July 23, 2024

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FDA approved TheraSphere yttrium-90 therapy for liver cancer

FDA approved TheraSphere yttrium-90 microsphere therapy for liver cancer


FDA approved TheraSphere yttrium-90 microsphere therapy for liver cancer.   

As liver cancer is highly malignant and its early symptoms are not obvious, many people are diagnosed in the middle and late stages and the prognosis is very poor. Is there really no hope for advanced liver cancer?


The good news is that the FDA recently approved TheraSphere yttrium-90 microsphere therapy for the treatment of patients with hepatocellular carcinoma (HCC, the most common type of liver cancer).

This therapy is the first and currently only interventional radiotherapy approved in the United States for the treatment of advanced hepatocellular carcinoma.



FDA approved TheraSphere yttrium-90 microsphere therapy for liver cancer




▌Yttrium-90 microspheres: a “weapon” for the treatment of advanced liver cancer

Dr. Michael Castro, an expert on oncology precision medicine from the Good Doctor Medical Network (he has been awarded the “Top Doctors in the United States” for many times), said that at present, advanced liver cancer is not curable but still treatable.


Common treatments for liver cancer mainly include: surgical treatment (surgical resection, liver transplantation), radiotherapy, chemotherapy, interventional therapy (including: interventional chemotherapy, interventional radiotherapy), targeted therapy, immunotherapy, etc.


Yttrium-90 microsphere therapy is a low-toxicity selective interventional radiotherapy (SIRT) method, which contains millions of microspheres containing the radioactive element yttrium (Y-90), which are delivered directly to the liver tumor through the hepatic artery catheter In, the beta rays are accurately released, and the healthy liver tissue will get blood through the portal vein, so the damage to the surrounding healthy tissue can be minimized during the treatment.


The approval is based on the results of a clinical study called LEGACY, which aims to evaluate the safety and effectiveness of yttrium-90 microsphere therapy in the treatment of early and advanced hepatocellular carcinoma. The study analyzed the data of 162 patients and reached the objective remission rate and sustained remission time two primary endpoints (72.2% at 4 weeks and 76.1% at 6 months, respectively).


After two treatments, the patient had a complete or partial remission-all lesions disappeared or the diameter of the target lesion was reduced by 30%. The three-year overall survival rate of patients receiving transplantation or surgery was 93%.


The study found that patients with liver cancer showed a very high response rate and their survival time was significantly prolonged. It is recommended as the standard therapy for liver cancer patients. The results of the study have been published in the journal “Hepatology”, which can provide clinicians with a basis for decision-making.


The treatment with TheraSphere yttrium-90 therapy can be carried out without hospitalization and can be carried out in an outpatient clinic, which can be completed within one hour, which can relieve the pressure on medical resources, especially in the shadow of the epidemic.

The new guidelines issued by the National Institute of Health and Medical Excellence (NICE) recognize the benefits of SIRT for patients and hospitals.

The guidelines recommend that TheraSphere yttrium-90 therapy for hepatocellular carcinoma be included in the British National Health Service (NHS).


The benefits of yttrium-90 therapy in improving the survival rate and quality of life of patients with hepatocellular carcinoma have been proven by 20-year clinical trials and real-world research data from more than 70,000 patients worldwide.

The approval of the FDA in the United States and the recommendations of NICE in the United Kingdom are expected to further promote the popularization of this therapy.


It is reported that the researchers plan to start a clinical trial to study the therapeutic effect of TheraSphere yttrium-90 therapy + immunotherapy combination therapy in patients with hepatocellular carcinoma who are not eligible for treatment. In addition, related research will be carried out in other cancers (including prostate cancer and brain cancer).




▌Yttrium-90 therapy is not an “artifact”

It is understood that there are currently two yttrium-90 microsphere therapies in the world that have been clinically applied: TheraSphere (glass microspheres) and SirSphere (resin microspheres). Among them, the latter was approved by the FDA in 2002 for colorectal cancer and has already submitted a domestic marketing application.


