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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Talquetamab Wins Approval in Europe for Relapsed/Refractory Myeloma
August 22nd 2023The European Commission has granted conditional marketing authorization to talquetamab-tgvs monotherapy for the treatment of patients with relapsed/refractory multiple myeloma who have received at least 3 prior therapies and have demonstrated disease progression on the last therapy.
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Second-Line Axi-Cel Elicits Complete Metabolic Responses in Transplant-Ineligible LBCL
August 18th 2023Second-line treatment with axicabtagene ciloleucel led to an investigator-assessed, 3-month complete metabolic response rate of 71.0% in patients with large B-cell lymphoma who were ineligible for autologous stem cell transplant.
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European Commission Approves Reduced Dosing of Teclistamab in Relapsed/Refractory Myeloma
August 18th 2023The European Commission has approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5 mg/kg every 2 weeks in patients with relapsed/refractory multiple myeloma who have achieved a complete response or better for a minimum of 6 months.
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EMA Accepts Marketing Application for Odronextamab in R/R DLBCL or Follicular Lymphoma
August 17th 2023The European Medicines Agency has accepted a marketing authorization application seeking the approval of odronextamab for the treatment of adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma who have progressed after at least 2 prior systemic therapies.
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Repotrectinib Sustains ORR, Safety in Locally Advanced or Metastatic ROS1+ NSCLC
August 16th 2023Treatment with repotrectinib continued to produce high and durable responses with a manageable safety profile in patients with ROS1-positive locally advanced or metastatic non–small cell lung cancer who were naïve to a TKI or previously treated with 1 TKI and no chemotherapy.
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Tucatinib Plus T-DM1 Improves PFS in Previously Treated HER2+ Metastatic Breast Cancer
August 16th 2023The combination of tucatinib and ado-trastuzumab emtansine elicited an improvement in progression-free survival compared with placebo plus T-DM1 in patients with HER2-positive metastatic breast cancer who received previous treatment with a taxane and trastuzumab in any setting.
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FDA Grants Priority Review to Ivosidenib for IDH1+ Relapsed/Refractory MDS
August 15th 2023The FDA has granted priority review to the supplemental new drug application seeking the approval of ivosidenib for the treatment of patients with IDH1-mutated, relapsed/refractory myelodysplastic syndrome.
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FDA Lifts Clinical Hold on BCMA-Directed Modified CAR T-Cell Therapy in Multiple Myeloma
August 15th 2023The FDA has lifted the partial clinical hold placed on the clinical program evaluating the investigational new drug, CART-ddBCMA, in the treatment of patients with relapsed/refractory multiple myeloma.
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BAT8006 Elicits Disease Control, Safety in Advanced Ovarian Cancer and Other Solid Tumors
August 14th 2023Treatment with the folate receptor–α antibody-drug conjugate BAT8006 led to responses with a manageable safety profile in patients with advanced solid tumors, including ovarian cancer, breast cancer, and cervical cancer.
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BDC-1001 Monotherapy Under Further Evaluation in Phase 2 Trial in HER2+ Cancers
August 11th 2023The first patients have been dosed in the phase 2 portion of a phase 1/2 trial evaluating BDC-1001 monotherapy in patients with HER2-positive colorectal cancer, endometrial cancer, and gastroesophageal cancer.
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