【美国FDA新药快讯】
FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor
FDA also approves drug for second indication in a type of lung cancer
On August 15,2019, the U.S. Food and Drug Administration granted accelerated approval to Rozlytrek (entrectinib,CAS Registry Number 1108743-60-7), a treatment for adult and adolescent patients whose cancers have the specific genetic defect, NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments.
This is the third time the FDA has approved a cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated. The approval marks a new paradigm in the development of cancer drugs that are “tissue agnostic.” It follows the policies that the FDA developed in a guidance document released in 2018. The previous tissue agnostic indications approved by the FDA were pembrolizumab for tumors with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors in 2017 and larotrectinib for NTRK gene fusion tumors in 2018.
Rozlytrek was also approved today for the treatment of adults with non-small cell lung cancer whose tumors are ROS1-positive (mutation of the ROS1 gene) and has spread to other parts of the body (metastatic). Clinical studies evaluated 51 adults with ROS1-positive lung cancer. The overall response rate was 78%, with 5.9% of patients having complete disappearance of their cancer. Among the 40 patients with tumor shrinkage, 55% had tumor shrinkage persist for 12 months or longer.
Rozlytrek’s common side effects are fatigue, constipation, dysgeusia (distorted sense of taste), edema (swelling), dizziness, diarrhea, nausea, dysesthesia (distorted sense of touch), dyspnea (shortness of breath), myalgia (painful or aching muscles), cognitive impairment (confusion, problems with memory or attention, difficulty speaking, or hallucinations), weight gain, cough, vomiting, fever, arthralgia and vision disorders (blurred vision, sensitivity to light, double vision, worsening of vision, cataracts, or floaters). The most serious side effects of Rozlytrek are congestive heart failure (weakening or damage to the heart muscle), central nervous system effects (cognitive impairment, anxiety, depression including suicidal thinking, dizziness or loss of balance, and change in sleep pattern, including insomnia and excessive sleepiness), skeletal fractures, hepatotoxicity (damage to the liver), hyperuricemia (elevated uric acid), QT prolongation (abnormal heart rhythm) and vision disorders. Health care professionals should inform females of reproductive age and males with a female partner of reproductive potential to use effective contraception during treatment with Rozlytrek. Women who are pregnant or breastfeeding should not take Rozlytrek because it may cause harm to a developing fetus or newborn baby.
Rozlytrek was granted accelerated approval. This approval commits the sponsor to provide additional data to the FDA. Rozlytrek also received Priority Review, Breakthrough Therapy and Orphan Drug designation. The approval of Rozlytrek was granted to Genentech, Inc.
Link: https://t.cn/AiESKAHp
FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor
FDA also approves drug for second indication in a type of lung cancer
On August 15,2019, the U.S. Food and Drug Administration granted accelerated approval to Rozlytrek (entrectinib,CAS Registry Number 1108743-60-7), a treatment for adult and adolescent patients whose cancers have the specific genetic defect, NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments.
This is the third time the FDA has approved a cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated. The approval marks a new paradigm in the development of cancer drugs that are “tissue agnostic.” It follows the policies that the FDA developed in a guidance document released in 2018. The previous tissue agnostic indications approved by the FDA were pembrolizumab for tumors with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors in 2017 and larotrectinib for NTRK gene fusion tumors in 2018.
Rozlytrek was also approved today for the treatment of adults with non-small cell lung cancer whose tumors are ROS1-positive (mutation of the ROS1 gene) and has spread to other parts of the body (metastatic). Clinical studies evaluated 51 adults with ROS1-positive lung cancer. The overall response rate was 78%, with 5.9% of patients having complete disappearance of their cancer. Among the 40 patients with tumor shrinkage, 55% had tumor shrinkage persist for 12 months or longer.
Rozlytrek’s common side effects are fatigue, constipation, dysgeusia (distorted sense of taste), edema (swelling), dizziness, diarrhea, nausea, dysesthesia (distorted sense of touch), dyspnea (shortness of breath), myalgia (painful or aching muscles), cognitive impairment (confusion, problems with memory or attention, difficulty speaking, or hallucinations), weight gain, cough, vomiting, fever, arthralgia and vision disorders (blurred vision, sensitivity to light, double vision, worsening of vision, cataracts, or floaters). The most serious side effects of Rozlytrek are congestive heart failure (weakening or damage to the heart muscle), central nervous system effects (cognitive impairment, anxiety, depression including suicidal thinking, dizziness or loss of balance, and change in sleep pattern, including insomnia and excessive sleepiness), skeletal fractures, hepatotoxicity (damage to the liver), hyperuricemia (elevated uric acid), QT prolongation (abnormal heart rhythm) and vision disorders. Health care professionals should inform females of reproductive age and males with a female partner of reproductive potential to use effective contraception during treatment with Rozlytrek. Women who are pregnant or breastfeeding should not take Rozlytrek because it may cause harm to a developing fetus or newborn baby.
Rozlytrek was granted accelerated approval. This approval commits the sponsor to provide additional data to the FDA. Rozlytrek also received Priority Review, Breakthrough Therapy and Orphan Drug designation. The approval of Rozlytrek was granted to Genentech, Inc.
Link: https://t.cn/AiESKAHp
Shams：湖人已经向联盟申请175万美元的伤病特例
由于湖人中锋德马库斯-考辛斯预计会因左膝前交叉韧带撕裂而赛季报销，因此湖人已经向联盟申请了175万美元的伤病特例。
根据薪资专家Bobby Marks的报道，因为考辛斯下赛季的薪水仅为350万美元，所以湖人所能申请到的伤病特例为175万美元。在湖人提出申请后，联盟将会判定考辛斯能否在2020年6月15日前复出。
若得到175万美元的伤病特例，湖人可以选择签下一名自由球员、或交易来一名合同只剩最后一年的球员、或认领一名合同只剩最后一年的被裁球员，但都不能超过伤病特例的金额。
#世界杯稳不稳# #篮球世界杯# #NBA吐槽大会#
由于湖人中锋德马库斯-考辛斯预计会因左膝前交叉韧带撕裂而赛季报销，因此湖人已经向联盟申请了175万美元的伤病特例。
根据薪资专家Bobby Marks的报道，因为考辛斯下赛季的薪水仅为350万美元，所以湖人所能申请到的伤病特例为175万美元。在湖人提出申请后，联盟将会判定考辛斯能否在2020年6月15日前复出。
若得到175万美元的伤病特例，湖人可以选择签下一名自由球员、或交易来一名合同只剩最后一年的球员、或认领一名合同只剩最后一年的被裁球员，但都不能超过伤病特例的金额。
#世界杯稳不稳# #篮球世界杯# #NBA吐槽大会#
#2019法兰克福车展# 大众正式发布了全新的品牌Logo，增加了更多的扁平化的设计元素。取代了2000年首次推出的三维蓝色和银色标志。正如大众董事会成员品牌销售负责人JürgenStackmann在发布会现场说道“The new brand design marks the start of the new era for Volkswagen（新的品牌设计，标志着大众全新的开始）”。
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