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KRAS mutations occur in about 25% of cancer cases, mainly in lung, pancreatic and colorectal cancers, and are associated with very poor prognostognosmation.
, KRASG12C mutation is one of the most common KRAS mutations, specifically KRAS 12-bit glycine mutation is cysteine.
The mutation is found in lung adenocarcinoma in up to 13%, colorectal cancer in 3%, uterine cancer in 3%, and mesothelioma in 1%, pancreatic cancer (-lt;1%), cervical cancer (-lt;1%), bladder cancer (-lt;1%) and stomach cancer (lt;1%), there is also a low proportion of KRASG12C mutation.
regret that no effective KRAS inhibitors have been approved for 40 years, which makes it widely believed that KRAS cancer protein is an "innate" target.
sotorasib (AMG 510), the first KRASG12C inhibitor, has emerged, making it believe that KRAS mutation targeting therapy is no longer a dream.
phase II clinical study, codenta named CodeBreaK100, published in September, showed that in patients who had previously received chemotherapy and/or immunotherapy progression KRASG12C mutation NSCLC, sotorasib achieved an objective mitigation rate (ORR) of 32.2% and a disease control rate (DCR) of 88.1%, with a medium non-progression survival period of 6.3 months.
study also showed that sotorasib single-drug therapy can reduce tumor volume in some patients.
results are expected to enable Amgen to develop sotorasib as a new option for treating NSCLC and to work better with other anti-tumor drugs.
on Tuesday that it plans to submit a listing application for Sotorasib by the end of 2020.
has previously said it will discuss future plans with regulators and expects to start selling sotorasib next year.
's communication with the FDA gave Sotorasib regulatory privileges, and the FDA awarded the drug breakthrough therapy to local late stage or metastasis KRASG12C mutation NSCLC, which had been treated at least once before.
is working with Guardant Health and Qiagen to develop accompanying diagnostic technologies based on blood and tissue.
benefit from breakthrough therapy certification, sotorasib's listing application will be approved by the FDA, which will evaluate sotorasib through the Real-Time Oncology Review (RTOR) pilot program.
projects that are included in THER may take only a few weeks from the time information is submitted to the time it is approved.
Sotorasib's inclusion in the RTOR program is the result of communication with the FDA so far, and Sotorasib's compliance with the program requires the FDA to obtain its Top-line data before it can be determined.
decision will come days or weeks after the FDA gets its Top-line data.
once a variety is included in the RTOR program, the FDA schedules a conference call to discuss specific details such as an advance submission schedule.
6 to 9 weeks after communicating with the FDA, as part of the advance submission of data, companies are required to dynamically submit reports to the FDA, including validity Top-line data, toxicology studies, etc.
FDA schedules meetings based on these advance submissions, asking sponsors to provide additional analytical data or to provide initial feedback to sponsors.
by reviewing the data submitted in advance, the FDA can begin the review more effectively than it receives the full listing data.
the RTOR project is not just about speeding up approval.
, the FDA sees it as a way to deliver drugs to patients as early as possible while improving the quality of the review and balancing the review team's workload.
, Amjin is still ahead of its competitors in bringing KRAS drugs to market.
followed by Mirati, which released preliminary data on the treatment of NSCLC in October, plans to file a listing application in the second half of next year.
schedule, Amjin's Sotorasib will be approved by the FDA when Mirati's MRTX849 submits its listing application next year.
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