Miscellaneous Hematological Agents
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.
Dilanubicel is a universal donor, off-the-shelf-, ex vivo expanded hematopoietic stem and progenitor cell investigational product that provides rapid, transient hematopoiesis while also inducing long-term immunologic benefits.
"Now, given the significant decrease in cases of Zika virus infection in the United States and its territories, we are moving away from testing each individual donation to testing pooled donations."
"Blood donations are currently being distributed to hospitals faster than donations are coming in - we need both new and current blood donors to make an appointment as soon as possible to help patients battling illness and injury," said Chris Hrouda, president of Red Cross Blood Services.
Glasdegib, an investigational oral smoothened (SMO) inhibitor, is a once-daily therapy that is thought to work by disrupting the Hedgehog pathway.
The sNDA is supported by data from the Phase 3 iNNOVATE (PCYC-1127) trial which assessed ibrutinib in combination with rituximab vs rituximab alone in 150 patients with previously untreated and relapsed/refractory WM.
The approval was based on data from the KEYNOTE-170 study, a multicenter, open-label, single-arm trial that included 53 patients with relapsed or refractory PMBCL.
ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) was a Phase 3 trial that evaluated the triplet regimen Kyprolis, lenalidomide, and dexamethasone (KRd) vs lenalidomide and dexamethasone (Rd) alone, in patients with relapsed or refractory multiple myeloma who received 1-3 prior regimens.
The new approval was based results from the Phase 3 MURANO trial which included 389 patients with CLL who had received ≥1 prior line of therapy.
"In this study on a large continuous nationwide claims database, we confirm the safety profile of oral propranolol in healthy children to be good," the authors write.
Since brodifacoum - a long-acting vitamin K-dependent antagonist, used as a rodenticide - was detected in drug and biologic samples from patients using synthetic cannabinoids, there have been 202 reported cases of coagulopathy in 9 states (mostly Illinois; N=164)
The researchers found that the MFS/ATR1a-null mice showed unabated aortic root enlargement and remained responsive to losartan, despite being hypotensive and resistant to AngII vasopressor effects.
Data were included for 2,821 children with 5,014 person-years. The researchers found that 18 percent of children received ≥300 days of antibiotics.
After completion of the initial bevacizumab treatment cycle, there was a significant reduction in epistaxis severity scores and RBC transfusion requirements.