Today’s Daily Dose brings you news about encouraging preliminary data of Immune Design’s phase II trial of CMB305 in soft tissue sarcoma; Novartis scripting history – with the FDA approval of its CAR-T therapy; FDA approval of Medicines Co.’s VABOMERE and Teva’s AUSTEDO; disappointing results from Otonomy’s phase III clinical trial of OTIVIDEX; the seventh FDA approval Roche’s Actemra and Vivus resolving the pending lawsuit related to its weight-loss drug.
Amgen Inc.’s (AMGN) supplemental New Drug Application to add overall survival results to KYPROLIS’ label has been accepted for review by the FDA – with a decision date set for April 30, 2018.
In a phase III head-to-head trial, dubbed ENDEAVOR, KYPROLIS and dexamethasone reduced the risk of death by 21 percent and increased overall survival by 7.6 months compared to Velcade and dexamethasone in patients with relapsed or refractory multiple myeloma.
KYPROLIS was approved in the U.S. in 2012 and in Europe in 2015. The drug netted total sales of $692 million in 2016, up 35% over the prior year.
AMGN closed Wednesday’s trading at $173.65, up 0.82%.
An interim analysis of Immune Design Corp’s (IMDZ) phase II trial evaluating CMB305 in combination with Roche’s Tecentriq in soft tissue sarcoma patients has shown that there is a greater clinical benefit and immune response with CMB305 plus Tecentriq than with Tecentriq alone.
The trial, which is fully enrolled is comparing the safety, immunogenicity and efficacy of CMB305 in combination with Tecentriq against Tecentriq alone, in a total of 88 patients with locally advanced, relapsed, or metastatic NY-ESO-1+ synovial sarcoma or myxoid/round-cell liposarcoma.
Immune Design intends to present survival data from the trial in 2018 once all patients have at least one year of follow up.
IMDZ closed Wednesday’s trading at $10.10, up 2.02%.
The Medicines Co.’s (MDCO) VABOMERE has been granted accelerated approval by the FDA for the treatment of adult patients with complicated urinary tract infections, including pyelonephritis.
VABOMERE addresses gram-negative bacteria that produce beta-lactamase enzymes that have spread in the United States and Europe, particularly the Klebsiella pneumoniae carbapenemase (KPC) enzyme, the Company noted.
The drug is expected to be available in the fourth quarter of 2017. The FDA approval of VABOMERE triggered a $40 million milestone payment obligation to the former security holders of Rempex Pharmaceuticals Inc., which the Medicines Co….