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FDA Approves Lower Dose of Rivaroxaban for Recurrent VTE The U . S . Food and Drug Administration ( FDA ) approved 10 mg once-daily dosing for rivaroxaban to prevent recurrent venous thromboembolism ( VTE ) after at least six months of initial anticoagulation therapy . Physicians should continue to start patients on rivaroxaban 15 mg twice-daily for the first 21 days after a VTE event , then change the dose to 20 mg once-daily on days 22 through 180 , and then decrease the daily dose to 10 mg at six months .
The decision was based on data from the EINSTEIN CHOICE trial , which found that treatment with rivaroxaban led to a lower risk of recurrent VTE , compared to aspirin , with similar rates of major bleeding . The study evaluated patients with VTE who were already treated with six to 12 months of initial anticoagulation therapy and then received rivaroxaban 10 mg once-daily , rivaroxaban 20 mg oncedaily , or aspirin 100 mg once-daily for as long as 12 months . Patients taking either rivaroxaban dose had significantly fewer recurrent VTE episodes , compared with those taking aspirin : Rivaroxaban 10 mg reduced the risk of recurrent VTE by 74 percent , and rivaroxaban 20 mg reduced it by 66 percent . All three treatment groups had low rates of major bleeding ( 0.4 % with rivaroxaban 10 mg , 0.5 % with rivaroxaban 20 mg , and 0.3 % with aspirin ).
Source : Janssen Pharmaceuticals press release , October 30 , 2017 .
FDA Grants Accelerated Approval to Acalabrutinib for Mantle Cell Lymphoma The FDA granted accelerated approval to the kinase inhibitor acalabrutinib for adults with previously treated mantle cell lymphoma ( MCL ).
The approval was based on findings from the single-arm , phase II ACE-LY-004 study , which included 124 patients with MCL who had received at least one prior treatment ( median = 2 therapies ; range = 1-5 therapies ). Patients received acalabrutinib 100 mg orally twice-daily . After a median follow-up of 15.2 months ( range not provided ), the objective response rate was 81 percent ( 95 % CI 73-87 ), including 40 percent who achieved a complete response ( CR ) and 41 percent who achieved
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a partial response ( PR ). The median time to best response was 1.9 months ( range not provided ), and the median duration of response had not been reached ( 20 + months ).
Adverse events ( AEs ) associated with acalabrutinib include headache , diarrhea , bruising , fatigue , myalgia , anemia , thrombocytopenia , and neutropenia . Serious AEs include hemorrhage , infection , and atrial fibrillation . Second primary malignancies ( SPMs ) were also reported . Dose reductions related to AEs were required in 1.6 percent of patients , and 6.5 percent of patients discontinued treatment because of AEs .
Acalabrutinib previously received priority review , breakthrough-therapy , and orphan-drug designations for this indication .
Source : U . S . Food and Drug Administration news release , October 31 , 2017 .
BCMA Antibody-Drug Conjugate Receives Breakthrough-Therapy Designation for Myeloma The FDA granted breakthrough-therapy designation to the B-cell maturation antigen antibody-drug conjugate GSK2857916 for relapsed / refractory multiple myeloma ( MM ). The drug is indicated for patients for whom at least three prior lines of therapy have failed , including an anti- CD38 antibody , and whose disease is refractory to a proteasome inhibitor and an immunomodulatory agent .
The FDA ’ s decision was based on results from an open-label , dose-escalation and -expansion , phase I study of 24 patients with relapsed / refractory MM who were treated at eight dose levels . GSK2857916 is administered every three weeks with no mandatory prophylaxis for infusion-related reactions ( IRRs ).
Treatment responses included one minimal response ( MR ) at the 0.24 mg / kg dose and one very good PR , three PRs , and one MR at doses ≥0.96 mg / kg . The clinical benefit rate ( including unconfirmed responses ) was 25 percent .
Seven patients ( 29 %) had adverse cytogenetics , including del17p13 or t ( 4 ; 14 ). Twenty-three patients ( 96 %) experienced AEs , the most common of which were nausea ( 42 %), fatigue ( 38 %), anemia ( 29 %), chills ( 29 %), pyrexia ( 29 %), thrombocytopenia ( 29 %), dry eye ( 21 %), and hypercalcemia ( 21 %). Eight serious AEs were reported among six patients , including one
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incidence of unresolved limbal stem cell dysfunction that was deemed treatment related . No AEs led to treatment discontinuation , but four patients required dose reductions because of ocular toxicity , corneal disorder / ocular toxicity , dry eye , and keratitis . Seven patients ( 29 %) experienced IRRs , all of which were grade 1 or 2 and occurred during the first treatment dose .
Fourteen patients discontinued treatment because of disease progression . One patient completed all 16 scheduled cycles , and eight patients were still undergoing treatment at the time of analysis
GSK2857916 previously received orphan-drug designation for relapsed / refractory MM .
Source : GlaxoSmithKline press release , November 2 , 2017 .
FDA Okays Complete Blood Cell Count Test The FDA cleared the XW-100 Automated Hematology Analyzer , a complete blood cell count ( CBC ) test that can be used in more health-care settings – including physicians ’ offices and clinics – and by a wider range of support staff than available testing methods . The test also delivers faster results .
“ A CBC is one of the most common physician-ordered tests . … However , in the current health-care setting , nonhospitalized patients who require a CBC can experience at least a 24-hour wait for test results , if not longer , when the test is performed by an off-site laboratory ,” said Donald St . Pierre , acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA ’ s Center for Devices and Radiological Health . “ This waiting period may be detrimental to the health of patients whose care depends on quick results to rule out conditions that may require immediate medical intervention .”
The FDA ’ s decision was based on data from a study conducted on 582 blood samples ( from patients 2-92 years of age ) that compared results collected from the XW-100 Automated Hematology Analyzer by non-medical personnel in CLIA-waived settings and those collected from a hematology analyzer in an accredited clinical laboratory . The study found that accurate testing can be effectively conducted by untrained personnel .
The device works by using a blood sample to classify and quantify 12 hematology parameters , and the test is intended for patients two years or older who require a whole blood cell count and white blood cell differential . The test can be used with
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The new complete blood cell count test shortens the waiting period for test results , potentially improving the health of patients whose care depends on quick results . other clinical and laboratory findings to provide information on conditions such as severe anemia and agranulocytosis ; however , it is not intended to diagnose or monitor patients with primary and / or secondary hematologic diseases .
The device received premarket clearance and a CLIA waiver .
Source : U . S . Food and Drug Administration news release , November 6 , 2017 .
Vemurafenib Receives FDA Approval for Treatment of Rare Erdheim-Chester Disease The FDA expanded the approval of the kinase inhibitor vemurafenib to include adults with Erdheim-Chester disease ( ECD ) and the BRAF V600 mutation , making this the first FDA-approved treatment for ECD – a rare , serious blood disease characterized by the abnormal multiplication of certain white blood cells called histiocytes .
The indication was based on results from the open-label , multicenter , singlearm , multicohort , phase II VE-BASKET study , which enrolled 22 patients with BRAF V600 – positive ECD to receive vemurafenib . After a median follow-up
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