MESOTHELIOMA
First new regimen approved in 16 years
Nivolumab (Opdivo) in combination with ipilimumab (Yervoy) is the first drug regimen approved to treat mesothelioma in 16 years and the second FDA-approved systemic therapy for mesothelioma. The new regimen is indicated as a first-line treatment for adults with malignant pleural mesothelioma (MPM) that cannot be removed by surgery. Nivolumab and ipilimumab are both monoclonal antibodies that, when combined, decrease tumor growth by enhancing T-cell function.
MPM, a life-threatening cancer of the pleura caused by inhaling asbestos fibers, accounts for most mesothelioma diagnoses. Most patients have an unresectable tumor at diagnosis and the prognosis for most patients is poor.
In a clinical trial involving 605 patients, one group received I.V. infusions of nivolumab every 2 weeks with I.V. infusions of ipilimumab every 6 weeks for up to 2 years; the other group received platinum-doublet chemotherapy for up to six cycles. Patients who received the new combination therapy survived a median of 18.1 months versus a median of 14.1 months for patients receiving chemotherapy.
About 20,000 Americans are diagnosed with MPM each year, according to the FDA.
Source: US Food and Drug Administration. FDA approves drug combination for treating mesothelioma. News release. October 2, 2020.
MACULAR DEGENERATION
Benefit of anti-VEGF therapy "remarkable"
Neovascular age-related macular degeneration (nAMD) is the largest single cause of irreversible severe vision loss in high-income countries. Although it can be treated with vascular endothelial growth factor (VEGF) inhibitors, data on lifetime outcomes are limited. To determine visual acuity outcomes of anti-VEGF treatment for nAMD in both eyes for patients' remaining lifetime, researchers conducted a study based on real-world cohort data involving 3,192 patients with nAMD treated in routine eye clinics (over 67,000 visits) in Australia, New Zealand, and Switzerland. Patients received intravitreal anti-VEGF treatment at the treating physician's discretion. The main outcome and measure was visual acuity in both eyes over the remaining lifetime.
The results showed that anti-VEGF treatment was associated with preserved useful visual acuity in almost 20% of patients over their average remaining lifetime. Better long-term outcomes were associated with younger age at baseline and more injections during the first year of treatment.
"This is a remarkable outcome compared with outcomes without intervention, which lead to legal blindness within 3 years of disease onset in 80% of those affected," the authors write. "These findings underline the public health necessity of providing anti-VEGF treatment to persons in need."
Source: Finger RP, Puth M, Schmid M, Barthelmes D, Guymer RH, Gillies M. Lifetime outcomes of anti-vascular endothelial growth factor treatment for neovascular age-related macular degeneration. JAMA Ophthalmol. [e-pub October 15, 2020]
EBOLA VIRUS INFECTION
Monoclonal antibody regimen approved
Inmazeb, a combination of three monoclonal antibodies, is the first FDA-approved treatment for infection with Zaire ebolavirus (commonly called Ebola virus) in adult and pediatric patients. Ebola virus is one of four Ebolavirus species that can cause fatal human disease. It is transmitted through direct contact with blood, body fluids, or body tissues of infected people or animals, and by contact with contaminated surfaces, bedding, and clothing. Healthcare workers caring for infected patients are at high risk for infection.
Inmazeb combines atoltivimab, maftivimab, and odesivimab-ebgn. Each of these three antibodies binds to the glycoprotein on the surface of Ebola virus, preventing it from attaching to and entering cells.
Inmazeb was evaluated in a multicenter, open-label, randomized controlled trial in which 154 patients received Inmazeb as a single I.V. infusion and 168 patients received an investigational control. The primary efficacy endpoint was 28-day mortality. Of the 154 patients who received Inmazeb, 33.8% died after 28 days compared with 51% of patients in the control group.
The most common adverse reactions to Inmazeb were fever, chills, tachycardia, tachypnea, and vomiting; however, these are also common signs and symptoms of Ebola virus infection. Hypersensitivity and infusion-related adverse events have been reported; treatment should be halted if a hypersensitivity reaction occurs.
The FDA has granted orphan drug and breakthrough therapy designations for Inmazeb.
Source: US Food and Drug Administration. FDA approves first treatment for Ebola virus. News release. October 14, 2020.
GERIATRICS
Cannabis use emerging among older adults
Using a survey, researchers assessed cannabis use among 568 older adults visiting a geriatrics clinic in California, a state with a long history of legalized medical cannabis and a more recent history of legalized recreational use. They found that 15% reported using cannabis within the previous 3 years, and about half of these respondents reported using cannabis regularly (daily or weekly). Most used cannabis for medical purposes only. The most common targeted conditions or symptoms were pain/arthritis, sleep disturbance, anxiety, and depression. Among the other findings:
* Just over three-quarters reported cannabis as being "somewhat" or "extremely" helpful in managing one of these conditions, and with few adverse reactions.
* Lotions, tinctures, and smoking were the most common administration forms.
* About 60% used cannabis for the first time at age 60 or older.
* Over 90% said their family members know about their cannabis use, but only 41% said their healthcare provider knows.
The authors note that although healthcare professionals are generally supportive of cannabis use for medicinal purposes, they may have reservations based on limited evidence, potential safety issues, and product quality and effectiveness. "Incorporating scientifically sound information about cannabis in health professionals' curricula and ongoing professional education forums may help clinicians feel more comfortable discussing cannabis use with their patients," the authors write. "Including questions on cannabis use as part of medication reconciliation during regular ambulatory visits might also facilitate conversations with patients."
Source: Yang KH, Kaufmann CN, Nafsu R, et al. Cannabis: an emerging treatment for common symptoms in older adults. J Am Geriatr Soc. [e-pub Oct. 7, 2020]
DRUG MISUSE
FDA warns about the "Benadryl challenge"
The FDA has received reports of adolescents admitted to the ED after taking higher-than-recommended doses of diphenhydramine (Benadryl) in order to induce hallucinations. Dubbed the "Benadryl challenge," this practice has been encouraged in videos posted on the social media application TikTok. The FDA has asked TikTok to remove these videos from their platform.
Diphenhydramine overdose can lead to serious cardiac problems, seizures, coma, or even death. The FDA urges consumers, parents, and caregivers to store diphenhydramine and all other medications "up and away and out of children's reach and sight" to prevent accidental poisonings by children and misuse by teens, "especially when they are home more often due to the COVID-19 pandemic and may be more likely to experiment."
Source: US Food and Drug Administration. FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl). News release. September 24, 2020.