{"id":26695,"date":"2025-07-08T10:18:36","date_gmt":"2025-07-08T03:18:36","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=26695"},"modified":"2025-07-08T10:18:36","modified_gmt":"2025-07-08T03:18:36","slug":"sirtex-medicals-sir-spheres-y-90-resin-microspheres-receive-fda-approval-for-the-treatment-of-unresectable-hepatocellular-carcinoma","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=26695","title":{"rendered":"Sirtex Medical’s SIR-Spheres\u00ae Y-90 Resin Microspheres Receive FDA Approval for the Treatment of Unresectable Hepatocellular Carcinoma"},"content":{"rendered":"\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Expanded indication makes <\/i>SIR-Spheres\u00ae <\/sup><\/i>the first and only radioembolization therapy in the U.S. approved to treat both unresectable hepatocellular carcinoma and metastatic colorectal cancer<\/i><\/p>\n

WOBURN, Mass.<\/span><\/span>, July 7, 2025<\/span><\/span> \/PRNewswire\/ —\u00a0Sirtex Medical (“Sirtex”)<\/a>, a leading manufacturer of interventional oncology solutions, today announced that the U.S. Food and Drug Administration (FDA) approved SIR-Spheres\u00ae<\/sup> Y-90<\/span> resin microspheres for the treatment of unresectable hepatocellular carcinoma (HCC) in the United States<\/span>. With this approval, SIR-Spheres\u00ae<\/sup>\u00a0is the only radioembolization therapy approved for the treatment of both metastatic colorectal cancer (mCRC) of the liver and HCC in the U.S.<\/p>\n

HCC is the most common form of liver cancer in adults in the U.S., according to the American Cancer Society<\/a>. Radioembolization\u2013commonly referred to as selective internal radiation therapy (SIRT)\u2013with SIR-Spheres\u00ae<\/sup> uses personalized dosimetry to deliver the optimal dose of radiation directly to tumors in patients with HCC. This approval gives clinicians expanded flexibility in selecting a liver-directed therapy that aligns with patient-specific needs and treatment goals.<\/p>\n

“The expanded indication makes SIR-Spheres\u00ae<\/sup> the only Y-90<\/span> treatment approved in the U.S. for both HCC and mCRC,” said Matt Schmidt<\/span>, CEO of Sirtex. “This milestone reflects our ongoing commitment to delivering flexible, personalized therapies\u2014with multiple dose options available daily\u2014that empowers physicians to treat patients when and where it works best.”<\/p>\n

This regulatory milestone is supported by results from the DOORwaY90<\/sup> study, a prospective, multicenter, open-label clinical trial evaluating the safety and efficacy of SIR-Spheres\u00ae<\/sup> in treating HCC. The study enrolled 100 patients across 18 U.S. centers, with 65 patients included in the interim primary efficacy cohort. DOORwaY90<\/sup> met its prespecified co-primary endpoints, demonstrating a best overall response rate (ORR) of 98.5% as assessed by independent central review. All evaluable patients demonstrated a response, indicating a 100% local tumor control rate. Additionally, the median duration of response (DoR) exceeded 300 days. These findings highlight SIR-Spheres\u00ae<\/sup> as a highly effective liver-directed therapy with a favorable safety profile.<\/p>\n

“This study moves the field of radioembolization forward with reproducible dosimetry outcomes and a strong safety profile linked to very positive clinical results,” said Dr. Armeen Mahvash<\/span>, Interventional Radiologist at MD Anderson Cancer Center and Co-Principal Investigator of the DOORwaY90<\/sup> Study. “This will give multidisciplinary care teams the confidence to recommend SIR-Spheres\u00ae<\/sup> for HCC treatment.”<\/p>\n

For more information and details on how to incorporate SIR-Spheres\u00ae<\/sup> into your practice, please contact Sirtex at\u00a0info-use@sirtex.com<\/b><\/a>.<\/p>\n

About SIR-Spheres<\/b>\u00ae<\/sup>
<\/b>SIR-Spheres\u00ae<\/sup> Y-90<\/span> resin microspheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with no macrovascular invasion, Child-Pugh A cirrhosis, well-compensated liver function, and good performance status. They are also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine).<\/p>\n

Caution: Federal (USA<\/span>) law restricts this device for sale by or on the order of a physician. Consult the Instructions for Use (<\/b>www.sirtex.com\/sir-spheres\/risks_adverse-events<\/b><\/a>) for a complete listing of indications, contraindications, side effects, warnings and precautions.<\/b><\/p>\n

About Sirtex
<\/b>Sirtex Medical is a global healthcare company focused on advancing minimally invasive, liver-directed cancer and embolization therapies. With offices in the U.S., Australia<\/span>, Europe<\/span>, and Asia<\/span>, Sirtex delivers innovative interventional oncology and embolization solutions to physicians and patients worldwide. The company’s lead product, SIR-Spheres\u00ae<\/sup> Y-90<\/span> resin microspheres, is now the only FDA approved product in the United States<\/span> indicated for both the treatment of hepatocellular carcinoma (HCC) and metastatic colorectal cancer (mCRC). For more information, visit www.sirtex.com<\/a>.<\/p>\n

