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Split-Dosing of Daratumumab Approved by FDA for Multiple Myeloma
February 13th 2019Based on findings from the phase Ib EQUULEUS (MMY1001) trial, a split-dosing regimen of daratumumab has been approved by the FDA for patients with multiple myeloma, providing physicians the option to split the first infusion of the CD38-directed monoclonal antibody over 2 consecutive days or complete in a single session.
Pembrolizumab Receives Priority Review Designation from FDA for Frontline HNSCC
February 12th 2019Based on data from the phase III KEYNOTE-048 trial, pembrolizumab has received a priority review designation from the FDA alone or in combination with platinum and 5-fluorouracil chemotherapy as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma.
Phase III Isatuximab Trial Meets Primary Endpoint of Improving PFS in Relapsed/Refractory Myeloma
February 11th 2019The phase III ICARIA-MM trial has met its primary endpoint of improving progression-free survival with the combination of pomalidomide and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma compared with pomalidomide and dexamethasone alone.
Expert Underscores Importance of Gaining Better Understanding of Mutations in Myelofibrosis
February 8th 2019Angela G. Fleischman, MD, PhD, discusses a clinical trial at her institution investigating the JAK1 inhibitor itacitinib in patients with MF. She also highlights other recent advancements for patients with MF, as well as advancements in other MPNs such as ET and PV.
Review Period for Ruxolitinib in GVHD Extended by FDA
February 8th 2019The review period for a supplemental new drug application for ruxolitinib has been extended by the FDA by 3 months, making the new action date May 24, 2019. The application is seeking the approval of the JAK1/JAK2 inhibitor as a treatment for patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids.<br />
FDA's ODAC Set to Review Selinexor Application in Penta-Refractory Myeloma
February 8th 2019The FDA's Oncologic Drugs Advisory Committee will hold a hearing on February 26, 2019, to discuss a new drug application for selinexor in combination with dexamethasone for the treatment of patients with penta-refractory multiple myeloma.
Targeted Therapy Pioneers Slamon and Druker Awarded Sjoberg Prize
February 8th 2019Clinical researchers Dennis Slamon, MD, PhD, and Brian Druker, MD, were recently honored with the 2019 Sjöberg Prize for their ground-breaking contributions toward targeted therapy for patients with breast cancer and chronic myeloid leukemia, respectively.
Margetuximab Demonstrates Positive PFS Findings in Metastatic HER2+ Breast Cancer
February 7th 2019Patients with heavily pretreated metastatic HER2-positive breast cancer saw an improvement in progression-free survival with margetuximab combined with chemotherapy compared with trastuzumab and chemotherapy, according to findings from the phase III SOPHIA trial.
Caplacizumab-yhdp Approved by FDA For Acquired Thrombotic Thrombocytopenic Purpura
February 7th 2019The first treatment regimen has been approved by the FDA to treat adult patients with acquired thrombocytic thrombocytopenic purpura: the nanobody caplacizumab-yhdp when given in combination with plasma exchange and immunosuppression.
CMS Overlooks Early-Staged Cancer in National Coverage Determination for NGS-Based Testing
February 6th 2019Over 60 healthcare organizations are pressing the Center for Medicare and Medicaid Services to revise its current interpretation of the National Coverage Determination, which they say wrongly excludes germline next-generation sequencing-based testing from Medicare coverage for patients with early-stage cancers.<br />
Pexidartinib Granted Priority Review by FDA for Treatment of Tenosynovial Giant Cell Tumor
February 6th 2019Based on findings from the phase III ENLIVEN study, a new drug application for the investigational, small molecule, CSF1R receptor inhibitor pexidartinib has been granted a priority review by the FDA for the treatment of adult patients with symptomatic tenosynovial giant cell tumor.
Adjuvant T-DM1 Submitted for FDA Approval in High-Risk HER2+ Breast Cancer
February 5th 2019A supplemental Biologics License Application for ado-trastuzumab emtansine (T-DM1; Kadcyla) has been submitted to the FDA seeking approval for the agent as an adjuvant treatment for patients with HER2-positive early breast cancer who had residual disease following neoadjuvant therapy.
Survival Benefit With GI-Based Adjuvant Chemotherapy Regimen in Mucinous Ovarian Cancer
February 5th 2019Data from a retrospective study suggests an adjuvant gastrointestinal-based chemotherapy regimen is more beneficial than one that is gynecologic-based in patients with mucinous ovarian cancer, said Katherine C. Kurnit, MD.
Progress in Treating Rare Cancers Named ASCO's Advance of the Year
February 4th 2019In recognition of the many advancements that have been made in the past year toward developing new therapies for patients with difficult-to-treat, rare cancers, ASCO has chosen progress in treating rare cancers as its Advance of the Year.
Expert Discusses Recent Advances With PARP Inhibitors in Ovarian Cancer
February 4th 2019In an interview with <em>Targeted Oncology</em> during the 2019 SGO Annual Winter Meeting, Shannon Westin, MD, discussed the advances seen with PARP inhibitors in ovarian cancer, novel investigational agents, and the importance of molecular testing.
On Recommendation From FDA, No NDA to be Filed for Tivozanib in RCC
February 1st 2019Based on a recommendation from the FDA, Aveo Oncology has decided not to submit a new drug application for tivozanib. The FDA has advised it was not satisfied with the preliminary overall survival data from the phase III TIVO-3 trial of patients with highly refractory, advanced or metastatic renal cell carcinoma.
Questions Remain for Targeted Therapy Beyond PARP Inhibition in Ovarian Cancer
February 1st 2019Targeted therapy has effectively been established as an option for patients with ovarian cancers. However, beyond PARP inhibition in the <em>BRCA</em>-mutated or homologous recombination deficient population, questions remain about how to best treat these patients, Ramez N. Eskander, MD, said at the 2019 SGO Annual Winter Meeting.
