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In FDA Updates

FDA approves Setmelanotide for obesity in Bardet-Biedl Syndrome

The US FDA has approved Setmelanotide, a melanocortin-4 receptor (MC4R) agonist, is the first FDA-approved therapy for BBS, a rare genetic disorder that impairs a hunger signal along the melanocortin-4 receptor (MC4R) pathway.

Individuals with Bardet-Biedl Syndrome typically have obesity that starts at age 1 along with insatiable hunger (hyperphagia). Available weight management options are generally unsuccessful. Other symptoms may include retinal degeneration, reduced kidney function, or extra digits of the hands or feet.

The most common adverse reactions (with an incidence ≥ 20%) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection.

Source: Medscape
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In Article

Massive breakthrough as rectal cancer disappears in every patient in drug trial

Patients with locally advanced rectal cancer and tumors with deficient mismatch repair (dMMR) have shown a remarkable response to treatment with the programmed cell death-1 (PD-1) inhibitor dostarlimab (Jemperli).

So far, the study has involved only 12 patients, but all of them have had a clinical complete response to treatment. They continue to show no signs of cancer (during follow-up ranging from 6 to 25 months) and have not undergone surgery or had radiation and chemotherapy, which are the standard treatment approaches.

Dostarlimab is already approved by the US Food and Drug Administration for use in the treatment of recurrent or advanced endometrial cancer with dMMR. Rectal cancer is an off-label use.

All patients had mismatch repair-deficient stage 2 or 3 rectal adenocarcinoma. The authors note that these tumors respond poorly to standard chemotherapy regimens, including neoadjuvant chemotherapy. The median age of enrolled patients was 54 years and 62% were women.

Source: NEJM

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In Medical Cases

Madura foot case

History: A 50-year-old woman with painless swelling in her left foot. The swelling started after a banal penetrating injury on the sole of her left foot 23 years ago. X-rays images showed multiple osteolytic lesions of the tarsus.

a) Eumycetoma
b) Sporotrichosis
c) Chromoblastomycosis
d) Histoplasmosis
e) Lobomycosis

Answer:

Eumycetoma, also known as Madura foot.

Causes Madurella spp., Leptosphaeria senegalensis, Curvularia lunata, Pseudallescheria spp., Neotestudina rosatii, Acremonium spp. and Fusarium spp.

Symptoms: Swelling, weeping pus filled sinuses, deformity.

Diagnostic method Microscopy, biopsy, culture, medical imaging, ELISA, immunodiffusion, DNA sequencing

Differential diagnosis: Actinomycosis (Actinomycetoma)

Treatment Surgical debridement, antifungal medicines

Medication Itraconazole, posaconazole, voriconazole

Complications: Amputation

Prognosis Recurrence is common

Frequency Endemic in Africa, India and South America

Source: Wikipedia
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In FDA Updates

IN.PACT 018 Drug-Coated Balloon approved for PAD

The US FDA has approved the IN.PACT 018 drug-coated balloon (DCB) for the treatment of peripheral arterial disease.

The paclitaxel-coated balloon is indicated for percutaneous transluminal angioplasty of de novo, restenotic, or in-stent restenotic lesions up to 360 mm in length with vessel diameters of 4 to 7 mm, located in the superficial femoral and popliteal arteries.

The IN.PACT 018 DCB is built on the same technology as the IN.PACT Admiral DCB (0.035 inch guidewire compatible), but is engineered to cross tight lesions, provide better deliverability, and is 0.018 inch guidewire compatible.

Source: Medscape

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In FDA Updates

First Line for Esophageal Cancer is now Immunotherapy

Immunotherapy with nivolumab (Opdivo) is now approved in the United States for first-line use in the treatment of unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

The new approval for the drug, a programmed cell death ligand-1 (PD-L1) inhibitor, is for use in this patient population regardless of PD-L1 status. The indication also specifies that nivolumab is to be used together with chemotherapy (with a fluoropyrimidine- and platinum-containing regimen) or in combination with ipilimumab (Yervoy), an immunotherapy with a different mechanism of action.

Source: Medscape

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In Article

Rare monkeypox detected in UK: Check symptoms, treatment & other details

A patient was found to be infected with monkeypox virus in the United Kingdom, who traveled to the country from Nigeria.

Monkeypox is caused by monkeypox virus, a member of the Orthopoxvirus genus in the family Poxviridae. Monkeypox is a viral zoonotic disease that occurs primarily in tropical rainforest areas of Central and West Africa and is occasionally exported to other regions.

The incubation period (interval from infection to onset of symptoms) of monkeypox is usually from 6 to 13 days but can range from 5 to 21 days.

Monkeypox typically presents clinically with fever, rash and swollen lymph nodes.

Monkeypox virus is mostly transmitted to people from wild animals such as rodents and primates, but human-to-human transmission also occurs.
Monkeypox virus is transmitted from one person to another by contact with lesions, body fluids, respiratory droplets and contaminated materials such as bedding.

