the 3rd sNDA for Toripalimab in China
SHANGHAI, China, Feb. 19, 2021 (GLOBE NEWSWIRE) Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that the National Medical Products Administration (NMPA) of China has accepted its supplemental New Drug Application (sNDA) for Toripalimab combined with chemotherapy for the first-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma.
The supplemental NDA is based on the JUPITER-02 study (NCT03581786), which is a randomized, double-blind, placebo-controlled Phase III study led by Professor Ruihua Xu from Sun Yat-sen University Cancer Center. The results of the study showed that Toripalimab combined with gemcitabine/cisplatin as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma significantly prolonged the progression-free survival a
P=0.03).
Subgroup analyses showed that sequential CRT improved DFS outcomes in high-risk women compared with radiation alone (HR 0.48, 95% CI 0.26-0.88), as well as in the intermediate-risk group (HR 0.56, 95% CI 0.34-0.91).
Sequential CRT should be considered a preferred adjuvant treatment after radical hysterectomy for patients with early-stage cervical cancer, Liu and co-authors concluded.
Concurrent CRT, on the other hand, failed to significantly improve DFS or OS compared with radiation alone.
In an accompanying editorial, Bradley Monk, MD, of the University of Arizona College of Medicine in Phoenix, and colleagues called the findings provocative and promising, but also pointed to various limitations. For one, patients assigned to concurrent CRT did not tolerate it well, which is not consistent with U.S. experience and underpowers this arm for reliable comparison, the editorialists wrote.
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IMAGE: Example of one CT image and the corresponding output from the deep learning model view more
Credit: SIAT
Stomach cancer, or gastric cancer, is a common gastrointestinal malignancy. Peritoneal metastasis occurs in a majority of patients with advanced stomach cancer and is considered as an aggressive disease with poor outcomes.
Patients with peritoneal metastasis are typically not eligible for curative surgery. Therefore, preoperative detection and diagnosis of peritoneal metastasis are critical to inform treatment decision-making and avoid unnecessary surgery.
A new study published in the
JAMA Network Open on Jan. 5 shows that deep learning can help predicting the occult peritoneal metastasis in stomach cancer. It provides a novel and noninvasive approach for stomach cancer patients and may inform individualized surgical management of stomach cancer.
Researchers develop deep learning model to predict occult peritoneal metastasis in gastric cancer patients
Stomach cancer, or gastric cancer, is a common gastrointestinal malignancy. Peritoneal metastasis occurs in a majority of patients with advanced stomach cancer and is considered as an aggressive disease with poor outcomes.
Patients with peritoneal metastasis are typically not eligible for curative surgery. Therefore, preoperative detection and diagnosis of peritoneal metastasis are critical to inform treatment decision-making and avoid unnecessary surgery.
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A new study published in the
JAMA Network Open on Jan. 5 shows that deep learning can help predicting the occult peritoneal metastasis in stomach cancer. It provides a novel and noninvasive approach for stomach cancer patients and may inform individualized surgical management of stomach cancer.
Source: Xinhua|
Editor: huaxia
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HANGZHOU, Dec. 17 (Xinhua) Ensartinib hydrochloride, a targeted drug for lung cancer developed by a Chinese firm, has been available in hospitals and pharmacies nationwide since Wednesday, according to its developer Beta Pharma.
The Guangzhou-based Sun Yat-sen University Cancer Center prescribed the medication on Wednesday, first in China.
Lung cancer is China s leading cause of mortality and morbidity in malignant tumor diseases, among which about 80 to 85 percent are non-small cell lung cancers (NSCLCs). Anaplastic Lymphoma Kinase (ALK), one of the major carcinogenic drivers of NSCLCs, may be activated by genetic lesions in a certain percentage of patients with NSCLCs.