A cancer target that was long thought to be “invasive” has finally been approved by the FDA-approved therapy: NCC-treated patients with advanced genetic mutations in patients with advanced cervical cancer.
The FDA decision Friday makes Amgen, a drug approved for KRAS mutations, sotorasbib. Mutation in KRAS is 25% of mutation in NSCLC. Sotherapeutic approval specifically covers the KRAS G12C subunit of these mutations, with the FDA accounting for about 13% of mutations in the NCSLC.
The FDA has approved the use of amoxicillin as a second-line treatment for patients who have previously received at least one systematic treatment. The KRAS G12C mutation was also detected by a health care partner Approved On Friday. Amgen is launching its new cancer drug Lumakras.
Richard Pazur, director of the FDA’s Center for Excellence and the FDA’s Acting Director of Oncological Diseases, said: “KRAS mutations are designed to treat patients with certain types of cancer who are really underdeveloped. Explained in a statement prepared for drug evaluation and research. Today’s approval represents a crucial step toward a future where many patients have access to personalized treatment.
A / KRAS A is part of the RAS genes that make up the playing proteins Role in cell signaling. These proteins are normally used as a switch to control cell growth. But when the KRAS is changed, that switch may stick to the “top” position, leading to uncontrolled cell growth.
KRAS proteins are difficult to treat because their structure does not have deep pockets to attach small molecules. Lumakras is a small molecule designed to bind to KRAS G12C, which is locked in an inactive state that prevents the proliferation of proteins during uncontrolled cell growth. The target method does not affect the unchanged KRAS.
Accelerated approval of Lumakras NCSL, led by KRAS G12C, was tested in 124 patients and treated with capillary control and / or chemotherapy based on the results of 2 studies.
The main goal of the open label study is to measure the response rate, the number of patients whose tumors have been destroyed or reduced, and the response time. According to the FDA, the target response rate was 36%. 58% of those who respond to treatment have a response that lasts for six months or more. Overall recovery information, it is planned that patients will still live longer after treatment Approached Next month at the annual meeting of the American Clinical Oncology Association.
The most common side effects of the test are diarrhea, muscle aches, nausea, fatigue, liver damage and coughing. According to the FDA, patients with moderate pneumonia, which causes scarring of the limbs, should be treated with leukemia. If the disease is diagnosed, the use of the drug should be stopped. If the liver is damaged, the FDA says the drug can be banned, reduced, or permanently discontinued.
Other companies are still pursuing KRAS-targeted drugs. Miracy Therapeutics is in the final stages of testing with a small molecule containing KRAS G12C. Mercury is producing small molecules to counteract the KRAS mutation under K Union It was launched last year with Thai medicine and acetaminophen.
Amgen aims to increase the use of Lumakras for other cancers. The company is testing a drug for stage 2 colorectal cancer. The clinic said the test was fully registered, with preliminary results expected by the end of this year. A KRAS G12C mutation is being compared to chemotherapy dosagex in SNS patients with a global level 3 study.
Approval of 960 mg of Lumakras arrived two months ago. The date for the decision was August 16. Accelerated approval based on the thinner evidence evaluated in the standard drug evaluation may require further clinical research to determine whether low-dose adherence may have the same effect.
Photo by Amgen