The clinical presentation of monkeypox resembles that of smallpox, a related orthopoxvirus infection which was declared eradicated worldwide in 1980.

Vaccinia vaccine used during the smallpox eradication programme was also protective against monkeypox. A new third generation vaccinia vaccine has now been approved for prevention of smallpox and monkeypox. Antiviral agents are also being developed.

Source: WHO

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In Article

Saliva test for diagnosing endometriosis

The prospective ENDO-miRNA study included saliva samples obtained from women with chronic pelvic pain suggestive of endometriosis. Exploratory procedures were performed to look for lesions. All the patients underwent either a laparoscopic procedure (therapeutic or diagnostic laparoscopy) and/or MRI imaging. For the patients who underwent laparoscopy, diagnosis was confirmed by histology. For the patients diagnosed with endometriosis without laparoscopic evaluation, all had MRI imaging with features of deep endometriosis.

The respective sensitivity & specificity for the diagnostic miRNA signature were 96.7%, 100% respectively.

The study’s results support the use of a saliva-based miRNA signature for diagnosing whether a patient is discordant/complex (chronic pelvic pain suggestive of endometriosis and both negative clinical examination and imaging findings) or has early-stage or advanced-stage endometriosis.

Source: Medscape

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In Medical Cases

Langerhans-cell histiocytosis case

History: A female infant delivered at term had a “blueberry muffin” rash at birth. Laboratory tests and imaging studies were normal. Skin biopsy showed a dense infiltrate of cells with kidney-shaped nuclei and positive S100+ and CD1a+ on immunohistochemistry. What is the most likely diagnosis?

Answer:

Langerhans cell histiocytosis (LCH) is an abnormal clonal proliferation of Langerhans cells, abnormal cells deriving from bone marrow and capable of migrating from the skin to lymph nodes.

Symptoms range from isolated bone lesions to multisystem disease. LCH is part of a group of syndromes called histiocytoses, which are characterized by an abnormal proliferation of histiocytes.

The disease has gone by several names, including Hand–Schüller–Christian disease, Abt-Letterer-Siwe disease, Hashimoto-Pritzker disease (a very rare self-limiting variant seen at birth) and histiocytosis X, until it was renamed in 1985 by the Histiocyte Society.

Diagnosis: Assessment of endocrine function and bone marrow biopsy is also performed when indicated. S-100 protein, CD1a, langerin (CD207).

Treatment: Radiation therapy or chemotherapy

Source: NEJM, Wikipedia
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In FDA Updates

FDA approves new immunotherapy for metastatic melanoma

The FDA approved a combination nivolumab/relatlimab-rmbw immune checkpoint inhibitor (Opdualag) for unresectable or metastatic melanoma in adults and children 12 years or older.

Dose: 480 mg nivolumab + 160 mg relatlimab IV every 4 weeks.

Adverse effects: Musculoskeletal pain, fatigue, rash, pruritus, and diarrhea were the most common adverse reactions with combination nivolumab/relatlimab, occurring in 20% or more of RELATIVITY-047 trial participants. Adrenal insufficiency, anemia, colitis, pneumonia, and myocardial infarction were the most frequent serious adverse reactions, but each occurred in less than 2% of patients. There were three fatal adverse events in the trial due to hemophagocytic lymphohistiocytosis, acute lung edema, and pneumonitis.

Source: BMS
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In Medical Cases

Ehlers Danlos Syndrome case

A 20-year-old male presented to an outpatient headache clinic with a 10-year history of headache, which had become daily over the past 3 months and awakened her in the middle of the night. Past history also revealed chronic musculoskeletal pain, syncope, fatigue, and hypermobility of joints.

Ehlers–Danlos syndromes (EDS) are a group of thirteen genetic connective-tissue disorders that are in the current classification, with a fourteenth type discovered in 2018.

Symptoms may include loose joints, joint pain, stretchy velvety skin, and abnormal scar formation. These may be noticed at birth or in early childhood.

Complications may include aortic dissection, joint dislocations, scoliosis, chronic pain, or early osteoarthritis.

EDS occurs due to variations of more than 19 genes that are present at birth.[1] The specific gene affected determines the type of EDS. Some cases result from a new variation occurring during early development, while others are inherited in an autosomal dominant or recessive manner. Typically, these variations result in defects in the structure or processing of the protein collagen.

Diagnosis is often based on symptoms and confirmed with genetic testing or skin biopsy but people may initially be misdiagnosed with hypochondriasis, depression, or chronic fatigue syndrome.

No cure is currently known and treatment is supportive in nature. Physical therapy and bracing may help strengthen muscles and support joints. While some forms of EDS result in a normal life expectancy, those that affect blood vessels generally decrease it.

Source: Wikipedia
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