Zanidatamab Receives EU Conditional Marketing Authorization in HER2+ BTC
Data from the HERIZON-BTC-01 trial evaluating zanidatamab in previously treated, unresectable HER2-positive biliary tract cancer support the decision.
Serplulimab Earns UK Approval in Extensive-Stage Small Cell Lung Cancer
Data from the phase 3 ASTRUM-005 trial support the MHRA’s approval of serplulimab for patients with extensive-stage small cell lung cancer.
Cabozantinib Earns CHMP Recommendation in Pancreatic Neuroendocrine Tumors
Data from the phase 3 CABINET trial support the CHMP’s positive opinion of cabozantinib in well-differentiated extrapancreatic or pancreatic NETs.
Nirogacestat Receives Positive Opinion from CHMP in Desmoid Tumors
Results from the phase 3 DeFi trial showed superior progression-free survival with nirogacestat vs placebo in patients with progressing desmoid tumors.
China’s CDE Accepts Marketing Application for Pimicotinib in TGCT
In the phase 3 MANEUVER trial, pimicotinib improved the objective response rate vs placebo in patients with tenosynovial giant cell tumor.
EC Approves Brentuximab Vedotin Combo in Late-Stage Hodgkin Lymphoma
In patients with advanced Hodgkin lymphoma, BrECADD was noninferior to eBEACOPP chemotherapy and demonstrated improved progression-free survival.
CHMP Recommends Approval of Belantamab Mafodotin Combos in Multiple Myeloma
The European Commission is expected to approve the belantamab mafodotin combinations for this multiple myeloma population in the third quarter of 2025.
CHMP Recommends Mirdametinib for EU Approval in Adult/Pediatric NF1-PN
The EMA’s CHMP has adopted a positive opinion for mirdametinib in patients with inoperable plexiform neurofibromas of neurofibromatosis type 1.
Obe-Cel Receives Positive CHMP Opinion for R/R B-Cell ALL
The positive CHMP opinion is based on results from the phase 1b/2 FELIX trial evaluating obe-cel in relapsed/refractory B-cell ALL.
China’s NMPA Approves Tafasitamab/Lenalidomide in ASCT-Ineligible DLBCL
Tafasitamab is the first CD19 antibody approved in China for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma.
Perioperative Nivolumab Combo Earns EU Approval in PD-L1+ Resectable NSCLC
Findings from the CheckMate 77T study support the approval of this nivolumab-based regimen in the European Union.
Belantamab Mafodotin Earns Japanese Approval in R/R Multiple Myeloma
Data from the DREAMM-7 and DREAMM-8 trials support the approval of belantamab mafodotin for patients with relapsed/refractory multiple myeloma in Japan.
Acalabrutinib Combo Receives EU Approval for Mantle Cell Lymphoma
Support for the decision follows a positive opinion from the Committee for Medicinal Products for Human Use based on the phase 3 ECHO trial results.
Linvoseltamab Receives EU Approval for Relapsed/Refractory Multiple Myeloma
The EU approval was based on results from the phase 1/2 LINKER-MM1 trial assessing the efficacy of linvoseltamab in relapsed/refractory multiple myeloma.
CHMP Recommends Brentuximab Vedotin/Chemo in Advanced Hodgkin Lymphoma
Results from the phase 3 HD21 trial showed that brentuximab vedotin plus chemotherapy was superior to alternative treatments in Hodgkin lymphoma.
TTFields Therapy Earns EU Approval in Metastatic Non–Small Cell Lung Cancer
Data from the phase 3 LUNAR trial support the Conformité Européenne Mark for tumor treating fields in metastatic non–small cell lung cancer.
UK’s MHRA Approves Belantamab Mafodotin/Chemo in Myeloma Indications
Results from the DREAMM-7 and DREAMM-8 trials support the approval of belantamab mafodotin with chemotherapy in relapsed/refractory multiple myeloma.
Daratumumab Combo Earns EU Approval in Newly Diagnosed Multiple Myeloma
Data from the phase 3 CEPHEUS trial support the European Commission’s approval of the daratumumab-based regimen.
EC Approves T-DXd Monotherapy in HR+, HER2-Low/Ultralow Breast Cancer
Results from the phase 3 DESTINY-Breast06 trial demonstrated that trastuzumab deruxtecan (T-DXd) monotherapy improved progression-free survival 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/Chemotherapy in Frontline 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.
![“These results and the lack of systemic toxicity observed with [TTFields] provide patients with a promising new treatment option,” according to Joachim Aerts, MD, an investigator of the phase 3 LUNAR trial (NCT02973789).](/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fcancernetwork%2F7d7dfad7849391f4be3ebd2cf39c24f5369cfcd1-1200x1176.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 "“These results and the lack of systemic toxicity observed with [TTFields] provide patients with a promising new treatment option,” according to Joachim Aerts, MD, an investigator of the phase 3 LUNAR trial (NCT02973789).")
