The FDA granted accelerated approval in 2019 to enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before or after surgery, or in a locally advanced or metastatic urothelial cancer setting.
Milind Javle, PhD, professor of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center, discussed the importance of the FDA’s expedited approval process for infigratinib in the treatment of previously treated locally advanced or metastatic cholangiocarcinoma.
Mikhail Kosiborod, MD, cardiologist and vice president of research at Saint Luke's Health in Kansas City, discussed the implications of the DARE-19 trial results assessing dapagliflozin as a treatment for patients with type 2 diabetes hospitalized with COVID-19.
The companies say COVID-19 booster shots may be necessary, although the FDA and CDC have disagreed.
The data show that the maximum tolerated dose of rigosertib in combination with nivolumab was not reached in the 3 cohorts of the trial’s dose-escalation phase in patients with advanced KRAS-positive metastatic lung adenocarcinoma.
The preprint submitted by the company consists of a new analysis from blood samples obtained from a subset of participants in the phase 3 ENSEMBLE study.
The new results add to earlier findings from the EMPEROR-Reduced phase 3 trial, which found that empagliflozin reduced the combined relative risk of cardiovascular death or hospitalization for heart failure by 25% compared to placebo.
A retrospective case series published in JAMA Cardiology found that although there are rare instances of myocarditis—inflammation of the heart muscle—in younger men following COVID-19 vaccination, the greater risk for heart damage and death comes from COVID-19 infection.
The investigators also found that the risk of spreading disease may be lower amongst those with breakthrough infections.
The messages offered alternatives to these prescription drugs and offered education for providers that is designed to lead to a change in medication.
This risk was not seen in older adults with dentures, which could indicate that the cognitive decline associated with tooth loss could be mitigated through timely and effective treatment with dentures, according to the investigators.
Mikhail Kosiborod, MD, cardiologist and vice president of research at Saint Luke's Health in Kansas City, discussed what some of the adverse events experienced by patients were, and how patients were able to handle them.
Milind Javle, PhD, professor of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center, discussed the importance of the FDA’s expedited approval process for infigratinib in the treatment of previously treated locally advanced or metastatic cholangiocarcinoma.
The keys to this recovery will be innovation and collaboration, according to Craig Dolan, PharmD, MBA, of McKesson RxO.
Study’s secondary endpoints were also met, including the achievement of endoscopic improvement, histologic-endoscopic mucosal improvement, and corticosteroid-free clinical remission at week 52.
Despite significant medical advancements related to HIV treatment and quality of life, the risk of suicide in patients is high and health care providers should prioritize mental health screenings in this population.
Mikhail Kosiborod, MD, cardiologist and vice president of research at Saint Luke's Health in Kansas City, discussed why the research assessing dapagliflozin advanced from cardiorenal effects to prevention and organ protection.
Milind Javle, PhD, professor of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center, discussed how the US FDA evaluated the application for infigratinib to expedite the approval process for treatment of previously treated locally advanced or metastatic cholangiocarcinoma.
Recurrent C. diff infections were observed in 16% of patients who received bezlotoxumab, compared with 29% of patients who received standard of care alone.
The 5-year overall survival was 18% in the CPX-351 group compared to 8% in the standard chemotherapy group.
Investigators have identified metabolic and glycomic signatures in blood samples of post-treatment controllers, a rare population of HIV-infected individuals who can naturally sustain viral suppression after antiretroviral therapy.
Milind Javle, PhD, professor of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center, discussed the dosing and treatment cycle during the trial assessing infigratinib for the treatment of previously treated locally advanced or metastatic cholangiocarcinoma.
Mikhail Kosiborod, MD, cardiologist and vice president of research at Saint Luke's Health in Kansas City, discussed why the results of the DARE-19 trial are important to the field, especially during the COVID-19 pandemic.
The approval is based on results from the phase 2 KEYNOTE-629 trial, which found an objective response rate of 50% in adults with recurrent, metastatic, or locally advanced cutaneous squamous cell carcinoma.
Milind Javle, PhD, professor of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center, discussed the safety profile of infigratinib for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma.
Panzyga is indicated for the treatment of primary humoral immunodeficiency, chronic inflammatory demyelinating polyneuropathy, and chronic immune thrombocytopenia.
Although the pharmaceutical and biopharma industries must maintain reasonable profitability, they have a moral duty to society.
Mikhail Kosiborod, MD, cardiologist and vice president of research at Saint Luke's Health in Kansas City, discussed the findings around the safety profile of dapagliflozin in patients with and without type 2 diabetes hospitalized with COVID-19 during the DARE-19 trial.
Milind Javle, PhD, professor of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center, discusses the eligibility requirements for patients included in the phase 2 trial results that led to the FDA approval of infigratinib.
Factors that may have contributed to the screening declines include site closures and temporary pausing of services.
