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.
Results showed an increased risk of bleeding with SRIs by 1.16-2.36 times with an even higher 3.17- to 10.9-fold risk with concomitant NSAIDs.
The Company is currently conducting a Phase 3 trial (APeX-2) and a long-term safety study (APeX-S) evaluating 2 doses of the treatment.
The pediatric approval was supported by evidence from studies in adults with additional safety and pharmacokinetics data from a single-arm trial of 50 pediatric patients with solid tumors treated with Granix for chemotherapy-induced neutropenia.
A comparative medication chart of thromboembolic disorder treatments in patients without DVT/PE.
List of medications indicated for the prophylaxis and/or treatment of deep vein thrombosis (DVT) / pulmonary embolism (PE) with usual adult dosage.
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 was based on data from 2 randomized, double-blind, placebo-controlled trials (L-PLUS 1 [N=97] and L-PLUS 2 [N=215]) involving patients with chronic liver disease who were undergoing an invasive procedure and had a platelet count <50 x 109/L.
The analysis also showed that the more severe the anemia was at baseline, the greater the response was to treatment with regard to hemoglobin changes.
The most commonly reported adverse events were gastrointestinal adverse events, mainly grade 1, especially in the 2 highest BCX7353-dose groups.
The approval was based on data demonstrating that the biosimilar product and the reference product are highly similar, and that there are no clinically meaningful differences between the 2 agents.
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.
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.
Researchers found "no clinically meaningful differences" in efficacy and safety between the biosimilar epoetin alfa-epbx and epoetin alfa.
"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 risk of a nonfatal GI bleeding event was 2.19 per 1,000 person-years in the baseline cohort, 1.77 in the non-high-risk cohort, and 1.61 in the nonmedication cohort.
Researchers related maximal ACT to the risk of major bleeding in 14,634 patients undergoing TR or TF PCI with unfractionated heparin monotherapy.
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 a randomized, single-blind, multicenter, dose-ranging, crossover study which evaluated the safety and efficacy of Cinryze in 12 pediatric patients (7 to 11 years old).
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.