Article Archives - Page 9 of 20

Ficlatuzumab + chemo shows early promise in refractory AML

The combination of ficlatuzumab plus chemotherapy showed considerable early promise in relapsed/refractory acute myeloid leukemia (AML) in a small phase-1 study.

Ficlatuzumab is an investigational, first-in-class monoclonal antibody that binds to extracellular hepatocyte growth factor (HGF) to prevent it from activating MET signaling and stimulating tumor growth.

Febrile neutropenia was the most common adverse event with the ficlatuzumab/cytarabine combination. Serious adverse events occurred in two patients, and there was one death deemed unrelated to the investigational therapy.

Source: Reuters Health

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FDA approves spinal cord stimulation for diabetic neuropathy pain

The Food and Drug Administration has approved the first high-frequency spinal cord stimulation (SCS) therapy for treating painful diabetic neuropathy (PDN).

The approval is specific for the treatment of chronic pain associated with PDN using the Nevro’s Senza System with 10 kHz stimulation. It is intended for patients whose pain is refractory to, or who can’t tolerate, conventional medical treatment.

The 10 kHz device, called HFX, involves minimally invasive epidural implantation of the stimulator device, which delivers mild electrical impulses to the nerves to interrupt pain signal to the brain. Such spinal cord stimulation “is a straightforward, well-established treatment for chronic pain that’s been used for over 30 years,” according to the company, although this is the first approval of the modality specifically for PDN.

Source: Medscape

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China’s first human infection case with Monkey B virus dies

A Beijing-based veterinarian who was confirmed as China’s first human infection case with Monkey B virus (BV) has died. The 53-year-old male vet, who worked for an institution researching on non-human primates, showed early-onset symptoms of nausea and vomiting, a month after he dissected two dead monkeys. The virus, initially isolated in 1932, is an alphaherpesvirus enzootic in macaques of the genus Macaca.

B virus (Cercopithecine herpesvirus 1; BV) is a macaque α-herpesvirus that is similar to the herpes simplex viruses (HSV1 and HSV2) of humans. From an animal health standpoint, BV is not a serious problem in its natural macaque host. However, the fatal effect of zoonotic BV infection in humans has driven the effort to eliminate BV from research macaques. Historically, the case fatality rate in untreated human BV infection has been greater than 70%, a rate similar to untreated HSV encephalitis in humans.

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Three new drugs linked with ANCA-associated vasculitis

The overactive bladder treatment mirabegron (Myrbetriq) is one of three new drugs to be linked to cases of drug-associated antineutrophil cytoplasmic antibody-associated vasculitis (DA-AAV) according to pharmacovigilance data.

The other two drugs are the antiviral agent sofosbuvir (Sovaldi) and the tyrosine kinase inhibitor nintedanib (Ofev), which is indicated for chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.

Source: Medscape

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New drugs for migraine

Five recently approved acute migraine treatments were specifically noted: two small-molecule calcitonin gene-related peptide (CGRP) receptor antagonists — rimegepant and ubrogepant — along with the nonsteroidal anti-inflammatory drug celecoxib, the serotonin 5-HT1F agonist lasmiditan, and remote electrical neuromodulation (REN). Highlighted risks include serious cardiovascular thrombotic events in patients on celecoxib, along with driving impairment, sleepiness, and the possibility of overuse in patients on lasmiditan.

Regarding acute treatment overall, the statement recommended NSAIDs, nonopioid analgesics, acetaminophen, or caffeinated analgesic combinations — such as aspirin plus acetaminophen plus caffeine — for mild to moderate attacks. For moderate or severe attacks, they recommended migraine-specific agents such as triptans, small-molecule CGRP receptor antagonists (gepants), or selective serotonin 5-HT1F receptor agonists (ditans).

Source: Medscape

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Prasugrel better than Ticagrelor in ACS patients undergoing PCI

The ISAR-REACT 5 trial has demonstrated the superiority of prasugrel to ticagrelor for patients presenting with ACS. Ticagrelor and prasugrel are both potent inhibitors of the P2Y12 receptor, but their drug class and mechanism of action are different.

The new analysis included more than 3,300 patients, most of whom were men, with 1,676 in the ticagrelor arm and 1,701 in the prasugrel arm. The primary endpoint – a composite of all-cause death, myocardial infarction, or stroke at 12 months – was reached in 9.8% in the former group and 7.1% in the latter (hazard ratio, 1.41; P=0.005).

Source: Medscape

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FDA approves Finerenone for slowing CKD in T2DM

The FDA approved the anti-mineralocorticoid agent finerenone (Kerendia) for slowing the progression of chronic kidney disease in type 2 diabetes patients.

The first non-steroidal, selective mineralocorticoid receptor antagonist was approved to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes.

The most common adverse events in the trial were hyperkalemia (18% vs 9% for those on placebo), hypotension, and hyponatremia. Finerenone should therefore not be used if serum potassium is above 5.0 mEq/L. Serum potassium and eGFR should also be measured in all patients prior to and during treatment and should be dosed according to these measures.

Source: FDA

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Lenvatinib-Pembrolizumab combo promising in advanced kidney cancer

The combination of the multikinase inhibitor lenvatinib and the anti-PD-1 antibody pembrolizumab has “encouraging” antitumor activity and a manageable side effect profile and might be an option following immune-checkpoint inhibitor (ICI) therapy in patients with metastatic renal-cell carcinoma (RCC), researchers report.

Pembrolizumab and lenvatinib are active as monotherapies in RCC. The phase-1b/2 Study 111/KEYNOTE-146 trialists tested the combination in 145 patients with metastatic RCC. Two patients with non-clear-cell RCC were excluded from the efficacy analysis but included in the safety analysis.

Source: Reuters Health

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Study shows tocilizumab and sarilumab reduce COVID-19 deaths

Treating critically ill COVID-19 patients with arthritis drugs tocilizumab and sarilumab significantly improves survival rates and reduces the amount of time patients need intensive care.

The immunosuppressive drugs, Actemra, also known as tocilizumab, and Kevzara, also known as sarilumab, reduced death rates by 8.5 percentage points among patients hospitalised and severely ill with the pandemic disease.

Among hospitalised Covid patients, administering one of the drugs in addition to corticosteroids reduced the risk of death by 17 percent, compared to the use of corticosteroids alone.

In patients who were not on ventilators, the risk of progressing to mechanical ventilation or death was reduced by 21 percent, compared to the use of corticosteroids alone.

Severely ill COVID patients experience an immune system overreaction known as a “cytokine storm” that can cause severe organ damage and death.

Tocilizumab and sarilumab are used to treat rheumatoid arthritis, an autoimmune condition, by inhibiting the effects of interleukin (IL)-6, a type of protein called a cytokine that signals the body to mount an inflammatory response.

But previous research on whether IL-6 inhibitors can be useful against severe COVID have variously reported benefit, no effect, and harm.

This prompted the WHO to coordinate the new study that combined data from 27 randomized trials conducted across 28 countries.

Source: Journal of the American Medical Association

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Insulin-Pramlintide combo improves type 1 diabetes control

A novel investigational coformulation of prandial insulin and pramlintide improves blood glucose control and reduces body weight in people with type 1 diabetes, early research suggests.

The injectable product combines a novel human prandial (pre-meal) insulin (A21G) with the amylin analog pramlintide. The latter reduces post-meal glucose spikes by slowing gastric emptying, reducing postprandial glucagon production, and increasing satiety.

Source: Medscape