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FDA approves Dabrafenib with Trametinib for pediatric gliomas

The US FDA has approved dabrafenib with trametinib for children aged 1 year or older who need systemic treatment for low-grade gliomas that have a BRAF V600E mutation. Dabrafenib/trametinib is the first systemic therapy approved for frontline treatment of low-grade, BRAF-mutated pediatric gliomas, the FDA said. Dabrafenib was given orally twice daily, and trametinib was given orally once daily. Children in the chemotherapy arm received a 10-week induction course followed by eight 6-week maintenance cycles.

Adverse effects: pyrexia (66%), rash (54%), headache (40%), vomiting (38%), musculoskeletal pain (36%), fatigue (31%), dry skin (31%), diarrhea (30%), nausea (26%), epistaxis and other bleeding events (25%), abdominal pain (24%), and dermatitis acneiform (23%). The more common grade 3 or 4 laboratory abnormalities were decreased neutrophil count (20%) and increases in alanine aminotransferase (3.1%) and aspartate aminotransferase levels (3.1%).

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FDA approves new drug for Hemophilia A

The US FDA has approved efanesoctocog alfa (Altuviiio), a first-in-class, high-sustained factor VIII replacement therapy for adults and children with hemophilia A. The product is used once a week and is indicated for routine prophylaxis and on-demand treatment to control bleeding episodes, as well as to control bleeding during surgery (perioperative management).

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FDA approves sacituzumab govitecan for HR+ metastatic breast CA

The US FDA approved a new indication for sacituzumab govitecan for patients with unresectable, locally advanced or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer after endocrine-based therapy and at least two additional systemic therapies for metastatic disease.

Adverse events: decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, decreased lymphocyte count, diarrhea, fatigue, nausea, alopecia, glucose elevation, constipation, and decreased albumin. Labeling for the agent carries a black box warning of severe or life-threatening neutropenia and severe diarrhea.

Dose: 10 mg/kg IV on days 1 and 8 of 21-day cycles until disease progression or unacceptable toxicity.

Sacituzumab govitecan was previously approved for unresectable, locally advanced or metastatic triple-negative breast cancer after two or more prior systemic therapies and locally advanced or metastatic urothelial cancer after platinum-based chemotherapy and either a PD-1 or PD-L1 inhibitor.

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FDA approves Pirtobrutinib for R/R mantle cell lymphoma

The US FDA approved pirtobrutinib (Jaypirca) for relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. Pirtobrutinib is the first and only non-covalent BTK inhibitor.

Dose: 200 mg once-daily

Adverse reactions: Fatigue, musculoskeletal pain, diarrhea, edema, dyspnea, pneumonia, bruising, decreased neutrophil counts, lymphocyte counts, and platelet counts.

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Two classes of drug appear effective for gastroparesis treatment

Two classes of drugs may be more effective than others for the treatment of gastroparesis, though the overall quality of evidence remains low to moderate and additional data are needed, according to a new report. Oral dopamine antagonists and tachykinin-1 antagonists appear superior to placebo. Only one drug, the dopamine antagonist metoclopramide, has US Food and Drug Administration approval for the treatment of gastroparesis (Gastroparesis is a chronic disorder which means delayed stomach emptying without a blockage).

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FDA approves first in class drug for Follicular Lymphoma

The US FDA has approved mosunetuzumab-axgb (Lunsumio) for use in patients with relapsed or refractory follicular lymphoma who have received at least two previous systemic therapies. This is a first-in-class bispecific antibody that is designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. Mosunetuzumab-axgb is administered as an intravenous infusion for a fixed duration, which allows for time off therapy, and can be infused in OPD.

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FDA approves a new drug for multi-drug resistant HIV-1

Lenacapavir is the first of a new class of drugs called capsid inhibitors to be FDA-approved for treating HIV-1. The drug blocks the HIV-1 virus protein shell and interferes with essential steps of the virus evolution. Lenacapavir is administered only twice annually, but it is also combined with other antiretrovirals. After the initial doses are completed — given both orally and via subcutaneous injection — the drug is administered by injection every 6 months. The injections and oral tablets of lenacapavir are estimated to cost $42,250 in the first year of treatment and then $39,000 annually in the subsequent years.

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Adagrasib approved for KRAS-Mutated NSCLC

The US FDA has approved Adagrasib (Krazati) for use in adults with KRAS G12C-mutated locally advanced or metastatic non–small cell lung cancer (NSCLC) that has progressed on at least one prior systemic therapy.

Dose: 600mg BD

Adverse reactions: Diarrhea, nausea, fatigue, vomiting, musculoskeletal pain, hepatotoxicity, renal impairment, dyspnea, edema, decreased appetite, cough, pneumonia, dizziness, constipation, abdominal pain, and QTc interval prolongation.

Laboratory abnormalities: Decreased lymphocytes, increased aspartate aminotransferase, decreased sodium, decreased hemoglobin, increased creatinine, and decreased albumin.

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ADA advises new BP, lipid targets for people with diabetes

New more aggressive targets for blood pressure and lipids are among the changes to the annual American Diabetes Association (ADA) Standards of Care in Diabetes 2023. The new definition of hypertension in people with diabetes is ≥ 130 mmHg systolic or ≥ 80 mmHg diastolic blood pressure, repeated on two measurements at different times. Among individuals with established cardiovascular disease, hypertension can be diagnosed with one measurement of ≥ 180/110 mmHg. The goal of treatment is now less than 130/80 mmHg if it can be reached safely.

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Potential new biomarker for early stage Alzheimer disease

Investigators found that levels of formic acid, a metabolic product of formaldehyde found in urine, were significantly higher in individuals with Alzheimer disease including those with subjective cognitive decline, which may indicate very early stages of the disorder. Urinary formic acid and formaldehyde are likely to be new biomarkers independent of the existing AD diagnostic criteria. Researchers also compared formic acid and formaldehyde levels across different AD stages and found significantly higher levels across all stages compared with people who had no cognitive decline. Levels were also higher in patients with AD than in patients with MCI and those with cognitive impairment and no MCI, as well as in those with poorer neurologic test scores.

Source: Frontiers
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