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FDA Approves Burosumab for Treatment of Tumor-Induced Osteomalacia
June 23rd 2020"As the first FDA-approved therapy to treat this debilitating disease, today’s action is an important step in finding treatment options for patients living with tumor-induced osteomalacia whose tumor cannot be found or removed."
Preclinical Models Show Benefit for Novel BTK Inhibitor in MCL, NHL
June 23rd 2020"When compared to ibrutinib, TG-1701 used at high doses retained notable antitumor activity in MCL cells with BTK C481S mutation, while it did not show superior activity than the first-in-class BTK [inhibitor] in in vitro and in vivo models of ibrutinib-resistant MCL with constitutive activation of the non-canonical NF-KB pathway.”
sNDA Seeks Expanded Approval of Ibrutinib in Waldenström's Macroglobulinemia
June 23rd 2020"The iNNOVATE study continues to deliver strong clinical evidence supporting the long-term use of ibrutinib plus rituximab across first and second lines of therapy for patients with Waldenström's macroglobulinemia."
Researcher Evaluates Next Steps for Incorporating CAR T-Cell Therapy into Solid Tumor Space
June 23rd 2020In an interview with Targeted Oncology, Prasad S. Adusumilli, MD, FACS, discussed how CAR T-cell therapy could play a role in the treatment of solid tumors. He highlighted the current research and next steps planned to move this cellular therapy into the solid tumor treatment landscape.
Selinexor Introduces a New Mechanism of Action to Treat Relapsed or Refractory DLBCL
June 22nd 2020In an interview with Targeted Oncology, Michael Schuster, MD, discussed the findings in the phase 2 SADAL study and the importance of the FDA approval of selinexor for the treatment of relapsed/refractory diffuse large B-cell lymphoma.
FDA’s ODAC to Review Belantamab Mafodotin BLA for R/R Multiple Myeloma
June 22nd 2020The FDA has announced plans to convene a meeting of the Oncologic Drugs Advisory Committee to review the Biologic License Application for belantamab mafodotin as treated of patients with relapsed or refractory multiple myeloma.
FDA Approves Selinexor for R/R Diffuse Large B-Cell Lymphoma
June 22nd 2020Selinexor is now the only single-agent, oral therapy approved for the treatment of patients with R/R DLBCL, and the only nuclear export inhibitor approved by the FDA for use in 2 hematologic malignancies, multiple myeloma and DLBCL.
iNEST/Atezolizumab Combo Induces Neoantigen-Specific T-Cell Responses in Advanced Solid Tumors
June 22nd 2020“RO7198457 in combination with atezolizumab induced immune responses in the majority of patients, including preliminary data demonstrating the detection of neoantigen-specific T-cell responses within the tumor."
Disparities Seen in Hematologic Cancer Incidence and Survival for Hispanic Patients in Texas
June 22nd 2020“[This] report on the diagnosis of blood cancers in the US/Mexico border inure the different frequency of leukemia subtypes and their outcomes, highlighting important health disparities due to different access to diagnosis and care due to a series of factors."
RAS/MAPK Pathway Mutations Show Association With Adverse Survival Outcomes in Myelofibrosis
June 19th 2020“RASMT associated with adverse phenotypic features were concluded to be an independent predictor of inferior overall survival and were associated with a higher cumulative incidence of leukemic transformation."
Encouraging Larotrectinib Data Underscores Importance of Genetic Testing in Metastatic Solid Tumors
June 18th 2020In an interview with Targeted Oncology, Marcia Brose, MD, PhD, discussed the importance of conducting genetic testing on all patients with metastatic solid tumors following the exciting data on larotrectinib.
Fruquitinib Receives FDA Fast Track Designation for Metastatic Colorectal Cancer
June 18th 2020Fruquitinib was granted Fast Track Designation for the treatment of patients with metastatic colorectal cancer who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and anti-VEGF therapy, as well as anti-EGFR therapy for RAS wild-type tumors
AON Announces Forthcoming Collaboration with Sarah Cannon to Expand Cancer Research
June 17th 2020“Community-based clinical trials come with many benefits. They enable patients to be matched with potentially life-saving research while staying within the comfort and familiarity of their local oncologist’s office.”
Preventative Measures and Cancer Screening Recommendations Aid Male Population
June 17th 2020"Cancer is now the number 1 cause of death in many parts of the United States and overall, men are at a 50% likelihood of having some sort of cancer diagnosed in their lifetime, where it is slightly lower in women at about a third."
Rolling NDA Submitted to FDA for Umbralisib as Treatment of Marginal Zone, Follicular Lymphomas
June 17th 2020“The completion of this New Drug Application submission marks an important milestone in bringing us 1 step closer to providing umbralisib as a potential treatment option for patients with relapsed/refractory marginal zone lymphoma and follicular lymphoma."
Immunotherapy Combinations Provide Long-Term Benefit in Stage IV NSCLC
June 17th 2020In an interview with Targeted Oncology, Suresh Ramalingam, MD, FASCO, discussed the findings from the CheckMate 227 study that support the FDA’s approval of the combination of nivolumab and ipilimumab in patients with advanced NSCLC.
FDA Approves Pembrolizumab for TMB-High Solid Tumors
June 16th 2020"KEYNOTE-158 has confirmed clinical activity of pembrolizumab in tumors harboring a TMB ≥10 across a variety of solid tumors including anal, biliary, cervical, endometrial, mesothelioma, neuroendocrine, salivary, small cell lung, thyroid, and vulvar cancers."
Mirvetuximab Plus Bevacizumab Combo Appears Durable in Platinum-Agnostic Ovarian Cancer
June 16th 2020In an interview with Targeted Oncology, Lucy Gilbert, MD, MSc, discussed the interim findings for mirvetuximab in combination with bevacizumab as treatment of patients with platinum-agnostic ovarian cancer.
CD40 Agonist Plus Chemotherapy Hypothesized to Improve Outcomes in Metastatic PDAC
June 16th 2020In an interview with Targeted Oncology, Andrew L. Coveler, MD, discussed the phase 1 trial study of SEA-CD40 combined with a chemotherapy regimen, which he recently presented during the ASCO Virtual Scientific Program.
Gemtuzumab Ozogamicin FDA Approval Extended to Pediatric CD33-Positive Acute Myeloid Leukemia
June 16th 2020The FDA expanded the approval of gemtuzumab ozogamicin to include an indication for the treatment of newly diagnosed pediatric patients with CD33-positive acute myeloid leukemia, which includes patients as young as 1 month old.