Anlotinib's fifth indication - iodine-refractory differentiated thyroid cancer officially approved

China's National Medical Products Administration (NMPA) officially approved Chia Tai Tianqing's Class 1 new drug for the treatment of patients with progressive, locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC)
.
As the first domestic original multi-target tyrosine kinase inhibitor (TKI) approved for RAIR-DTC indications in China, Anlotinib has been rapidly approved in five fields including lung cancer, soft tissue sarcoma, and thyroid cancer in just 4 years.
Indications
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The approval of the new indication of RAIR-DTC will fill the gap in this therapeutic field in China, provide a new choice for Chinese patients, and demonstrate the "hard core strength" of Anlotinib
.
Complementing the "shortcomings" of RAIR-DTC drug selection, Anlotinib is "coming from the waves" According to the latest statistics from the World Health Organization (WHO), there will be more than 220,000 new cases of thyroid cancer in China in 2020
.
DTC is the most common type, accounting for more than 95% of all thyroid cancers, and consists of papillary, follicular, and Hürthle cell carcinomas
.
Most DTC patients have a good prognosis after standardized treatment, but about 23% of patients still develop distant metastasis
.
About 1/3 of patients with distant metastases have degenerative changes in tumor cell morphology and function during their natural course or treatment process, and lose the ability to concentrate iodine, and eventually develop iodine-refractory DTC (RAIR-DTC, radioiodine refractory).
differentiated thyroid cancer)
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The survival time of RAIR-DTC patients is significantly shorter than that of DTC patients with good iodine intake.
The average survival time is only 3-5 years, and the 10-year survival rate is about 10%
.
At the same time, Chinese RAIR-DTC patients are still facing the dilemma of a long-term lack of effective drugs, which are far from meeting clinical needs.

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The key clinical study approved for this indication is a multi-center, randomized controlled, phase II clinical trial of anlotinib in the treatment of locally advanced or metastatic RAIR-DTC.
The results of the study showed that the median PFS in the anlotinib group At 40.
54 months, compared with 8.
38 months in the placebo group (HR=0.
21; p<0.
0001), the risk of disease progression was significantly reduced by 79%, and preliminary data showed a 43% reduction in the risk of death (HR=0.
57, p=0.
0976)
.
It is precisely because of the tangible clinical benefits brought to patients that Anlotinib has received strong support from the State Drug Administration and many Chinese clinical experts in both clinical trials and new drug approval processes
.
In terms of short-term efficacy, ORR was 59.
2% in the anlotinib group and 0% in the placebo group (p<0.
0001); DCR in the anlotinib group was 97.
4% and 78.
4% in the placebo group (p=0.
0019).
It means that Anlotinib can effectively reduce the tumor burden of patients
.
In terms of safety, the incidence of serious adverse reactions (SAE) related to anlotinib treatment was 15.
8%, which was not significantly different from the placebo group (8.
1%, p=0.
3781)
.
And anlotinib was well tolerated, with only 34.
2% of patients taking anlotinib requiring dose adjustment
.
Breakthrough, Anlotinib Brings a New Choice for Chinese RAIR-DTC Patients ” recommends anlotinib for the systemic treatment of recurrent/metastatic RAIR-DTC
.
The guidelines also pointed out: Anlotinib does not seem to be inferior to overseas original targeted drugs in terms of efficacy and safety.

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Professor Gao Ming, the principal investigator of the registered clinical study and president of Tianjin People's Hospital, said: "Anlotinib is the first domestic original multi-target tyrosine kinase inhibitor (TKI) approved for RAIR-DTC indications.
), the approval of this new indication is undoubtedly a 'professional gospel' for the majority of patients, and has revolutionized the treatment pattern of recurrent/metastatic RAIR-DTC, adding a 'sharp edge' for clinicians
.
At the same time, anlotinib As a domestic original research drug, it has greatly improved the availability of drugs, and can effectively defend the "last mile" of patients' medication, bringing practical benefits to more patients
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The excellent performance in multiple cancer types in the past means that Anlotinib has great promise, and we also look forward to the broader application prospects of Anlotinib!" Mr.
Yu Kangxin, President of Chia Tai Tianqing Pharmaceutical Group, said: "We are very pleased to see the fifth indication of Anlotinib- - The indication of iodine-refractory differentiated thyroid cancer was officially approved, bringing good news to these patients
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In the future, we will continue to explore the application value of Anlotinib in more tumor types, and continue to provide the majority of tumor patients with A treatment plan with better efficacy and safety will inject lasting new vitality into the development of the industry
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As a pioneer of local pharmaceutical companies, Chia Tai Tianqing Pharmaceutical will continue to adhere to the concept of 'health technology? The unmet clinical needs of patients will promote the development of cancer prevention and treatment in China, and contribute to the realization of the strategic goal of 'Healthy China 2030'!" The enthusiasm for more cross-disease research on anlotinib in China's clinical field has not diminished, and it has achieved success Including five indications of non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), soft tissue sarcoma, medullary thyroid cancer, and differentiated thyroid cancer
.
At present, the role and contribution of national innovative drugs in the field of cancer are becoming more and more prominent.
In the future, Chinese cancer patients will be expected to have more individualized treatment options in the treatment of tumor diseases, just like patients in developed countries.
The future is promising
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