Yescarta, a CD19-directed genetically modified autologous T cell immunotherapy, is indicated for use in large B-cell lymphoma including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
The researchers found that patients who received oral antibiotics and MBP had a lower overall SSI rate than those who received MBP only (8 versus 27%; P=0.03).
There was a 6.2-fold difference in thyroidectomy rates across U.S. regions (range, 22 to 139 per 100,000 Medicare beneficiaries).
The researchers found that there were correlations for acute lymphoblastic leukemia, high CD19+ cells in bone marrow, high CAR-T cell dose, cytokine release syndrome, and pre-existing neurologic comorbidities with elevated risk of neurologic adverse events.
Apalutamide, an investigational, next generation oral androgen receptor inhibitor, was assessed for safety and efficacy in the Phase 3 pivotal trial, ARN-509-003 (SPARTAN), which the NDA is based on.
The researchers recommend that clinicians provide counseling on sun protection behaviors for anyone with fair skin aged 6 months to 24 years, including parents of young children with fair skin (B recommendation).
The FDA granted accelerated approval of Alunbrig, a kinase inhibitor, for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
The researchers found that the use of propranolol at the time of diagnosis was significantly inversely linked to melanoma recurrence after adjustment for known prognostic factors, with about an 80% reduction in risk for propranolol users.
African-American patients harbored significantly more tumor-infiltrating lymphocytes than European Americans among early-stage (I to II), but not late-stage (III to IV), patients.
The overall response rate based on modified RECIST was 18.2% with complete response rate of 3.2% and partial response rate of 14.9%.
The overall response rate among patients was 13.3% (95% CI: 8.2, 20.0) with a complete response seen in 1.4% and partial response in 11.9%.
The study enrolled a total of 372 patients with MF and SS who were randomized to either receive mogamulizumab or vorinostat.
The researchers found that administration of hdc+ Lactobacillus reuteri in the gut resulted in luminal hdc gene expression and production of histamine in the intestines of Hdc−/− mice.
BMI was positively correlated with ER+/PR+ and ER−/PR− subtype risks, with a significant association only seen for ER+/PR+ subtypes.
The 16-week study (n=115) enrolled patients with histopathologically-confirmed neuroendocrine tumors and a history of carcinoid syndrome who were treatment-naive or stable on another somatostatin analog.
The approval was based on evidence from animal study data, human pharmacokinetic and pharmacodynamics data, and clinical immunogenicity data which demonstrated Mvasi is a biosimilar to Avastin.
The researchers found that there was an association for multivitamin use before diagnosis with reduced symptoms of CIPN (CTCAE-adjusted odds ratio, 0.6 [95% confidence interval, 0.42 to 0.87]; FACT/GOG-Ntx-adjusted OR, 0.78 [95% confidence interval, 0.61 to 1]).
For women aged 21 to 29 years, the USPSTF recommends screening for cervical cancer with cervical cytology alone every 3 years. For women aged 30 to 65 years, the USPSTF recommends screening every 3 years with cervical cytology alone or every 5 years with hrHPV testing alone (A recommendation).
"If [the sNDA is] approved, Cabometyx will offer an important new alternative for the treatment of patients with previously untreated advanced RCC," said Michael M. Morrissey, PhD, President and CEO of Exelixis.
In the United States, Canada, and United Kingdom, physicians do not have the legal duty to assist unless there is a prior patient-physician relationship.
The researchers found that the estimated 3-year rate of relapse-free survival was 58% in the combination-therapy group and 39% in the placebo group at a median follow-up of 2.8 years.
The researchers found that the 12-month rate of recurrence-free survival was 70.5 and 60.8% in the nivolumab and ipilimumab groups, respectively, at a minimum follow-up of 18 months.
The researchers found that 2.9% of the 347 patients treated with anti-PD-1 monoclonal antibodies developed subacute onset of neurological complications.
A significantly higher response rate was seen with durvalumab versus placebo (28.4 versus 16.0%), with a longer median duration of response (72.8 versus 46.8% of patients had ongoing response at 18 months).