Roche's innovative breast cancer target drug Patett ® another indication approved in China

　　Pharmaceutical Network December 13 - Roche Pharmaceuticals China recently announced that China's National Drug Administration (NMPA) has officially approved the Padette ® (Patojusmono) joint Heseltine ® (Quto-zhu mono-resistance) and dosita-combination for HER2-positive metastatic breast cancer patients who have not received anti-HER2 treatment or chemotherapy first-line standard treatment plan The approval of this program, to achieve the gradual internationalization of the treatment plan of her2-positive advanced breast cancer patients in China, will bring longer survival benefits to HER2-positive breast cancer patients, help to achieve the slow treatment of breast cancer diagnosis and treatment, so that advanced breast cancer out of the "terminal disease" is possible Patojus mono-resistance, quto-zhu mono-anti-double-target joint dositarace is the international treatment of HER2-positive advanced breast cancer standard first-line treatment Now Padet ® advanced breast cancer first-line indication synostication in China, not only for domestic patients is of great significance, will further promote the process of standardized diagnosis and treatment of advanced breast cancer in China breast cancer is the most common malignant in China's , ranking first in the incidence of malignant tumors in women Among them, HER2-positive breast cancer accounts for about 20%-30% of the patients' overall low quality of life due to their high degree of malignancy, rapid progression of the disease, the susceptibility to lymph node metastasis, short period of chemotherapy remission, and relative resistance to endocrine therapy and in China each year of new breast cancer cases, about 3% to 10% of women at the time of diagnosis has a distant metastasis In early patients, 30 to 40% will develop advanced breast cancer, the 5-year survival rate is only 20%, the overall median survival time is only 2 to 3 years The approval of Thetmet's ® advanced stage treatment of breast cancer will benefit her 2-positive patients with advanced breast cancer for longer this first-line treatment indication of® herher2-positive advanced breast cancer was approved mainly based on two studies of CLEOPATRA clinical studies that lasted up to 8 years follow-up and the PUFFIN study from the Chinese group CLEOPATRA studies show that patozumab and quto-bead mono-anti-combination dositarace can extend the progression-free survival (PFS) of HER2-positive patients with advanced breast cancer patients by 51%, to 18.7 months, to extend the total survival (OS) of patients by 40%, and to extend the survival period to nearly 5 years With the extension of the study follow-up time, in the median follow-up 8 years (up to 10 years), patozumab mono-anti-quto-zhu-mono-resistance combined dositarace treatment group 37% of patients reached eight years of survival, significantly higher than 23% of the quto-zhu mono-resistance group THE PUFFIN STUDY IS A BRIDGE STUDY OF CLEOPATRA, AND THE 243 CASES OF HER2-POSITIVE ADVANCED BREAST CANCER IN THE GROUP WERE ALL CHINESE PATIENTS, AND THEY WERE FOUND IN 15 CLINICAL CENTERS ACROSS THE COUNTRY The progressionless lifetime (PFS) benefit trends in the PUFFIN study are consistent with global data from CLEOPATRA to PUFFIN two clinical trials we can see that whether foreigners or Chinese, patozumab monoantigen and qutobeu-bead monoantigen combined with dositarace treatment thanthatothana treatment than the mono-target therapy can further prolong the progression-free survival (PFS) Professor Xu Binghe, of Oncology at the National Cancer Center and the Chinese Academy of Medical Sciences, who led the PUFFIN study, said: "The PUFFIN study demonstrated a high degree of consistency in the efficacy of HER2-positive breast cancer patients in China and the INTERNATIONAL CLEOPATRA study It is confirmed that the patozumab-combination quto-bead mono-target program also has safety and survival benefits in Chinese patients, and provides strong evidence-based medical evidence for Chinese patients to use the Patozumab mono-combination quto-bead mono-target program more assuredly It is believed that with the longer follow-up time, we will also see the total survival (OS) in the PUFFIN study will show amazing data, further promoting the her2-positive breast cancer diagnosis and treatment pattern changes in China "
