX-110 + Tislelizumab May 10, 2023
Positive Early Results from Global Randomized Ph 1b/2 Combination Study of TPST-1120 in 1L HCC announced May 10, 2023
