Oncology Drug Reference Sheet: Sacituzumab Govitecan-Hziy
Initially marketed in April 2020 for treatment of adults with metastatic triple negative breast cancer, sacituzumab govitecan-hziy (Trodelvy®) received an additional approval in 2021 for the treatment of patients with locally advanced or metastatic urothelial cancer with prior treatments.
FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations
On September 22, 2021, the U.S. Food and Drug Administration (FDA) granted emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine for use as a single booster dose administered at least six months after completion of the primary series in individuals aged 65 and older, individuals aged 18–64 at high risk for severe COVID-19, and individuals aged 18–64 whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk for serious complications of COVID-19 or severe COVID-19.
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IntegraDose Compounding Services Issues Voluntary Nationwide Recall of Cefazolin Injection Products Because of a Lack of Sterility Assurance
On September 21, 2021, the U.S. Food and Drug Administration (FDA) reported IntegraDose Compounding Services’ voluntary recall of nine lots of cefazolin 2 g in 20 ml syringe for injection and two lots of cefazolin 3 g in 100 ml 0.9% sodium chloride bag for injection because of a lack of sterility assurance resulting from compounding in a newly installed biologic safety cabinet without completing dynamic smoke study testing.
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Biden-Harris Administration Invests in Health Care for Rural Communities, Provides $19 Million for Telehealth Opportunities
Despite its now-widespread use, telehealth still poses barriers for many patients, such as limited access in rural areas and privacy concerns. In August 2021, the Biden-Harris administration announced the investment of billions of dollars to meet immediate COVID-19 needs and help improve hospital care to rural communities. The funding includes more than $19 million in telehealth to improve the initiative in rural and underserved communities.
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What the Evidence Says About Traditional Chinese Medicine Ma Zi Ren Wan for Constipation
A common and distressing symptom among patients with a variety of health diagnoses as well as the general population, constipation is characterized by reduced stool frequency, incomplete evacuation, straining, and a sense of anorectal blockage. Nearly 43%–58% of patients with cancer report constipation caused by a variety of factors, including organic, functional, or drug associated. Standard treatment options such as fiber supplements, laxatives, and stool softeners are not entirely effective and can cause adverse effects.
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U.S. Supreme Court Upholds ACA Again
After a decade and three legal challenges that culminated in another U.S. Supreme Court decision to uphold the law, the Patient Protection and Affordable Care Act ([ACA], commonly known as Obamacare) is currently established canon. On June 17, 2021, the Supreme Court of the United States (SCOTUS) ruled in favor of the defendants in the case of California et al. v. Texas et al., maintaining ACA’s constitutionality. It was a firm 7-2 decision.
FDA Approves Ruxolitinib for Chronic Graft-Versus-Host Disease
On September 22, 2021, the U.S. Food and Drug Administration (FDA) approved ruxolitinib (Jakafi®) for chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older.
FDA Approves Cabozantinib for Differentiated Thyroid Cancer
On September 17, 2021, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx®) for adult and pediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor (VEGFR)-targeted therapy and who are ineligible for or refractory to radioactive iodine treatment.
Antibiotics May Reduce Checkpoint Inhibitor Efficacy
Using antibiotics during treatment with immune checkpoint inhibitors may limit the therapy’s effect, according to study results published in the American Journal of Clinical Oncology.
FDA Grants Accelerated Approval to Tisotumab Vedotin-Tftv for Recurrent or Metastatic Cervical Cancer
On September 20, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisotumab vedotin-tftv (Tivdak™), a tissue factor-directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer whose disease has progressed on or after chemotherapy.