Product Approval Summaries

DEVICES FDA has cleared a Bone Index 510(k) for the Bindex point-of-care instrument, which is intended to help in osteoporosis diagnosis. The device measures the cortical bone thickness of the tibia and its algorithm calculates a density index, a parameter which estimates bone mineral density at the hip as measured with dual-energy x-ray absorptiometry, according to the company. It detects osteoporosis with 90% sensitivity and specificity, it says, adding that the clinical validation for Bindex was conducted with over 2,000 patients.FDA has approved a Boston Scientific PMA for its Precision Montage MRI Spinal Cord Stimulator (SCS) System which is intended to help relieve chronic pain while also enabling safe access to full body magnetic resonance imaging in a 1.5 Tesla environment. The device uses the company’s MultiWave technology to deliver multiple waveforms, including burst and higher rates, that helps patients respond to changes in pain over time, according to the company. “In an analysis of registry information from 800 patients, it was determined that 72% used multiple waveforms to customize their therapy and optimize pain relief,” it says. “The new SCS system also expands the suite of Boston Scientific products that leverage the Illumina 3D algorithm, a three-dimensional anatomy-driven computer model designed for simple point-and-click pain targeting to support physicians in treating chronic pain.”Roche received FDA approval of the Ventana PD-L1 (SP142) Assay1 as a complementary diagnostic to provide PD-L1 status on patients who are considering treatment with the Roche immunotherapy Tecentriq (atezolizumab) for metastatic urothelial cancer.
HUMAN DRUGSFDA has approved Bristol-Myers Squibb’s supplemental biologics license application for Opdivo for treating patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation Adcetris (brentuximab vedotin).FDA has approved an Eisai NDA for Lenvima (lenvatinib) capsules for combination use with everolimus for treating advanced renal cell carcinoma following one prior anti-angiogenic therapy. Lenvatinib was first approved in 2015 for treating locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.FDA has granted Genentech accelerated approval for Tecentriq (atezolizumab) for treating people with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months after receiving chemotherapy.Glenmark Pharmaceuticals has received final FDA approval to sell rufinamide tablets 200 mg and 400 mg, a generic version of Eisai Co.’s Banzel, used to treat epilepsy and its symptoms such as seizures.