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
BLAs for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of R/R LBCL and DLBCL submitted November 2, 2022
U.S. FDA Accepts For Priority Review Supplemental BLA For Trodelvy® For Pre-Treated HR+/HER2- Metastatic Breast Cancer October 19, 2022
US FDA grants Fast Track Designation for SHP2 inhibitor BBP-398 in Combination with LUMAKRAS® (sotorasib) October 19, 2022
Positive Pre-NDA Meeting for Rivoceranib Combination With Camrelizumab as Hepatocellular Carcinoma Treatment Option Announced October 19, 2022
FDA grants Fast Track Designation for LAG-3 Therapeutic Eftilagimod Alpha for 1L NSCLC October 12, 2022
FDA grants Fast Track Designation for Sapanisertib in NRF2-mutated Squamous Lung Cancer October 12, 2022
Successful End-of-Phase 2 Meeting With the FDA and Preparation for the Registrational Trial of PDS0101 in Combination With KEYTRUDA® October 12, 2022
TUKYSA® (tucatinib) + Trastuzumab combo Granted Priority Review by FDA for Previously Treated HER2+ve Metastatic CRC September 28, 2022
Applications Submitted For Rubraca® Label Expansion In The US And EU As 1L Maintenance Treatment In Advanced Ovarian Cancer Patients September 28, 2022
Positive CHMP Opinion for BRUKINSA® (zanubrutinib) for the Treatment of Adults with MZL September 28, 2022
Yescarta® Gets Positive CHMP Opinion For Use In 2L DLBCL And High-Grade B-Cell Lymphoma September 28, 2022
Oncologic Drugs Advisory Committee to review Zejula overall survival data from the NOVA Ph 3 trial in recurrent ovarian cancer September 28, 2022
