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  3. FDA Approved New Blood Cancer Treatment: Breakthrough Therap...
  • Cancer
  • Blood Cancer Treatment

FDA Approved New Blood Cancer Treatment: Breakthrough Therapy

By Ipshita Ghoshal| Last Updated at: 23rd Mar '24| 16 Min Read

Imagine undergoing a transplant procedure and being informed that you can develop a chronic disease, even a life-threatening one. And if this is your child who is younger than 12, you would have certainly been disappointed that there was no effective treatment for the disease. 

It is indeed heartbreaking. This new medication is a relief for all the patients and their parents because it has been proven effective against cGVHD.


More about the New Blood Cancer Treatment

On 24 August 2022, the FDA approved Imbruvica for treating graft vs. host disease in pediatric patients. This medication is indicated for treating children aged more than one year and less than 12 years.

Imbruvica has become the first-ever medication approved by the FDA for treating blood cancer in pediatric patients.

Along with the Imbruvica tablets, an oral suspension formulation is also approved by the FDA. Ibrutinib's oral suspension is available in a 150 ml bottle containing 70 mg of Ibrutinib. 

Ibrutinib has a low toxicity profile and brings a new ray of hope for patients with hematologic cancer, mainly older adult patients.

Imbruvica inhibits the multiplication of abnormal B cells and helps treat this hazardous ailment. Imbruvica works by blocking Bruton's tyrosine kinase (BTK) protein. BTK protein helps normal B cells and cancer cells grow and spread.

 

The effectiveness of Imbruvica was evaluated in a study named iMagine. The study consisted of 47 patients aged more than one year and less than 22 years who had cGVHD.

After the study was completed, it was found that the overall response rate was 60% in both groups. 4% of the patients showed a completely positive response, and 55% showed a partial response to the treatment when administered with Inbruvica. The group administered with a Placebo showed poor response to the disease. 


Side effects associated with Imbruvica 

Some of the adverse effects that were recorded during the clinical study of Imbruvica are as follows:

  • Anemia 
  • Musculoskeletal pain
  • Pyrexia 
  • Diarrhea
  • Pneumonia
  • Abdominal pain
  • Stomatitis
  • Thrombocytopenia
  • Headache


Safety information while using Imbruvica

While taking Imbruvica, it is advised that you keep in mind the following points:

  • Do not take Imbruvica along with any other anticoagulant or antiplatelet agents. Taking them at the same time poses a risk of severe bleeding.
  • Imbruvica may cause certain bacterial, viral, or fungal infections, which may be fatal or non-fatal.
  • Patients who have cardiac comorbidities or preexisting hypertension are at risk of having cardiac failure or cardiac arrhythmias. 
  • People with hypertension may take Imbruvica after proper consultation as it may increase hypertension in such patients.

References:

https://www.ons.org/

https://www.empr.com/home/news/

https://www.prnewswire.com/news-releases/

https://www.jnj.com/u-s-fda-approves-imbruvica-ibrutinib-as-first-and-only-btki-treatment-for-pediatric-patients-with-chronic-graft-versus-host-disease

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Question and Answers

. Heterogeneous Soft Tissue Nodule in the Right Lower Lobe (RLL) Size: 14 x 8 mm This nodule is described as heterogeneously enhancing, which suggests it may have varying levels of blood flow or different tissue densities within it. This could be indicative of a tumor. 2. Air Space Opacification in the Right Upper Lobe (RUL) Finding: There is patchy air space opacification with interlobular septal thickening in the posterior segment of RUL. This could represent infection, inflammation, or more concerningly, metastatic disease or lung cancer causing these changes. 3. Left-sided Pleural Effusion and Subsegmental Atelectasis Pleural Effusion: Mild left-sided pleural effusion is noted. Pleural effusion can occur in the context of metastatic disease or cancer. Atelectasis: This refers to partial lung collapse, which may occur when there is a mass obstructing the airflow or due to pleural fluid. 4. Enlarged Mediastinal and Hilar Lymph Nodes Lymphadenopathy: There are multiple enlarged and necrotic lymph nodes, most notably in the right hilar region, with the largest measuring 35 x 25 mm. Enlargement and necrosis of lymph nodes can be a sign of metastatic spread. The presence of enlarged lymph nodes in the mediastinum and hilum is typical of malignancy spreading beyond the primary lung site. 5. Liver Lesion Size: 14 x 13 mm lesion in the right hepatic lobe, which is well-defined and peripherally enhancing. A hypodense lesion could indicate a metastatic tumor, especially since it shows peripheral enhancement, a characteristic of some types of metastases. 6. Skeletal Lesions Multiple Lesions: There are mixed lytic and sclerotic bony lesions, some with soft tissue components. These lesions involve the vertebrae, ribs, glenoids, sternum, sacral ala, iliac bones, and femur. Soft Tissue Components: Some of the lesions, such as those in the ribs and iliac bones, have a soft tissue component, which suggests more advanced involvement, possibly indicating metastases. 7. Other Findings: No signs of emphysema, bronchiectasis, or pneumothorax were noted, which is reassuring as it reduces the likelihood of certain types of lung diseases. The liver, spleen, pancreas, kidneys, urinary bladder, and prostate all appear normal on imaging, which helps to rule out major issues in these organs. Impression: The findings of a heterogeneously enhancing solitary pulmonary nodule in the right lung, with associated hilar and mediastinal lymphadenopathy, along with a hepatic lesion and extensive skeletal involvement (with mixed lytic and sclerotic lesions), strongly raise concern for metastatic disease, most likely originating from the lung. The primary lung cancer is a potential consideration, though other primary sites are also possible. Next Steps: Histopathological correlation: This means a biopsy or tissue sample should be taken from one of the lesions (pulmonary, hepatic, or bone) to confirm whether the lesions are malignant and, if so, to identify the type of cancer. This will help determine the best course of treatment. The overall picture suggests a metastatic malignancy, likely of pulmonary origin, but further investigations and biopsy are essential to establish a definitive diagnosis and treatment plan.

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