EMA Validates Application for Nivolumab/Ipilimumab in Liver Cancer Type
Survival results from the phase 3 CheckMate –9DW trial support the application for the combination therapy in treating hepatocellular carcinoma.
EMA Accepts Application for Belantamab Mafodotin in R/R Multiple Myeloma
Data from DREAMM-7 and DREAMM-8 support the marketing authorization application for the belantamab mafodotin combinations in multiple myeloma.
Osimertinib Plus Chemotherapy Gains European Approval for EGFR+ NSCLC
Findings from the phase 3 FLAURA2 trial support the European approval of osimertinib/chemotherapy in EGFR-mutated non–small cell lung cancer.
Durvalumab Regimens Are Recommended for EU Approval for pMMR, dMMR Endometrial Cancer
A statistically significant and clinically meaningful improvement in progression-free survival in the phase 3 trial DUO-E support the recommendation.
EU’s CHMP Recommends Odronextamab Approval in Follicular Lymphoma, DLBCL
Findings from ELM-1 and ELM-2 support the positive opinion for odronextamab as a treatment for relapsed/refractory follicular lymphoma and DLBCL.
EU’s CHMP Recommends Epcoritamab Approval in R/R Follicular Lymphoma
The European Commission is expected to decide on approving epcoritamab in relapsed/refractory follicular lymphoma later in 2024.
Osimertinib/Chemotherapy Attains Japanese Approval in EGFR+ Advanced NSCLC
The approval for osimertinib/chemotherapy by the Japanese Pharmaceuticals and Medical Device Agency was based on results from the phase 3 FLAURA2 trial.
Momelotinib Receives Japanese Approval for Treatment of Myelofibrosis
Approved for use in newly diagnosed and previously treated myelofibrosis, momelotinib may addresses key manifestations of the disease.
European Commission Approves Fruquintinib in Pretreated Metastatic CRC
Data from FRESCO-2 support the approval of fruquintinib for those with previously treated metastatic colorectal cancer in the European Union.
EMA Validates Application for Subcutaneous Nivolumab in Solid Tumors
The European Medicines Agency will begin a centralized review process for subcutaneous nivolumab across multiple solid tumor indications.
Golidocitinib Receives Chinese Approval in Relapsed/Refractory PTCL
Golidocitinib monotherapy had a superior clinical benefit in patients with relapsed/refractory peripheral T-cell lymphoma vs existing treatments.
Capivasertib Combo Earns European Approval in ER+/HER2– Breast Cancer
Data from CAPItello-291 support the approval of capivasertib/fulvestrant for ER-positive, HER2-negative breast cancer in the European Union.
Adjuvant Alectinib Earns European Approval in Resectable ALK+ NSCLC
Data from the phase 3 ALINA trial support the approval of alectinib for patients with ALK-positive non–small cell lung cancer in the European Union.
Nivolumab Combo Receives European Approval in Advanced Urothelial Carcinoma
The CheckMate -901 trial led to the approval of the nivolumab combination for unresectable or metastatic urothelial carcinoma in the European Union.
Nivolumab/Ipilimumab Receive Type II Validation by EMA in MSI-H/dMMR mCRC
CheckMate-8HW assessed the efficacy of first-line nivolumab plus ipilimumab in patients with MSI-H/dMMR metastatic colorectal cancer.
CHMP Promotes Positive Opinion of Amivantamab in EGFR Exon 20+ NSCLC
Amivantamab/chemotherapy has been recommended for approval by the CHMP in advanced non–small cell lung cancer with EGFR exon 20 insertion mutations.
EU’s CHMP Recommends Nivolumab Combo Approval in Urothelial Carcinoma
Findings from the CheckMate-901 trial support the CHMP’s positive opinion of nivolumab plus chemotherapy in metastatic urothelial carcinoma.
European Commission Approves Enzalutamide in nmHSPC Subset
Those with high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer can now receive enzalutamide in the European Union.
European Commission Approves Cilta-cel in R/R Multiple Myeloma
Findings from the phase 3 CARTITUDE-4 trial support the European approval of ciltacabtagene autoleucel for relapsed/refractory multiple myeloma.
Tislelizumab Earns European Approval in Non–Small Cell Lung Cancer
A series of phase 3 findings support the European approval of tislelizumab as a first-line and second-line treatment for non–small cell lung cancer.
Annamycin Earns European Orphan Drug Designation in Acute Myeloid Leukemia
Preliminary findings from the MB-106 trial support the potential benefit of annamycin/cytarabine in patients with acute myeloid leukemia.
Toripalimab Combo Receives Chinese Approval for Advanced RCC
Toripalimab plus axitinib is now an approved regimen in China for patients with medium- to high-risk unresectable or metastatic renal cell carcinoma.
China Accepts sNDA for Savolitinib in Previously Treated MET Exon 14 NSCLC
Data from a phase 3b trial support a supplemental new drug application in China for savolitinib in previously treated non–small cell lung cancer with MET exon 14 alterations.
Luspatercept Earns Expanded European Approval for Anemia in Lower-Risk MDS
Data from the phase 3 COMMANDS trial support the expanded European approval of frontline luspatercept for transfusion-dependent anemia in lower-risk myelodysplastic syndromes.
Ceramic Thyroid Ablation Needle Earns Class III Certificate in China
The characteristics of rare earth ceramics may yield more consistent microwave energy penetration during the treatment of those with thyroid nodules.
Enfortumab Vedotin Combo Earns Priority Review in China for Bladder Cancer
Data from the phase 3 EV-302 trial support an application for enfortumab vedotin plus pembrolizumab as a treatment for patients with advanced bladder cancer in China.
Capivasertib Combo Receives Approval in Japan for HR+/HER2– Breast Cancer
Findings from the phase 3 CAPItello-291 trial support the approval of capivasertib/fulvestrant for patients with hormone receptor–positive, HER2-negative breast cancer in Japan.
Pembrolizumab/Chemo Earns European Approval in Resectable NSCLC
Data from the phase 3 KEYNOTE-671 trial support the European Commission’s approval of pembrolizumab plus chemotherapy for those with resectable non–small cell lung cancer.
EU’s CHMP Recommends Enzalutamide Approval in Non-Metastatic HSPC
The positive opinion is supported by findings from the phase 3 EMBARK trial assessing enzalutamide in patients with biochemically recurrent prostate cancer.
Ide-Cel Earns European Approval in Triple-Class Exposed Multiple Myeloma
Data from the phase 3 KarMMa-3 trial support the approval of idecabtagene vicleucel for relapsed/refractory multiple myeloma in the European Union.