Bayer Dofigo ® approved in China: new alpha particle-targeted drugs for prostate cancer treatment.

Introduction: Bayer Dofigo ® approved for the treatment of patients with despotic resistant prostate cancer (CRPC) with symptomatic bone metastasis and no known visceral metastasis.
beijing, August 27, 2020 /XINHUA/ -- Bayer corporation today announced that Dofigo ® (Chlorinated Xenon (223Ra) injection) has been approved by the State Drug Administration for the treatment of patients with despotic resistant prostate cancer (CRPC) with symptomatic bone metastasis and no known visceral metastasis.
Dofigo® is a radiation-active therapy that emits alpha particles, and the Critical Phase III ALSYMPCA study has shown that Dofigo® survives significantly compared to placebos, has good safety, and improves the quality of life (QoL) of patients, providing triple benefits to prostate cancer patients.
" nearly a decade, with the aging of the population, the incidence of prostate cancer in China is rising rapidly.
metastatic desopathic prostate cancer (mCRPC) is a cancer that has spread beyond the prostate and is resistant to both drug desopathy and surgical desopathy.
Professor Ye Dingwei, Chairman of the Professional Committee of the Department of Urology and Male Reproduction of the Chinese Anti-Cancer Association, said, "About 90% of men with mCRPC have radiological evidence of bone metastasis, and bone metastasis may lead to an increase in the frequency of bone events, and has been shown to be the main cause of morbidity and death in CRPC patients."
, early diagnosis and treatment of bone metastasis are critical for CRPC patients.
Dofigo® is a radiation-active therapy that emits alpha particles, the active part of which simulates calcium ions and is pro-bone, especially in areas where bone metastasis pathogenic bone hyperpluration is active by forming a complex with hydroxyphosphate (HAP) in the bone.
particles emitted by radon-223 can cause high-frequency double-stranded DNA fractures in adjacent tumor cells, resulting in a powerful cytotoxic effect.
, the alpha particle emission radius is less than 100 microns (less than 10 cell diameters) to minimize damage to the surrounding normal tissue.
approval of the ® is based on data from key Phase III ALSYMPCA studies and Phase III studies conducted in Asia 15397.
the study, Dofigo® significantly improved total lifetime (OS) compared to placebo, while delaying the on-the-first symptomatic bone event (SSE).
the risk of adverse events in the treatment group was similar to or even lower in the placebo group, suggesting that ® had good safety.
, the quality of life (QoL) of patients in the treatment group was significantly improved.
"Dofigo® has improved the effectiveness and safety of treatment for prostate cancer patients in a whole new way," said David Jiang, Global Executive Vice President and President of Bayer Group's Prescription Medicines Division in China and Asia Pacific.
with the approval of Dofigo® Bayer's Oncology business unit will open up a new field of treatment for prostate cancer in China, providing treatment options for Chinese prostate cancer patients at different stages of the disease.
is committed to meeting the treatment needs of patients in China with innovative drugs, and this is another example of our commitment.
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