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  3. Refractory Multiple Myeloma- New FDA Approved Treatment 2022
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Refractory Multiple Myeloma- New FDA Approved Treatment 2022

By Ipshita Ghoshal| Last Updated at: 19th July '24| 16 Min Read

Multiple myeloma is one of the rarest cancers which grows in plasma cells in blood. In 2022, an estimated 34,470 cases of multiple myeloma were recorded in the United States. The death toll went up to 12,640 in the United States. Only 55% of people can survive up to 5 years after a cancer diagnosis. Most people struggle to live that long after being diagnosed with multiple myeloma.

According to the International Myeloma Foundation, relapses of multiple myeloma are common. The majority of patients experience remissions and relapses numerous times over the course of their illness.

The initial remission stage may last two to three years or longer for those with no additional risk factors.

According to a study in 2016, relapse rates in 511 patients with multiple myeloma after therapy from 2006 to 2014 were examined.

16 percent of the individuals had an early relapse within a year. But 84% either experienced a relapse within a year or had none at the time of the follow-up.

Researchers keep on studying the disease to develop various refractory multiple myeloma treatments to increase the relative survival rate of patients.

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More About: New Multiple myeloma relapse treatment

On 25th October 2022, the FDA approved a new treatment for relapsed refractory multiple Myeloma. Tecvayli (Teclistamab) got accelerated approval from the FDA. Tecvayli is approved for those who did not respond positively to four or more treatment cycles.

As per the FDA, this is the first BCMA-directed CD3 T-cell engager drug. This drug for myeloma relapse works by sticking to certain kinds of T cells that attack the cancer cells after finding them.

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The approval of Tecvayli (Teclistamab)

Teclistamab was evaluated in the study named MajesTEC-1. The study sample comprised 110 patients who had already received three prior therapies. The study's main objective was to determine the overall response rate and the percentage of patients who showed reduced symptoms of relapsed multiple myeloma. 

After the study, it was found that the overall response rate was 61.8%. In 90.6% of the patients, the positive response lasted more than six months. The positive response lasted for more than nine months in patients with excellent ORR. 

Hence Tecvayli was granted accelerated approval.


 

What are the adverse effects of Tecvayli?

There are a few side effects linked to Tecvayli, as observed among 20% of the patients who were administered Tecvayli during the Clinical study:


 

Safety information concerning Tecvayli

  • Tecvayli has a Boxed Warning for cytokine release syndrome, a disease in which the body releases an excessive amount of the inflammatory proteins known as cytokines.
  • Hepatotoxicity, infections, neutropenia, hypersensitivity, and embryo-fetal toxicity are among the warnings and precautions related to Tecvayli. 

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References:

https://pubmed.ncbi.nlm.nih.gov/35560063/

https://www.myeloma.org/treatments-subsequent-relapse

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5541860/

https://www.webmd.com/cancer/multiple-myeloma/refractory-multiple-myeloma


 

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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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Answered on 8th Mar '25

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