NMPA grants Tislelizumab + chemo approval for 1L use in advanced gastric or gastroesophageal junction adenocarcinoma with high PD-L1 expression February 28, 2023
Enhertu approved in China for patients with HER2-positive metastatic breast cancer treated with one or more prior anti-HER2-based regimens February 28, 2023
UK MHRA grants full Marketing Authorization to NEXPOVIO (selinexor), Velcade, and SVd combo for previously-treated multiple myeloma patients February 22, 2023
US FDA grants regular approval for Jemperli for the treatment of patients with recurrent or advanced mismatch repair-deficient endometrial cancer February 22, 2023
FDA Approves Jaypirca™ (pirtobrutinib) for Adult Patients with R/R Mantle Cell Lymphoma After at Least Two Lines of Systemic Therapy, Including a BTKi February 8, 2023
FDA approves Orserdu (elacestrant) for endocrine therapy-treated postmenopausal women or adult men with ER+ve, HER2-neg, ESR1-mutated advanced or metastatic breast cancer February 8, 2023
FDA Accelerated Approval of TUKYSA® (tucatinib) + Trastuzumab in Previously Treated RAS WT, HER2-Positive mCRC Patients February 1, 2023
FDA Approves KEYTRUDA® as Adjuvant Treatment Following Surgical Resection and Platinum-Based Chemotherapy for Patients With Stage IB, II, or IIIA NSCLC February 1, 2023
Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer February 1, 2023
FDA approved Lunsumio® (mosunetuzumab-axgb) for the treatment of adult patients with R/R follicular lymphoma January 4, 2023
Imfinzi plus chemotherapy approved in the EU as first immunotherapy regimen for patients with advanced biliary tract cancer January 4, 2023
FDA approved Adstiladrin for High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer January 4, 2023
Lynparza + abiraterone approved in the EU in 1L metastatic CRPC based on Ph 3 PROpel trial results January 4, 2023
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