APM-US-010-06-25<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Expanded indication makes <\/i>SIR-Spheres\u00ae <\/sup><\/i>the first and only radioembolization therapy in the U.S. approved to treat both unresectable hepatocellular carcinoma and metastatic colorectal cancer<\/i><\/p>\n

WOBURN, Mass.<\/span><\/span>, July 7, 2025<\/span><\/span> \/PRNewswire\/ —\u00a0Sirtex Medical (“Sirtex”)<\/a>, a leading manufacturer of interventional oncology solutions, today announced that the U.S. Food and Drug Administration (FDA) approved SIR-Spheres\u00ae<\/sup> Y-90<\/span> resin microspheres for the treatment of unresectable hepatocellular carcinoma (HCC) in the United States<\/span>. With this approval, SIR-Spheres\u00ae<\/sup>\u00a0is the only radioembolization therapy approved for the treatment of both metastatic colorectal cancer (mCRC) of the liver and HCC in the U.S.<\/p>\n

HCC is the most common form of liver cancer in adults in the U.S., according to the American Cancer Society<\/a>. Radioembolization\u2013commonly referred to as selective internal radiation therapy (SIRT)\u2013with SIR-Spheres\u00ae<\/sup> uses personalized dosimetry to deliver the optimal dose of radiation directly to tumors in patients with HCC. This approval gives clinicians expanded flexibility in selecting a liver-directed therapy that aligns with patient-specific needs and treatment goals.<\/p>\n

“The expanded indication makes SIR-Spheres\u00ae<\/sup> the only Y-90<\/span> treatment approved in the U.S. for both HCC and mCRC,” said Matt Schmidt<\/span>, CEO of Sirtex. “This milestone reflects our ongoing commitment to delivering flexible, personalized therapies\u2014with multiple dose options available daily\u2014that empowers physicians to treat patients when and where it works best.”<\/p>\n

This regulatory milestone is supported by results from the DOORwaY90<\/sup> study, a prospective, multicenter, open-label clinical trial evaluating the safety and efficacy of SIR-Spheres\u00ae<\/sup> in treating HCC. The study enrolled 100 patients across 18 U.S. centers, with 65 patients included in the interim primary efficacy cohort. DOORwaY90<\/sup> met its prespecified co-primary endpoints, demonstrating a best overall response rate (ORR) of 98.5% as assessed by independent central review. All evaluable patients demonstrated a response, indicating a 100% local tumor control rate. Additionally, the median duration of response (DoR) exceeded 300 days. These findings highlight SIR-Spheres\u00ae<\/sup> as a highly effective liver-directed therapy with a favorable safety profile.<\/p>\n

“This study moves the field of radioembolization forward with reproducible dosimetry outcomes and a strong safety profile linked to very positive clinical results,” said Dr. Armeen Mahvash<\/span>, Interventional Radiologist at MD Anderson Cancer Center and Co-Principal Investigator of the DOORwaY90<\/sup> Study. “This will give multidisciplinary care teams the confidence to recommend SIR-Spheres\u00ae<\/sup> for HCC treatment.”<\/p>\n

For more information and details on how to incorporate SIR-Spheres\u00ae<\/sup> into your practice, please contact Sirtex at\u00a0info-use@sirtex.com<\/b><\/a>.<\/p>\n

About SIR-Spheres<\/b>\u00ae<\/sup>
<\/b>SIR-Spheres\u00ae<\/sup> Y-90<\/span> resin microspheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with no macrovascular invasion, Child-Pugh A cirrhosis, well-compensated liver function, and good performance status. They are also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine).<\/p>\n

Caution: Federal (USA<\/span>) law restricts this device for sale by or on the order of a physician. Consult the Instructions for Use (<\/b>www.sirtex.com\/sir-spheres\/risks_adverse-events<\/b><\/a>) for a complete listing of indications, contraindications, side effects, warnings and precautions.<\/b><\/p>\n

About Sirtex
<\/b>Sirtex Medical is a global healthcare company focused on advancing minimally invasive, liver-directed cancer and embolization therapies. With offices in the U.S., Australia<\/span>, Europe<\/span>, and Asia<\/span>, Sirtex delivers innovative interventional oncology and embolization solutions to physicians and patients worldwide. The company’s lead product, SIR-Spheres\u00ae<\/sup> Y-90<\/span> resin microspheres, is now the only FDA approved product in the United States<\/span> indicated for both the treatment of hepatocellular carcinoma (HCC) and metastatic colorectal cancer (mCRC). For more information, visit www.sirtex.com<\/a>.<\/p>\n

APM-US-010-06-25<\/p>\n

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