FDA Accepts Supplemental BLA for PADCEV® (enfortumab vedotin-ejfv) + KEYTRUDA for 1L Locally Advanced or Metastatic Urothelial Cancer patients January 4, 2023
Enhertu recommended for approval in the EU by CHMP for patients with HER2-low metastatic breast cancer January 4, 2023
Positive EMA Opinion on Orphan Designation for Ivospemin (SBP-101) + Gemcitabine and Nab-Paclitaxel in Patients with Metastatic Pancreatic Ductal Adenocarcinoma December 19, 2022
PDUFA date extended by three months to review Lynparza + abiraterone & prednisone supplemental NDA for metastatic CRPC December 19, 2022
Application in European Union Seeking Approval of IMBRUVICA (ibrutinib) for the Treatment of Patients with Untreated Mantle Cell Lymphoma withdrawn December 19, 2022
U.S. FDA Breakthrough Therapy Designation Granted for Revumenib for the Treatment of Patients with R/R KMT2A- Rearranged (MLLr) Acute Leukemia December 12, 2022
BLA submitted to U.S. FDA for Talquetamab for the Patients with R/R Multiple Myeloma December 12, 2022
FDA Fast Track Designation to pelareorep + atezolizumab + chemo in Advanced/Metastatic Pancreatic Cancer December 5, 2022
U.S. indication of Tecentriq® for the treatment of cisplatin-ineligible, PD-L1+ve adults with locally advanced or mUC to be withdrawn December 5, 2022
FDA accepts BLA of Denileukin Diftitox for the Treatment of Patients with Persistent or Recurrent Cutaneous T-Cell Lymphoma December 5, 2022
FDA Granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track Designations to CB-010 December 5, 2022
U.S. FDA Accepts for Priority Review the BLA for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of R/R Large B-Cell Lymphoma November 30, 2022
FDA issued CRL indicating the poziotinib application cannot be approved in its present form; company to deprioritise the program November 30, 2022
FDA Clears IND Application for BCMA CAR-T CB-011 for the Treatment of R/R Multiple Myeloma November 30, 2022
Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2-positive advanced gastric cancer November 23, 2022
Lynparza – abiraterone combo recommended for approval in the EU by CHMP in 1L metastatic CRPC November 23, 2022
Imfinzi plus chemotherapy recommended for approval in the EU by CHMP as first immunotherapy regimen for advanced biliary tract cancer November 23, 2022
FDA restricted 2L maintenance indication for Zejula (niraparib) to only the patient population with deleterious or suspected deleterious gBRCAmut November 23, 2022
Innovation Passport Designation granted to Biologic CAR T-Cell Therapy Engager ALETA-001 November 16, 2022
Quizartinib Granted Priority Review in the U.S. for Patients with Newly Diagnosed FLT3-ITD Positive AML November 2, 2022
FDA clears IND for LYL845, a TIL Product Candidate Enhanced with its Novel Epigenetic Reprogramming Technology for Solid Tumors November 2, 2022