Dr. Castro reminded that the yttrium-90 microsphere therapy should not be deified. It is necessary to fully consider its indications, evaluate the liver function and physical condition of the patient, and be vigilant and cope with complications.


In view of the complexity of liver cancer, the multidisciplinary assisted diagnosis and treatment model (MDT) is essential.

Patients with advanced liver cancer should ask a team of multidisciplinary experts to jointly formulate the most suitable personalized comprehensive diagnosis and treatment plan before trying new therapies.




▌What are the new developments in the treatment of liver cancer?

Yttrium-90 microsphere therapy is a local treatment. There have been many new developments in the systemic treatment of liver cancer in recent years, especially in targeted therapy and immunotherapy. The new therapies have prolonged survival and improved the quality of life for many patients.


◆ Targeted therapy for liver cancer:

◎ First-line targeted drugs

In 2005, the anti-angiogenic drug sorafenib was approved by the FDA for marketing and was the first liver cancer targeted drug.

In August 2018, the FDA approved lenvatinib for the first-line treatment of unresectable hepatocellular carcinoma.  In the new version of the “Medical Insurance Drug Catalog” in 2020, the price of lenvatinib medical insurance has been reduced by as much as 80.7%.


◎ Second-line targeted drugs

In 2017, Regorafenib was approved by the FDA for use in patients with advanced hepatocellular carcinoma who are resistant to sorafenib. At present, the drug has entered some countries’s medical insurance, with a drop rate of 45.56%.

In 2018, the FDA approved the listing of cabozantinib for the treatment of patients with advanced hepatocellular carcinoma who had progressed after receiving sorafenib or other standard systemic treatments.

In May 2019, ramucirumab was approved by the FDA as a second-line monotherapy for patients with liver cancer with alpha-fetoprotein (AFP) ≥400ng/ML and resistance to sorafenib.


◆ Liver cancer immunotherapy:

◎ Single-agent immunotherapy

In 2017, the FDA approved the “O drug” nivolumab for the market for liver cancer patients who had previously been treated with sorafenib (second-line treatment). This is the first immune checkpoint inhibitor approved for the treatment of liver cancer. This has overcome the long-standing limitations of liver cancer treatment.

In 2018, the “K drug” pembrolizumab was approved for a new indication for hepatocellular carcinoma patients who had previously been treated with sorafenib (second-line treatment).

In March 2020, the PD-1 inhibitor carrelizumab was approved by the National Food and Drug Administration for the treatment of patients with advanced hepatocellular carcinoma who have received sorafenib and/or oxaliplatin-containing system chemotherapy. This is China’s first approved liver cancer immunotherapy drug. The drug has now been included in medical insurance, and the price has been reduced by 80%.


◎ Combined immunotherapy

In March 2020, the FDA approved the combination of nivolumab and CTLA-4 inhibitor ipilimumab (O+Y) for the treatment of hepatocellular carcinoma patients who have previously received sorafenib therapy. This is the first dual immunotherapy approved by the FDA.


In May 2020, the FDA approved the anti-PD-L1 therapy “T drug” atelizumab combined with bevacizumab (T+A) as the first-line treatment for patients with unresectable hepatocellular carcinoma. This combination therapy is the first immunotherapy program approved for the treatment of unresectable liver cancer. It has been approved in China and has become the first choice for inoperable hepatocellular carcinoma patients with better liver function.


In addition, new therapies such as “D+T” dual immunotherapy, pembrolizumab + lenvatinib, and a new generation of immuno-immunotherapy M7824 have also been preliminarily verified in clinical trials. It is expected that these drugs can further improve liver cancer patients. Lifetime.


Unfortunately, some new therapies are only suitable for a small number of patients, and some have not yet been marketed in China. Before trying new therapies, you might as well invite authoritative experts at home and abroad to conduct remote consultations to evaluate the applicability of the new therapies.


In addition, for some patients whose treatment effect is not good, they may wish to consider participating in clinical trials of international cutting-edge new therapies, which is expected to benefit from the global cutting-edge medical results.






FDA approved TheraSphere yttrium-90 microsphere therapy for liver cancer

(source:internet, reference only)

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