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Click on the translational medicine website above to subscribe to our dry goods | Reliable | Practical May 28, 2021, FDA announced accelerated approval of KRAS inhibitor Lumakras (active ingredient sotorasib, AMG510) for the treatment of non-small cell lung cancer with KRAS-G12C mutation (NSCLC) patients, this is the first anti-cancer therapy targeting specific KRAS gene mutations.
KRAS gene mutation is one of the most common oncogene mutations in cancer patients, and it is also a well-known "non-drug" target.
KRAS-G12C mutation refers to the mutation of the 12th amino acid of the KRAS protein sequence from normal glycine (code-named G) to cysteine (code-named C).
Lung cancer ranks among the top three in morbidity and cancer mortality worldwide, of which NSCLC accounts for about 80%.
KRAS-G12C is one of the most common driver mutations in NSCLC, accounting for 13%.
At the beginning of December 2020, the US FDA granted sotorasib Breakthrough Drug Qualification (BTD) and Real-time Oncology Review Qualification (RTOR).
At the end of January 2021, sotorasib was granted the Breakthrough Therapy Drug qualification by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.
Now, the FDA's approval of Lumakras is based on the results of a subgroup of patients in the CodeBreaK 100 clinical trial.
This subgroup includes 124 patients with KRAS-G12C mutation-positive NSCLC who have undergone immunotherapy and/or chemotherapy after disease progression.
The results of the trial showed that the overall response rate of patients treated with Lumakras at a dose of 960 mg was 36% (95% CI: 28-45), the disease control rate reached 81% (95% CI: 73-87), and the median response continued The time is 10 months.
The most common adverse reactions are diarrhea, musculoskeletal pain, nausea, fatigue, liver toxicity and cough.
Nine percent of patients had adverse reactions that led to the permanent discontinuation of Lumakras.
Dr.
Richard Pazdur, Acting Director of the Office of Oncology and Diseases of the FDA's Center for Drug Evaluation and Research, said: "The approval of Lumakras marks an important step towards cancer treatment.
In the future, more cancer patients will be able to have personalized treatments.
"In general, Lumakras is the first KRAS-G12C inhibitor to enter the clinic, which also gives us renewed hope for the successful treatment of KRAS mutant cancers.
Reference material: https:// Recommended reading: [Nature Sub-Journal] Reactivate "paralyzed" immune cells | Innovative therapy for glioma is here! [Industry News] The second phase of Wuhan's new crown vaccine project was put into production, and the annual production capacity is expected to reach 1 billion doses.
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KRAS gene mutation is one of the most common oncogene mutations in cancer patients, and it is also a well-known "non-drug" target.
KRAS-G12C mutation refers to the mutation of the 12th amino acid of the KRAS protein sequence from normal glycine (code-named G) to cysteine (code-named C).
Lung cancer ranks among the top three in morbidity and cancer mortality worldwide, of which NSCLC accounts for about 80%.
KRAS-G12C is one of the most common driver mutations in NSCLC, accounting for 13%.
At the beginning of December 2020, the US FDA granted sotorasib Breakthrough Drug Qualification (BTD) and Real-time Oncology Review Qualification (RTOR).
At the end of January 2021, sotorasib was granted the Breakthrough Therapy Drug qualification by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.
Now, the FDA's approval of Lumakras is based on the results of a subgroup of patients in the CodeBreaK 100 clinical trial.
This subgroup includes 124 patients with KRAS-G12C mutation-positive NSCLC who have undergone immunotherapy and/or chemotherapy after disease progression.
The results of the trial showed that the overall response rate of patients treated with Lumakras at a dose of 960 mg was 36% (95% CI: 28-45), the disease control rate reached 81% (95% CI: 73-87), and the median response continued The time is 10 months.
The most common adverse reactions are diarrhea, musculoskeletal pain, nausea, fatigue, liver toxicity and cough.
Nine percent of patients had adverse reactions that led to the permanent discontinuation of Lumakras.
Dr.
Richard Pazdur, Acting Director of the Office of Oncology and Diseases of the FDA's Center for Drug Evaluation and Research, said: "The approval of Lumakras marks an important step towards cancer treatment.
In the future, more cancer patients will be able to have personalized treatments.
"In general, Lumakras is the first KRAS-G12C inhibitor to enter the clinic, which also gives us renewed hope for the successful treatment of KRAS mutant cancers.
Reference material: https:// Recommended reading: [Nature Sub-Journal] Reactivate "paralyzed" immune cells | Innovative therapy for glioma is here! [Industry News] The second phase of Wuhan's new crown vaccine project was put into production, and the annual production capacity is expected to reach 1 billion doses.
The anus can not only fart, but also breathe, which is expected to become a new treatment for respiratory failure! [News] Dawn of Type 1 Diabetes! FDA supports teplizumab treatment drug details
