EC Approves T-DXd Monotherapy in HR+, HER2-Low/Ultralow Breast Cancer
Results from the phase 3 DESTINY-Breast06 trial demonstrated that T-DXd monotherapy improved PFS over chemotherapy in patients with breast cancer.
EU’s CHMP Recommends Approving Perioperative Nivolumab Combo in NSCLC
Data from the phase 3 CheckMate 77T trial support the CHMP’s opinion on approving the perioperative nivolumab regimen for those with resectable NSCLC.
EU’s CHMP Has Positive Opinion for Subcutaneous Nivolumab in Solid Tumors
Data from the phase 3 CheckMate-67T trial support the CHMP’s recommendation for approving subcutaneous nivolumab across various solid tumor indications.
CHMP Grants Positive Opinion to Tislelizumab/Chemo in Front-Line ES-SCLC
Tislelizumab plus chemotherapy demonstrated superior OS, PFS, ORR, and DOR results compared with placebo plus chemotherapy in first-line ES-SCLC.
CHMP Recommends Acalabrutinib Combo Approval in Untreated MCL
Results from the phase 3 ECHO trial showed PFS and OS improvements with acalabrutinib in the first-line treatment of MCL compared with standard of care.
Tisotumab Vedotin Earns Japanese Approval in Advanced Cervical Cancer
Tisotumab vedotin elicited a median OS of 11.5 months vs 9.5 months with chemotherapy in advanced cervical cancer in the phase 3 innovaTV 301 trial.
EC Approves Nivolumab/Ipilimumab in Frontline Unresectable HCC
The CheckMate 9DW trial found that nivolumab and ipilimumab elicited a median OS of 23.7 months compared with 20.6 months from lenvatinib or sorafenib.
Daratumumab Combo Receives EU CHMP Recommendation in NDMM
Daratumumab would become the sole anti-CD38 agent available for all newly diagnosed multiple myeloma types if approved.
CHMP Recommends T-DXd EU Approval in HER2-Low/Ultralow Breast Cancer
Data from the DESTINY-Breast06 trial support the positive opinion on trastuzumab deruxtecan as a treatment in HER2-low or HER2-ultralow breast cancer.
CHMP Recommends Pirtobrutinib for EU Approval in Pretreated R/R CLL
Pirtobrutinib demonstrated PFS benefit compared with standard of care in patients with relapsed or refractory CLL in the BRUIN CLL-321 trial.
CHMP Recommends EU Approval for Glofitamab Combination in R/R DLBCL
Data from the phase 3 STARGLO study support the CHMP’s recommendation for approving glofitamab plus gemcitabine/oxaliplatin in relapsed/refractory DLBCL.
CHMP Recommends Linvoseltamab for Approval in Heavily Pretreated R/R Multiple Myeloma
Despite prior relapses, 200 mg of linvoseltamab elicited complete responses or better in 49.6% of patients with relapsed/refractory multiple myeloma.
Isatuximab/VRd in Transplant-Ineligible, Newly Diagnosed MM Approved in Japan
Isatuximab plus bortezomib, lenalidomide, and dexamethasone demonstrated enhanced MRD-negativity rates and a PFS benefit in patients with newly diagnosed multiple myeloma.
Belzutifan Receives European Approval in Localized/Advanced RCC Indications
LITESPARK-004 and LITESPARK-005 trial results support the approval of belzutifan in patients with associated localized or advanced clear cell RCC.
CHMP Recommends EU Approval for Durvalumab in Limited-Stage SCLC
Support for the recommendation is based on phase 3 ADRIATIC trial results showing a 27% reduction in the risk of death with durvalumab vs placebo.
Nivolumab Combo Earns Positive CHMP Opinion in Advanced Liver Cancer
Findings from the CheckMate 9DW trial support the CHMP’s recommendation for approving nivolumab/ipilimumab for those with unresectable HCC.
CHMP Recommends Liso-cel in Pretreated R/R Follicular Lymphoma for Approval
The TRANSCEND FL trial showed that liso-cel elicited an ORR of 97.1% and a complete response rate of 94.2% in patients with follicular lymphoma.
Isatuximab Combo Approved in EU for Transplant-Ineligible NDMM
Patients who received the isatuximab combination in the IMROZ trial experienced prolonged MRD-negativity, which correlated with improved PFS.
Dostarlimab Combo Earns Expanded European Approval in Endometrial Cancer
Dostarlimab/chemotherapy elicited a 31% decrease in the risk of death compared with placebo/chemotherapy in locally advanced/recurrent endometrial cancer.
Isatuximab Combo Earns Chinese Approval in R/R Multiple Myeloma
Additionally, the Chinese Society of Clinical Oncology and Chinese Anti-Cancer Association guidelines recommend the isatuximab regimen for this population.
Enfortumab Vedotin Combo Approved in China for Advanced Bladder Cancer
The approved combination of enfortumab vedotin and pembrolizumab provides an alternative to chemotherapy for patients in China.
Savolitinib Combo Earns Priority Review in China for EGFR+ NSCLC
Findings from the phase 3 SACHI trial support the National Medical Products Administration’s priority review designation for savolitinib/osimertinib.
Taletrectinib Gains Chinese Approval for Advanced ROS1-Positive NSCLC
The decision is supported by results from the phase 2 TRUST-1 trial, which evaluated the safety and efficacy of taletrectinib in ROS1-positive NSCLC.
Datopotamab Deruxtecan EU Application Is Voluntarily Withdrawn for NSCLC
Feedback from the European Medicines Agency following results of the phase 3 TROPION-Lung01 informed the marketing authorization application withdrawal.
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.