FDA Grants Fast Track Designation to IDE161 for BRCA+, Platinum-Resistant Advanced Ovarian Cancer
September 26th 2023The FDA has granted fast track designation to IDE161 for the treatment of adult patients with advanced or metastatic ovarian cancer harboring germline or somatic BRCA1/2 mutations who are platinum resistant and have received prior treatment with antiangiogenic and PARP inhibitor therapies.
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First-line treatment with lutetium Lu 177 dotatate plus long-acting octreotide led to a statistically significant and clinically meaningful improvement in progression-free survival compared with high-dose long-acting octreotide alone in newly diagnosed patients with somatostatin receptor–positive, grade 2 and 3, advanced gastroenteropancreatic neuroendocrine tumors.
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Pembrolizumab/Lenvatinib Regimens Miss Survival End Points in Metastatic NSCLC
September 22nd 2023The first-line combination of pembrolizumab, lenvatinib, pemetrexed, and platinum-containing chemotherapy did not meet the dual primary end points of overall survival and progression-free survival compared with pembrolizumab plus pemetrexed and platinum-containing chemotherapy in patients with metastatic, nonsquamous non–small cell lung cancer in whom EGFR-, ALK- or ROS1-directed therapies were not indicated.
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Treatment with the combination of enfortumab Vedotin and pembrolizumab led to an improvement in overall survival and progression-free survival compared with chemotherapy in previously untreated patients with locally advanced or metastatic urothelial cancer who were eligible for cisplatin- or carboplatin-containing chemotherapy.
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Perioperative Nivolumab Plus Chemotherapy Improves EFS in Resectable NSCLC
September 22nd 2023Neoadjuvant treatment with nivolumab plus platinum-based chemotherapy, followed by surgery and adjuvant nivolumab monotherapy, generated a statistically significant and clinically meaningful improvement in event-free survival vs neoadjuvant chemotherapy plus placebo, followed by surgery and adjuvant placebo, in patients with resectable stage IIA to IIIB non–small cell lung cancer.
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The FDA has granted priority review to a supplemental biologics license application seeking the approval of pembrolizumab in combination with external beam radiotherapy plus concurrent chemotherapy, followed by brachytherapy, for the treatment of newly diagnosed patients with high-risk, locally advanced cervical cancer.
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Tislelizumab Approved in Europe for Advanced ESCC After Platinum-Based Chemotherapy
September 19th 2023The European Commission has approved tislelizumab monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy.
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Oral Decitabine and Cedazuridine Wins EU Approval for Newly Diagnosed AML
September 19th 2023The European Commission has approved oral decitabine and cedazuridine for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are ineligible for standard induction chemotherapy.
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FDA Grants Priority Review to Belzutifan in Previously Treated Advanced RCC
September 19th 2023The FDA has granted priority review to the supplemental new drug application seeking the approval of belzutifan for the treatment of previously treated patients with advanced renal cell carcinoma following immune checkpoint and anti-angiogenic therapies.
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CHMP Recommends Against Renewal of Marketing Authorization for Belantamab Mafodotin in R/R Myeloma
September 18th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended against renewal of the conditional marketing authorization for belantamab mafodotin-blmf for the treatment of patients with relapsed/refractory multiple myeloma who have received at least 4 prior treatments.
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Trastuzumab Biosimilar Receives CHMP Recommendation for HER2+ Breast and Gastric Cancer
September 18th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorization of EirGenix’s biosimilar for trastuzumab for the treatment of patients with HER2-positive breast and metastatic gastric cancers.
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Adjuvant Pembrolizumab Receives Positive CHMP Opinion for High-Risk NSCLC After Resection and Chemo
September 15th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab as adjuvant treatment for adult patients with non–small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
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FDA Extends Priority Review of BLA for Lifileucel in Advanced Melanoma
September 15th 2023The FDA has extended the priority review period for the biologics license application seeking the approval of the tumor infiltrating lymphocyte therapy lifileucel for the treatment of patients with advanced melanoma who progressed on or after anti–PD-1/PD-L1 therapy and targeted therapy.
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FDA Approves New and Updated Indications for Temozolomide in Anaplastic Astrocytoma
September 14th 2023The FDA has approved temozolomide (Temodar) for the adjuvant treatment of adult patients with newly diagnosed anaplastic astrocytoma. Under Project Renewal, the regulatory agency has also revised indications for the treatment of patients with refractory anaplastic astrocytoma.
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Golidocitinib NDA Under NMPA Review for Relapsed/Refractory PTCL
September 14th 2023The Center for Drug Evaluation of China’s National Medical Products Administration has accepted the new drug application seeking the approval of golidocitinib for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma.
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A marketing authorization application has been submitted to the European Medicines Agency seeking the approval of erdafitinib for the treatment of adult patients with locally advanced, unresectable or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations who experienced disease progression during or following at least 1 line of therapy containing a PD-1/PD-L1 inhibitor.
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FDA Approval Sought for Tovorafenib in Relapsed or Progressive Pediatric Low-Grade Glioma
September 11th 2023A rolling new drug application seeking the approval of tovorafenib monotherapy for the treatment of patients with relapsed or progressive pediatric low-grade glioma has been submitted to the FDA.
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FDA Approves Motixafortide Plus Filgrastim for ASCT in Multiple Myeloma
September 11th 2023The FDA has approved motixafortide (Aphexda) in combination with filgrastim (Neupogen) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous stem cell transplant in patients with multiple myeloma.
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Tisotumab Vedotin Improves OS in Recurrent/Metastatic Cervical Cancer
September 5th 2023Treatment with tisotumab vedotin-tftv monotherapy led to an improvement in overall survival compared with chemotherapy alone in patients with recurrent or metastatic cervical cancer that progressed on or after frontline therapy.
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Alectinib Meets DFS End Point in ALK+ Early-Stage NSCLC
September 1st 2023Adjuvant treatment with alectinib generated a statistically significant and clinically meaningful improvement in disease-free survival compared with platinum-based chemotherapy in patients with completely resected stage IB to IIIA, ALK-positive non–small cell lung cancer.
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Mezigdomide Plus Dexamethasone Elicits Responses With Acceptable Safety in R/R Myeloma
August 30th 2023Treatment with combination of mezigdomide and dexamethasone produced responses with a safety profile that consisted primarily of myelotoxic adverse effects in heavily pretreated patients with relapsed/refractory multiple myeloma.
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FDA Approval Sought for Erdafitinib in Locally Advanced or Metastatic FGFR3+ Urothelial Carcinoma
August 29th 2023A supplemental new drug application seeking the full approval of erdafitinib for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations who progressed during or following at least 1 line of a PD-1/PD-L1 inhibitor in the locally advanced or metastatic setting or within 12 months of neoadjuvant or adjuvant therapy, has been submitted to the FDA.
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