how can the two-target program of Patozhu single anti-joint quto-zhu single anti-double-target program effectively promote the slow-disease management of advanced breast cancer? Professor Jiang Zefei, Vice President of the Chinese Society of Clinical Oncology (CSCO), explained: "The CLEOPATRA study this year published an eight-year follow-up study, with an overall survival rate of nearly 40% over eight years In the field of breast cancer treatment, it is difficult to have such a long time to observe research, because after all, it is a terminal patient From the results of cleOPATRA studies, it is not difficult to see that the vast majority of patients can achieve long-term survival benefits after receiving the right double-target treatment "in addition to , The Padet ® (Patozumab) and Hercetin® (Quto-Zhumono) and chemotherapy can also benefit patients with HER2-positive advanced breast cancer in front-line treatment Its efficacy is not affected by the previous acceptance (new) auxiliary qutomonomono-resistance treatment, age, hormone receptor state, in the occurrence of brain metastasis, visceral metastasis, bone metastasis of her2 positive late patients can also maintain a significant benefit, to all advanced patients bring the dawn, so that advanced breast cancer out of the "terminal disease" possible For patients with advanced breast cancer, experts call edgtosis for early diagnosis and early detection to reduce the chance of first-stage breast cancer On the other hand, for patients who, for various reasons, may develop advanced, care should be taken to intervene as early as possible in accordance with the Guidelines to extend the life span and improve their quality of life the "
China 2030" outline issued by the CPC Central Committee and the State Council on July 15, 2019, mentioned that "by 2022 and 2030, the overall five-year survival rate for cancer will not be less than 43.3% and 46.6%, respectively." At present, the 5-year survival rate of early breast cancer patients in China can reach 83.2%, has achieved the transformation of "chronic diseases", but if you want to improve the overall survival rate of breast cancer, the survival rate of breast cancer patients only 20% of the current short board is particularly critical Therefore, the approval of the first-line advanced therapeutic indications of toe totwot adouble also responds to this demand, which will help to improve the survival rate of patients with advanced breast cancer in China and add to the construction of healthy China  Zhou Hong, president of Roche Pharmaceuticals China, said: "The time of the Pattet ® (Patozhu mono-resistance) to enter China is later than the European and American markets, but in a year all three indications were approved in China, with the European and American to achieve synchronization, this world-class approval speed, showing the Chinese government through reform to accelerate the introduction of innovative drugs, and continuously improve the health of theChinese people's determination Roche will continue to uphold the concept of 'patient first needs' and, on the basis of innovation and research, bring more innovative products to the market, benefiting more breast cancer patients in China "
December 2018, The first indication synome of the ® was approved in China for complementary treatment for HER2-positive early breast cancer patients with high recurrence risk of combination of quto-bead and chemotherapy, significantly reducing the risk of recurrence in HER2-positive early breast cancer patients with a high risk of recurrence, marking the official entry of Anti-HER2 treatment in China into the two-target era In August 2019, China's State administration of and Supervision approved patozumab-combination quto-bead monoboland and chemotherapy for new complementary treatments for HER2-positive patients with late-local, inflammatory or early stage breast cancer (diameter 2cm or lymph node-positive) as part of an overall treatment plan for her2 early breast cancer Now, The first-line treatment of her2-positive advanced breast cancer in the ® is now the third approved indication in China The combination chemotherapy treatment of Patozumab mono-anti-and quto-zhu-mono-anti-combination has been constructed for patients from the starting new auxiliary stage to the auxiliary stage after surgery, and even the whole process of advanced treatment of HER2 inhibition management, and has a positive significance for the standardized diagnosis and treatment of breast cancer in China recent health insurance negotiations have been settled, the two-target treatment program of Theetin ® successfully renewed through the National Health Insurance Negotiations, and the addition of new complementary treatment indications, while the Padet ® for HER2-positive local ized, inflammatory or early breast cancer patients and for patients with high recurrence risk OF HER2 positive early breast cancer treatment is also included in the National Basic Medical Insurance, Injury Insurance and Maternity Insurance Drug Catalog for the first time It is believed that under the umbrella of the national health insurance policy, the accessibility of patients' medication will be greatly improved, and more and more breast cancer patients will be able to receive and benefit from the standardized two-target treatment 　　Swain SM, Baelga J, Kim SB, et al Pertuzumab, tratuzumba, and docetaxel in HER2-poitive metatatic breat cancer N Engl J Med, 2015, 372 (8): 724-734.
Consensus on Clinical Treatment of Advanced Breast Cancer in China (2018), China Journal of Oncology September 2018 Volume 40, Issue 9 　　Swain SM, et al ASCO.2019 abtract 1020
s Binghe Xu, et al 2019 ASCO Abtract 1026 In Vivo 2018 Jul-Aug; 32 (4): 839-842.
Binghe Xu, et al 2019 ASCO Abtract 1026