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
U.S. FDA Accepts for Priority Review Supplemental NDA for the Use of Trifluridine/Tipiracil (LONSURF®) in Combination With Bevacizumab for Refractory mCRC April 27, 2023
Enrollment completes in Part A of the DeFianCe Study of DKN-01 for the Treatment of Colorectal Cancer Patients April 20, 2023
KEYTRUDA + Chemo Significantly Improved OS Compared to Chemo Alone in Patients With Advanced or Unresectable Biliary Tract Cancer April 20, 2023
Tecentriq + Avastin reduced the risk of cancer returning in people with adjuvant HCC at high risk of disease recurrence following liver resection in Ph 3 IMbrave050 study April 20, 2023
FDA Accepts Application for KEYTRUDA + Chemo as 1L Treatment for Locally Advanced Unresectable or Metastatic Gastric or GEJ Adenocarcinoma April 20, 2023
FAILED TRIALS: Ph 3 LEAP-003 trial of KEYTRUDA + LENVIMA in 1L metastatic melanoma to be discontinued; combo’s Ph 3 LEAP-017 trial in 1L pMMR mCRC didn’t meet primary endpoint of OS improvement April 12, 2023
Omega Enters Supply Agreement With Roche To Evaluate OTX-2002 – Atezolizumab combination in HCC April 6, 2023
First Patient Dosed in ONSEMBLE Ph 2 Randomized Trial of Onvansertib in Patients with mCRC April 6, 2023
Ph 3 interim data analysis of RenovoGem therapy for pancreatic cancer patients to be announced April 6, 2023
