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 in 2023, where she produces written content covering multiple disease states.

She has a BA in journalism from Seton Hall University. You can connect with Brooke on 

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Today, the FDA approved roflumilast cream 0.15% (Zorvye; Arcutis Biotherapeutics) for the treatment of mild to moderate atopic dermatitis in patients 6 years and older.

FDA Approves Roflumilast for Patients 6 Years and Older With Atopic Dermatitis

Metformin use is linked to improved survival rates in patients with ovarian cancer, particularly among those with diabetes and serous cancers, though further research is needed to confirm these findings.

Metformin Use Linked to Better Survival Rates in Patients With Ovarian Cancer

Cameron Santoro is an associate editor for 

), AJMC.com, and The Center for Biosimilars

Results found nail changes in patients with alopecia areata (AA) can occur before, after, or independent of hair loss with the most common nail problems including pitting, ridging, and white spots. 

Nail Changes in Alopecia Areata: Review of Manifestations, Diagnosis, Management Strategies

Kim Zynn, vice president of UPMC Health Plan's provider network and development relations team, shares how physicians can become LGBTQIA+ affirming providers, which is designated within the health plan.

Frameworks for Advancing Health Equity: LGBTQIA+ Affirming Provider Designation

The American Journal of Managed Care provides insights into the latest news and research in managed care across multimedia platforms.

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A high-risk cohort of beneficiaries with chronic kidney disease (CKD) stage 3 have a profile similar to patients with CKD stages 4 and 5, indicating potential benefit of earlier nephrology intervention.

Identifying Chronic Kidney Disease Stage 3 With Excess Disease Burden

This article has been updated to reflect a revised target action date.

FDA has accepted Bristol Myer Squibb’s biologics license application (BLA) for its subcutaneous (SC) formulation of the nivolumab, which company officials say has the “potential” to be the first PD-1 inhibitor administered by subcutaneous injection if approved by its target action date, which has been advanced to December 29, 2024.

Sold as Opdivo, the therapy is formulated with hyaluronidase to create subcutaneous (SC) nivolumab. According to a BMS statement, the BLA covers all previously approved indications for use of intravenous (IV) nivolumab as a monotherapy in adult solid tumors, and all approvals for monotherapy as a maintenance therapy following use of the combination nivolumab plus ipilimumab (Yervoy) or combinations with chemotherapy or cabozantinib (Cabometyx).

Although some warn it’s too soon to say whether the shift to SC nivolumab will be a game-changer, leaders from BMS are enthusiastic about the BLA.

“We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” Gina Fusaro, PhD, vice president, global program lead, BMS, said in the statement. “[Nivolumab] is a foundational PD-1 inhibitor approved for many different types of cancer, and our continued investment in research that puts patients first remains a priority.

“If approved by the FDA, the subcutaneous administration of nivolumab would provide patients and their physicians with a new option that delivers the same well-known benefits as IV [nivolumab] but with the improved convenience of an injection administered in 3-5 minutes rather than a 30-to-60-minute infusion.”

The BLA is based on results from CheckMate-67T (NCT04810078), a phase 3 randomized trial that compared SC nivolumab and IV nivolumab in patients with advanced or metastatic clear cell renal cell carcinoma who had received prior systemic therapy. A total of 495 patients were evaluated. Coprimary endpoints are time-averaged serum concentration over 28 days and trough serum concentration at steady-state of SC nivolumab vs IV nivolumab. A key secondary endpoint is objective response rate (ORR).

Results were presented earlier this year at the 2024 

American Society of Clinical Oncology Genitourinary Cancers Symposium

 (ASCO GU), where data showed the study met both coprimary pharmacokinetic endpoints and its secondary endpoint of ORR, with response rates of 24.2% (95% CI, 19.0%-30.0%) for subcutaneous nivolumab vs 18.2% (95% CI, 13.6%-23.6%) for IV nivolumab.

A key advantage of subcutaneous nivolumab, and this administration route generally, is the rapid time to give patients the drug. It only takes an average of 5 minutes to administer subcutaneous nivolumab, compared with 30 minutes for IV administration.

