Miscellaneous Hematological Agents
The risk for herpes zoster (zoster) is elevated during the two years preceding diagnosis and during treatment of hematological cancer.
From May 1 2018 to July 31 2018, 5 cases of death associated with DS in patients taking Idhifa have been reported; in 2 of these cases, DS was listed as the only cause of death.
Xospata was evaluated in the Phase 3 open-label, multicenter, randomized ADMIRAL trial (N=138) which included patients with relapsed or refractory AML with a FLT3 ITD, D835, or I836 mutation.
The FDA approval was supported by clinical data describing structural and functional characterization, preclinical data, human pharmacokinetic data, clinical immunogenicity data, and other data which showed no clinically meaningful differences between Truxima and Rituxan.
The approval was based on data from a randomized, double-blind, double-dummy, actively controlled trial (ECHELON-2) involving 452 patients with certain PTCLs.
More than 4300 blood drives are needed to help stop the shortage from continuing throughout the winter, so the Red Cross is asking organizations to host blood drives in December, January, and February. I
In high-risk patients with mild hypertriglyceridemia, omega-3 fatty acids improved triglyceride levels and reduced major adverse cardiovascular events, according to a new meta-analysis.
The sNDA included data from the REACH1 study (N=71) which evaluated ruxolitinib in combination with corticosteroids in patients with steroid-refractory acute GVHD.
After high flow nasal cannula oxygen therapy, 15% of patients had to be intubated and mechanically ventilated, but the majority stepped down to regular oxygen therapy.
The approval was based on data from the Phase 3 NEURO-TTR study (N=173) which randomized patients with polyneuropathy caused by hATTR amyloidosis to Tegsedi or placebo.
During one month at a single medical center in Illinois in 2018, 34 cases of synthetic cannabinoid associated coagulopathy were identified.
The approval was based on data from the Phase 3 A.R.R.O.W. trial, which demonstrated that Kyprolis 70mg/m2 once-weekly plus dexamethasone achieved superior progression-free survival (PFS) compared with Kyprolis 27mg/m2 twice-weekly with dexamethasone (median PFS: 11.2 months vs 7.6 months; hazard ratio [HR] 0.69; 95% CI, 0.54-0.88; one-sided P=.0014).
Researchers applied machine learning to agnostically search for varicose vein risk factors in a cohort of 493,519 individuals in the UK Biobank.
The approval of Lumoxiti was based on data from a Phase 3 single-arm, open-label trial conducted in patients with histologically confirmed HCL or HCL variant with a need for therapy based on presence of cytopenias or splenomegaly and who had received prior treatment with at least 2 systemic therapies, including a purine nucleoside analog (N=80).
MRD-negativity is defined as <1 CLL cell per 10,000 lymphocytes detected in the blood or bone marrow using sensitive analytical models.
This expanded approval was based on results from the iNNOVATE study, a double-blind, placebo-controlled trial evaluating Imbruvica in combination with rituximab vs placebo + rituximab in 150 patients with either relapsed/refractory disease or previously untreated Waldenström's macroglobulinemia.
CX-01 is designed to block the activity of chemokines that support the resistance of blood cancers to treatment and that contribute to the delay of bone marrow recovery after chemotherapy.
"As more neonate and infant vital sign monitors emerge in this largely unregulated market, physicians and parents should exercise caution incorporating data from these monitors into medical decisions."
This first-in-class drug was previously granted Orphan Drug designation for the treatment of pancreatic cancer, acute myeloid leukemia, Burkitt lymphoma, and myelodysplastic syndromes.
The Company announced results from a Phase 2 trial involving 45 patients with BPDCN earlier this year.
The designation was based on results from the Phase 3 QuANTUM-R trial, which included 367 participants who were randomized to receive quizartinib or salvage chemotherapy (SC).
SRF231 is a fully human monoclonal antibody therapeutic targeting CD47, a protein overexpressed on many cancer cells which prevents them from being engulfed and eliminated by macrophage mediated phagocytosis.
The approval of Tibsovo was based on an open-label, single-arm, multicenter clinical trial (Study AG120-C-001) involving 174 patients with relapsed or refractory AML with an IDH1 miutation.
The researchers found that there were significantly fewer pain crises in the L-glutamine group than in the placebo group, with a median of 3.0 and 4.0, respectively.