FDA Places Clinical Hold on Phase 1 Trial of XMT-2056 in HER2-expressing Solid Tumors
March 13th 2023The FDA has placed a clinical hold on a phase 1 trial investigating the antibody-drug conjugate XMT-2056 for the treatment of patients with advanced/recurrent solid tumors that express HER2.
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FDA Receives Type A Meeting Request for Synthetic Hypericin in Early-stage Cutaneous T-cell Lymphoma
March 13th 2023Soligenix has submitted a Type A meeting request to the FDA to discuss the contents of a refusal to file letter from the regulatory agency regarding the new drug application for synthetic hypericin for the treatment of early-stage cutaneous T-cell lymphoma.
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Pembrolizumab Plus Chemotherapy Meets OS End Point in Advanced Malignant Pleural Mesothelioma
March 10th 2023First-line treatment with the combination of pembrolizumab and chemotherapy generated a statistically significant and clinically meaningful improvement in overall survival compared with chemotherapy alone in patients with unresectable advanced or metastatic malignant pleural mesothelioma.
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Adjuvant Osimertinib Elicits OS Improvement in Early-Stage EGFR-Mutated NSCLC
March 9th 2023Osimertinib produced a statistically significant and clinically meaningful improvement in overall survival compared with placebo as adjuvant treatment for patients with stage IB, II, or IIIA, EGFR-mutated non–small cell lung cancer after complete tumor resection with curative intent.
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FDA Grants Fast Track Designation to IK-175 in Combination With Nivolumab in Urothelial Carcinoma
March 8th 2023The FDA has granted a fast track designation to the novel aryl hydrocarbon receptor antagonist IK-175 in combination with nivolumab for the treatment of patients with advanced urothelial carcinoma who have progressed on or within 3 months of receiving the last dose of checkpoint inhibitors.
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FDA Accepts BLA Resubmission for Remestemcel-L in Pediatric Steroid-Refractory aGVHD
March 8th 2023The FDA’s Office of Therapeutic Products has accepted a resubmission of the biologics license application (BLA) for remestemcel-L for the treatment of pediatric patients with steroid-refractory, acute graft-vs-host-disease.
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EU Approves Luspatercept for Anemia in Patients with Non–Transfusion-Dependent Beta Thalassemia
March 7th 2023The European Commission has granted a full marketing authorization to luspatercept-aamt for use in adult patients with anemia associated with non–transfusion-dependent β-thalassemia.
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Incyte to Discontinue Phase 3 LIMBER-304 Trial of Parsaclisib Plus Ruxolitinib in Myelofibrosis
March 6th 2023The phase 3 LIMBER-304 trial evaluating parsaclisib plus ruxolitinib in patients with myelofibrosis will be discontinued after results of a preplanned interim analysis indicated that the study is unlikely to meet its primary end point of targeted reduction in spleen volume in the intent-to-treat population.
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Trastuzumab Deruxtecan Meets ORR End Point in HER2-expressing Advanced Solid Tumors
March 6th 2023The antibody-drug conjugate trastuzumab deruxtecan met the prespecified target for objective response rate and demonstrated durable responses in heavily pretreated patients with HER2-expressing advanced solid tumors in the phase 2 DESTINY-PanTumor02 trial.
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Progress in Treating Brain Metastases in Breast Cancer Puts Multidisciplinary Approaches Into Focus
March 4th 2023Brain metastases are a common complication in patients with breast cancer, and although systemic therapies for patients with HER2-positive disease have displayed promise in penetration of the blood-brain barrier, work remains for subsets of patients with central nervous system metastases.
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ADC Developments in HER2– Breast Cancer Treatment Shake Up Paradigm
March 3rd 2023As additional antibody-drug conjugates continue to emerge for the treatment of patients with HER2-negative breast cancer, identifying optimal sequencing strategies and managing toxicities associated with these agents remain top priorities for their use, according to Hope S. Rugo, MD.
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A new drug application has been submitted to the FDA seeking the approval of niraparib in combination with abiraterone acetate, in the form of a dual-action tablet, and prednisone, for the first-line treatment of patients with metastatic castration-resistant prostate cancer harboring BRCA mutations.
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The FDA has accepted a supplemental biologics license application for neoadjuvant pembrolizumab in combination with platinum-containing chemotherapy, followed by adjuvant pembrolizumab monotherapy, for the treatment of patients with resectable stage II, IIIA, or IIIB (T3-4N2) non–small cell lung cancer.
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Enrollment Begins for Phase 2 Trial of IMNN-001 Plus Bevacizumab/Chemo in Advanced Ovarian Cancer
February 28th 2023Enrollment has commenced for a phase 2 trial investigating the DNA-based interleukin-12 immunotherapy IMNN-001 in combination with bevacizumab and chemotherapy in patients with advanced ovarian cancer.
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MHRA Approves Selinexor Plus Bortezomib/Dexamethasone for Multiple Myeloma Following 1 Prior Therapy
February 21st 2023The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has granted full marketing authorization for selinexor in combination with bortezomib and low-dose dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 prior therapy.
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Talazoparib Plus Enzalutamide Improves rPFS in First-line mCRPC
February 16th 2023Talazoparib plus enzalutamide generated a statistically significant and clinically meaningful improvement in radiographic progression-free survival vs placebo plus enzalutamide as first-line treatment for patients with metastatic castration-resistant prostate cancer, irrespective of homologous recombination repair status.
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ADI-001 Produces Responses, Favorable Safety in Relapsed/Refractory B-Cell NHL
February 16th 2023ADI-001, a first-in-class, allogeneic gamma delta1 CAR T-cell therapy, elicited responses and demonstrated a favorable safety profile in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.
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FDA Grants Priority Review to Avasopasem for Radiotherapy-Induced Severe Oral Mucositis
February 15th 2023The FDA has granted priority review to the new drug application for avasopasem manganese as a treatment for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment.
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Trilaciclib Plus Bevacizumab/FOLFOXIRI Reduces Severe Neutropenia, Fails to Improve Efficacy in mCRC
February 13th 2023Adding trilaciclib to FOLFOXIRI and bevacizumab led to statistically significant reductions in instances of severe neutropenia during induction and duration of severe neutropenia in cycles 1 to 4. However, the combination failed to improve antitumor activity vs placebo plus FOLFOXIRI/bevacizumab in patients with metastatic colorectal cancer.
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Ide-cel Improves PFS vs SOC in Relapsed/Refractory Multiple Myeloma
February 10th 2023Idecabtagene vicleucel improved progression-free survival compared with standard combination regimens in patients with relapsed/refractory multiple myeloma after 2 to 4 prior lines of therapy and who were refractory to their last regimen, according to results from the phase 3 KarMMa-3 trial.
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Development of Seribantumab for NRG1+ Advanced Solid Tumors Put On Hold
February 9th 2023Elevation Oncology is pausing development of the human anti–HER3 IgG2 monoclonal antibody seribantumab, along with the phase 2 CRESTONE trial investigating the agent, in patients with advanced solid tumors harboring NRG1 fusions.
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