The possibility of faster administration times—without the need for an infusion center—could make the PD-1 inhibitor available to patients for whom access is difficult, including those in rural areas, an expert told the National Cancer Institute (NCI) earlier this year.

“Subcutaneous immunotherapy is exciting on many fronts,” Mark Ball, MD, a kidney cancer expert in NCI’s Center for Cancer Research said in March. “We don't know if this is going to end up being a game changer or not, but it definitely has potential.”

1. Bristol Myers Squibb announced updated action date by the U.S. Food and Drug Administration for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. BMS website. Updated and accessed May 21, 2024. 

2. U.S. Food and Drug Administration accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase). News Release. Bristol Myers Squibb. May 8, 2024. Accessed May 6, 2024. https://news.bms.com/news/details/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

3. George S, Bourlon MT, Chacon MR, et al. Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T. J Clin Oncol. 2024;42(suppl 4). doi:0.1200/JCO.2024.42.4_suppl.LBA360

4. Jaber N. Nivolumab injections could make treatment easier for more people with cancer. National Cancer Institute. March 13, 2024. Accessed May 9, 2024. 

https://www.cancer.gov/news-events/cancer-currents-blog/2024/kidney-cancer-subcutaneous-nivolumab

Some experts believe offering a subcutaneous version of nivolumab could make PD-1 inhibitors available to new groups of patients who currently lack access, such as those in rural areas.

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FDA Accepts Nivolumab Subcutaneous Injection Application, With Potential to Boost Access to PD-1 Inhibitors

Asthma is a chronic inflammatory disorder of the airways, often resulting in recurrent attacks of wheezing, breathlessness, chest tightness, coughing, and excess mucus production.

 Experts suggest patients with asthma manage their disorder by avoiding environmental triggers but with the increasing issue of climate change, specifically air pollution, exposure can be difficult to avoid.

Common environmental asthma triggers include pollen allergies either from trees, grasses, hay, or ragweed.

 High pollen count, especially during the spring and fall, are considered major triggers for patients with asthma and are advised to avoid time outside.

Significant changes in the weather, cold air, and humidity are potential triggers for patients with asthma as well. Ultimately, patients with asthma have their own unique triggers but most, if not all, are associated with the environment around them.

On average, asthma is responsible for 5000 deaths and almost 50,000 hospitalizations annually.

 In a National Health and Nutrition Examination Survey from 1999 to 2020, asthma impacts about 8.7% of Americans. Patients who identified as female had greater prevalence (64%) than those who identified as male (36%).

 where we explore climate change exacerbations that impact the environmental triggers faced by those with asthma.

Our series, titled “A Breathtaking Crisis, Climate Change Worsens Asthma” will shed light on the effects of climate change over the past few years. The 2-part series kicks off by exploring the environmental triggers patients with asthma endure.

 Mainly, air pollution from motor vehicle traffic, diesel exhausts, ozone smog, nitrogen oxides, and sulfur dioxides are adding to the damage of the Earth’s atmosphere and the lungs of patients with asthma.

In part 2, focus is shifted onto the impacts climate change causes for underserved communities and proposes potential solutions as the effects worsen.

Climate change is amplifying existing environmental triggers for asthma, particularly air pollution and pollen production. This disproportionately harms underserved communities with limited resources who already face higher asthma prevalence.

Asthma, though incurable, can be managed with medication and through the identification of environmental triggers.

 In addition to air pollution factors, higher atmospheric air temperatures and increased frequencies of heat waves are causing socioeconomic burdens and interfere with majority of the population.

Bronchial asthma is significantly affected by the growing prevalence of pathophysiological impacts on the human body that reflect anthropogenic factors and lifestyle changes.

 The growth patterns of allergen species can often act synergistically with air pollutants and the exposure to high temperature environments, often impacting respiratory mucosal homeostasis.

Asthma is worsening under the effects of climate change, such as air pollution and pollen production, especially for underserved populations.

Austin Campbell, PhD

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