EC Approves Ribociclib/Aromatase Inhibitor For HR+/HER2– Early Breast Cancer
The European Commission has approved ribociclib plus an aromatase inhibitor for patients with early breast cancer.
Tislelizumab/Chemo Approved by European Commission For ESCC/GEJ
The European Commission has approved tislelizumab plus chemotherapy as treatment for patients with esophageal and gastric or GEJ cancer.
EU Approval Recommended for Repotrectinib in ROS1+ NSCLC, NTRK+ Solid Tumors
Results from the TRIDENT-1 and CARE trials, which showcased durable activity and robust responses with repotrectinib, supported the recommendation.
Nivolumab/Ipilimumab Earns CHMP Recommendation for Colorectal Cancer
The CHMP recommended for approval nivolumab/ipilimumab for patients with MSI-H and dMMR unresectable or metastatic colorectal cancer.
NCCN Expands Genetic Risk Assessment Guidelines to Include Additional Tumor Types
National Comprehensive Cancer Network updated 2 guideline resources to keep providers and other stakeholders up to date on cutting-edge genetic research.
Pembrolizumab Regimens Earn European Approvals in Gynecologic Cancers
Data from KEYNOTE-868 and KEYNOTE-A18 support the approval of pembrolizumab-based therapy in endometrial and cervical cancer, respectively.
Enfortumab Vedotin Combo Earns Japanese Approval for Urothelial Carcinoma
Phase 3 EV-302 results supported the approval, showing a statically significant survival benefit compared with chemotherapy in urothelial carcinoma.
Zolbetuximab Earns European Approval in Advanced CLDN18.2+ Gastric Cancer
Data from the GLOW and SPOTLIGHT trials support the European Commission’s approval of zolbetuximab for patients with CLDN18.2-positive gastric cancer.
Belantamab Mafodotin Combo Regimens Accepted for Review in Japan in R/R MM
A belantamab mafodotin combination regimen has been accepted for review in Japan, based on data from the DREAMM-7 and DREAMM-8 clinical trials.
Encorafenib Combo Earns European Approval in Advanced BRAF+ NSCLC
Data from the phase 2 PHAROS trial support the European Commission’s approval of encorafenib/binimetinib in NSCLC harboring a BRAF V600E mutation.
sNDA of Fruquintinib Combo Withdrawn in China for Second-Line Gastric/GEJ Cancer
Second-line fruquintinib plus paclitaxel did not sustain sufficient efficacy for patients with advanced gastric or GEJ adenocarcinoma to support approval in China.
Enfortumab Vedotin Combo Gains European Approval for Urothelial Cancer
The decision follows phase 3 EV-302 trial findings showing improved survival with enfortumab vedotin plus pembrolizumab vs chemotherapy in urothelial cancer.
European Commission Approves Amivantamab Combo for EGFR-mutated NSCLC
The EGFR-MET bispecific antibody amivantamab in combination with chemotherapy yielded a survival benefit compared with chemotherapy alone for EGFR-mutated NSCLC.
Odronextamab Earns European Approval in R/R Follicular Lymphoma, DLBCL
The European Commission’s decision represents the first regulatory approval of odronextamab for patients with follicular lymphoma or DLBCL.
Fulzerasib Receives Approval in China for Advanced KRAS G12C+ NSCLC
Phase 2 data support the National Medical Products Administration’s approval of fulzerasib for those with KRAS G12C–mutated NSCLC in China.
Epcoritamab Earns EU Approval in Relapsed/Refractory Follicular Lymphoma
Conditional marketing authorization for epcoritamab in the European Union is based on findings from the phase 1/2 EPCORE NHL-1 trial.
EMA Validates Type II Application for Liso-cel in R/R Follicular Lymphoma
In Japan, liso-cel recently received approval for patients with previously treated relapsed/refractory follicular lymphoma.
Durvalumab Combos Receive EU Approval in pMMR/dMMR Endometrial Cancer
Subgroup analysis data from DUO-E support the European approval of durvalumab-based treatment in primary or recurrent endometrial cancer.
China’s NMPA Accepts sNDA for Frontline Toripalimab in Metastatic Melanoma
Data from the phase 3 MELATORCH study support the supplemental new drug application for frontline toripalimab in unresectable or metastatic melanoma.
Zolbetuximab/Chemo Gets Positive EU CHMP Opinion in Advanced Gastric Cancer
Frontline zolbetuximab plus chemotherapy is one step closer to approval by the European Commission for select patients with advanced gastric/GEJ cancer.
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.