2- Tuesday Pharmacy Practice News – 3rd August

1 – FDA Grants Orphan Drug Designation to Alrizomadlin for Stage IIB-IV Melanoma

• Significant progress has been achieved in recent years in the clinical treatment of patients with metastatic or unresectable melanoma, with therapies such as mitogen-activated protein kinase inhibitors and immunotherapies to help improve patients’ overall survival and quality of life.
• The FDA has granted Orphan Drug Designation (ODD) to alrizomadlin (APG-115, Ascentage Pharma) for the treatment of stage IIB-IV melanoma.
• This marks the fifth ODD granted to the drug, in addition to designations for the treatment of gastric cancer, acute myeloid leukemia, soft tissue sarcoma, and retinoblastoma, according to a press release.

Source: Pharmacy Times

2 – MicroRNA, AXL Gene Potentially Responsible for Drug Resistance in Certain Non-Small Cell Lung Cancers

• Investigators have found that a small percentage of epidermal growth factor receptor (EGFR) inhibitor-resistant cancer cells are present in certain patients with non-small cell lung cancers (NSCLCs), potentially explaining tumor regrowth in these patients, according to a study published in eLife.
• Mutations in the EGFR growth receptor occur in approximately 15% of NSCLCs, according to the study.
• The study results indicate that these drug-resistant cells rely on a different gene—AXL—for survival instead of EGFR.
• The investigators further observed that cancer cells could transition between drug-sensitive and drug-resistant states, and that when patients finish EGFR treatment, random modifications constantly occur in the remaining cells, which causes both types of cells to grow back.

Source: Pharmacy Times

3 – Johnson & Johnson Single-Shot COVID-19 Vaccine Elicits Both Humoral and Cellular Response, Protects Against Delta Variant

• Both the antibody and T cell immune responses generated by the Johnson & Johnson single-shot COVID-19 vaccine were stable through 8 months following immunization, according to the interim results of a phase 1/2a sub-study published in the New England Journal of Medicine.
• The results indicated that T cell responses—including CD8+ T cells, which seek out and destroy infected cells—persisted over the 8-month timeframe of the study, according to the authors.
• The ongoing phase 1/2a trial is a multi-center, randomized, double-blind, placebo-controlled study that aims to evaluate the safety, reactogenicity, and immunogenicity of the Janssen COVID-19 Vaccine.
• Data from the study suggested that 1 dose of the Johnson & Johnson COVID-19 vaccine resulted in the maturation of B cell response without further booster shots. Mature B cells produce antibodies that help to fight SARS-CoV-2.
• In combination with the T cell responses, these dual mechanisms of protection were capable of protecting against COVID-19, including disease caused by notable variants such as the Delta, Alpha, Beta, Gamma, Epsilon, and Kappa variants.
• This indicates an expansion of neutralizing antibodies over the 8 months of the study, according to the authors.

Source: Pharmacy Times

4- Clinical Pearl of the Day: SGLT2 Inhibitors and Glomerular Filtration Rate Cutoffs

Sodium-glucose transport protein 2 (SGLT2) inhibitors and glomerular filtration rate cutoffs:

• On empagliflozin (Jardiance) and GFR is below 30, empagliflozin should be discontinued.
• On dapagliflozin (Farxiga) and GFR is below 45, dapagliflozin should be discontinued.
• On canagliflozin (Invokana) and GFR is below 30, canagliflozin should be discontinued.
• Given their mode of action, which is heavily dependent on the glucose filtered load and therefore on GFR, the efficacy of SGLT2 inhibitors in reducing plasma glucose is expected to be decreased with decreasing renal function.
• Below a certain GFR, clinically significant reductions in plasma glucose cannot be achieved with SGLT2s.

Source: Pharmacy Times

5 – Pharmacists Can Help Patients Manage, Prevent Migraines

• Unlike other headaches, migraines are complex and can present differently at different times
• Patients who experience migraines may experience nausea, vomiting, difficulty concentrating, sensitivity to light or sound, and some may even experience an aura that proceeds the headache
• Community pharmacists can play an important role in the prevention and management of migraines, whether by helping them identify differences between a migraine and a severe headache or by providing medication management, according to a panel of experts in a recent Pharmacy Times Peer Exchange.
• Identifying whether patients are experiencing a migraine or a severe headache is often the first step when patients come to a community pharmacist with questions.

Source: Pharmacy Times

6 – Into the Unknown: What Might a Combined Influenza/COVID-19 Season Look Like This Fall?

• Ask the average person whether it feels like we are starting to get out of the woods on COVID-19 and most everyone would respond in the affirmative, despite some worrying trends in vaccine hesitancy and hospitalizations of young adults.
• Remember the flu? It’s practically nonexistent this year.
• The CDC has chosen to track Pneumonia-Influenza-COVID-19 (PIC) as a bundle of coded conditions for death and will likely continue to do so.
• Social distancing, wearing masks, washing hands, and getting the flu vaccine are all great ways to avoid getting influenza, at least until another strain comes around. Of course, doing the same for COVID-19 clearly had the same effect.

Source: Pharmacy Times

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