Calquence approved in Japan for adults with treatment-naïve chronic lymphocytic leukaemia January 4, 2023
Imfinzi plus Imjudo approved in Japan for advanced liver and non-small cell lung cancers, and Imfinzi approved for unresectable biliary tract and liver cancers January 4, 2023
Enhertu approved in the EU for patients with previously treated HER2-positive advanced gastric cancer January 4, 2023
U.S. FDA announces Accelerated Approval of KRAZATI™ (adagrasib) for Patients with Locally Advanced or Metastatic NSCLC with a KRASG12C Mutation December 19, 2022
European Commission Approves Pluvicto® For Treatment Of Progressive PSMA+ve metastatic CRPC December 19, 2022
FDA Approves REZLIDHIA™ (olutasidenib) for the Treatment of Adult Patients with R/R AML with a Susceptible IDH1 Mutation December 5, 2022
ENHERTU® Approved in Japan for Patients with Previously Treated HER2 Positive Metastatic Breast Cancer November 30, 2022
FDA grants Accelerated Approval of ELAHERE™ (mirvetuximab soravtansine-gynx) for the Treatment of Platinum-Resistant Ovarian Cancer November 23, 2022
Imfinzi and Imjudo with chemotherapy approved in the US for patients with mNSCLC based on POSEIDON Phase III trial results November 16, 2022
FDA approves cemiplimab (Libtayo) with platinum-based chemotherapy for the treatment of advanced NSCLC patients with WT EGFR, ALK, or ROS1 November 16, 2022
U.S. FDA Approves TECVAYLI (teclistamab-cqyv) for the Treatment of Patients with R/R Multiple Myeloma November 2, 2022
Imjudo (tremelimumab) in combination with Imfinzi approved in the US for patients with unresectable liver cancer based on Ph 3 HIMALAYA trial November 2, 2022
FDA approves first companion diagnostic to identify patients with HER2 low metastatic breast cancer eligible for ENHERTU October 12, 2022
KEYTRUDA® Receives Four New Approvals in Japan, Including in High-Risk Early-Stage TNBC October 5, 2022
FDA approved Lytgobi (futibatinib) for adults with advanced intrahepatic cholangiocarcinoma (iCCA) who have FGFR2 gene fusions or other rearrangements October 5, 2022
FDA Approves Retevmo® (selpercatinib) for Adults with Advanced or Metastatic Solid Tumors with a RET Gene Fusion, Regardless of Type September 28, 2022
European Commission approves Opdualag (nivolumab + relatlimab) for the Treatment of Unresectable or Metastatic Melanoma with Tumor Cell PD-L1 Expression < 1% September 28, 2022
Lynparza approved in China as 1L maintenance treatment with bevacizumab for HRD+ve advanced ovarian cancer September 28, 2022
Imfinzi plus chemotherapy approved in the US as the first immunotherapy regimen for patients with advanced biliary tract cancer September 13, 2022
FDA Approves Pemazyre® (Pemigatinib) For Myeloid/Lymphoid Neoplasms (MLNs) With FGFR1 Rearrangement September 7, 2022
