Adjuvant Nivolumab Receives CHMP Recommendation for Completely Resected Stage IIB/C Melanoma
July 21st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of nivolumab monotherapy for the adjuvant treatment of patients at least 12 years of age with completely resected stage IIB or IIC melanoma.
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Epcoritamab Approaches EU Approval for Relapsed/Refractory DLBCL
July 21st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending conditional marketing authorization to epcoritamab monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma after 2 or more lines of systemic therapy.
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FDA Approves Quizartinib Plus Chemotherapy for Newly Diagnosed, FLT3-ITD+ AML
July 20th 2023The FDA has approved quizartinib in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia that is FLT3-ITD positive, as detected by an FDA-approved test.
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APVO436 Plus Venetoclax/Azacitidine Produces Durable Remissions in Relapsed/Refractory AML
July 20th 2023Treatment with the CD3 x CD123 bispecific antibody APVO436 plus venetoclax and azacitidine led to durable remissions in patients with relapsed/refractory acute myeloid leukemia who had not received prior venetoclax.
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China’s NMPA Accepts sNDA for First-Line Toripalimab Plus Chemo in ES-SCLC
July 20th 2023China’s National Medical Products Administration has accepted a supplemental new drug application seeking the approval of toripalimab in combination with platinum-based chemotherapy for the first-line treatment of patients with extensive-stage small cell lung cancer.
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IMX-110 Plus Tislelizumab Leads to Tumor Shrinkage in Heavily Pretreated mCRC
July 19th 2023Treatment with the combination of the tissue-specific therapeutic IMX-110 and the anti–PD-1 antibody tislelizumab led to tumor shrinkage in heavily pretreated patients with metastatic colorectal cancer.
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Setanaxib Plus Pembrolizumab Elicits PFS Benefit in Recurrent or Metastatic HNSCC
July 18th 2023The combination of the NOX1/4 inhibitor setanaxib and pembrolizumab produced progression-free survival benefits compared with placebo plus pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma.
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NOX-A12 Plus Radiotherapy and Bevacizumab Produces Responses in Previously Untreated Glioblastoma
July 17th 2023The addition of the CXCL12 inhibitor NOX-A12 to standard-of-care radiotherapy and bevacizumab elicited responses when used as first-line treatment in patients with glioblastoma, according to updated data from the expansion arm of the phase 1/2 GLORIA trial.
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EMA Accepts Marketing Application for Zolbetuximab in CLDN18.2+ Gastric/GEJ Adenocarcinoma
July 17th 2023The European Medicines Agency has accepted a marketing authorization application seeking the approval of zolbetuximab for first-line treatment of patients with Claudin18.2-positive, HER2-negative, unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
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FDA Accepts NDA for Rivoceranib Plus Camrelizumab in Unresectable HCC
July 17th 2023The FDA has accepted for review a new drug application seeking the approval of rivoceranib in combination with camrelizumab as a first-line treatment option for patients with unresectable hepatocellular carcinoma.
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FLX475 Alters TME to Enhance Anti–PD-1/PD-L1 Response in NK/T-cell Lymphoma
July 13th 2023Single-agent treatment with the novel CCR4 antagonist FLX475 led to changes in the tumor microenvironment to a phenotype more associated with responses to anti–PD-1/PD-L1 therapy in patients with natural killer/T-cell lymphoma.
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China’s NMPA Accepts sNDA for Frontline Toripalimab Plus Axitinib in Metastatic RCC
July 12th 2023China’s National Medical Products Administration has accepted a supplemental new drug application seeking the approval of toripalimab plus for the first-line treatment of patients with unresectable or metastatic renal cell carcinoma
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FDA Accepts sBLA for Zanubrutinib Plus Obinutuzumab for R/R Follicular Lymphoma
July 12th 2023The FDA has accepted a supplemental biologics license application seeking the approval of zanubrutinib in combination with obinutuzumab in the treatment of adult patients with relapsed/refractory follicular lymphoma who received at least 2 prior lines of therapy.
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LOTIS-9 Trial of Loncastuximab Tesirine/Rituximab in Untreated DLBCL Pauses Enrollment
July 11th 2023ADC Therapeutics has voluntarily paused enrollment to the phase 2 LOTIS-9 trial investigating the combination of loncastuximab tesirine and rituximab for use in unfit or frail patients with previously untreated diffuse large B-cell lymphoma.
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First-line Nivolumab Plus Chemo Provides Survival Benefit in Metastatic Urothelial Carcinoma
July 11th 2023Frontline treatment with the combination of nivolumab and cisplatin-based chemotherapy, followed by nivolumab monotherapy, led to a statistically significant improvement in PFS and OS vs standard cisplatin-based chemotherapy regimens alone in previously untreated, cisplatin-eligible patients with unresectable or metastatic urothelial carcinoma.
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Intensified Frontline ABVD Improves PFS in Advanced Classical Hodgkin Lymphoma
July 10th 2023Dose-dense and dose-intense doxorubicin, bleomycin, vinblastine, dacarbazine, and granulocyte colony–stimulating factor (ABVD) generated an improvement in progression-free survival and other efficacy end points compared with PET-adapted ABVD in previously untreated patients with advanced classical Hodgkin lymphoma.
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Zenocutuzumab Wins FDA Breakthrough Therapy Designation for Advanced NRG1+ NSCLC
July 7th 2023The FDA has granted breakthrough therapy designation to zenocutuzumab for use as a potential therapeutic option in patients with advanced unresectable or metastatic, NRG1 fusion–positive non–small cell lung cancer following progression with prior systemic therapy.
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Paxalisib Plus Radiation Earns FDA Fast Track Status for PI3K+ Solid Tumor Brain Metastases
July 7th 2023The FDA has granted a fast track designation to paxalisib in combination with radiation therapy for the treatment of patients with solid tumor brain metastases harboring PI3K pathway mutations.
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FDA Lifts Partial Clinical Hold on TakeAim Leukemia Trial of Emavusertib in AML/MDS
July 6th 2023The FDA has lifted a partial clinical hold on the phase 1/2 TakeAim Leukemia trial evaluating emavusertib monotherapy and in combination with azacitidine and venetoclax in patients with relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndrome.
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FDA Grants Priority Review to Zolbetuximab for CLDN18.2+ Advanced Gastric/GEJ Adenocarcinoma
July 6th 2023The FDA has granted a priority review to the biologics license application seeking the approval of zolbetuximab for the first-line treatment of patients with unresectable, locally advanced or metastatic, HER2-negative, gastric or gastroesophageal junction adenocarcinoma whose tumors are Claudin18.2 positive.
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FDA Approves Ready-to-Dilute Cyclophosphamide Injection for Various Cancers
July 5th 2023The FDA has approved a new drug application for 200-mg/mL vials of cyclophosphamide injection for use in combination therapy in the treatment of patients with various types of cancers, including malignant lymphoma, multiple myeloma, and various types of leukemia.
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Datopotamab Deruxtecan Significantly Improves PFS in Advanced NSCLC
July 5th 2023Datopotamab deruxtecan provided a statistically significant improvement in progression-free survival compared with standard-of-care docetaxel in patients with locally advanced or metastatic non–small cell lung cancer who received at least 1 prior line of therapy.
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Intra-arterial Gemcitabine Improves OS in Locally Advanced Pancreatic Cancer
June 29th 2023Treatment with intra-arterial gemcitabine led to an improvement in overall survival compared with continued treatment with intravenous gemcitabine plus nab-paclitaxel in patients with locally advanced pancreatic cancer following sequential treatment with IV gemcitabine, nab-paclitaxel, and radiotherapy.
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