Amgen submits KRAS inhibitor AMG 51...

On December 16, Amgen announced that it had submitted to the FDA an application for the listing of KRASG12C inhibitor sotorasib (AMG 510) for the treatment of locally advanced or metastasis non-small cell lung cancer (NSCLC) with KRASG12C mutations that have been systematically treated at least once in the past.
benefit from breakthrough therapy certification, sotorasib's listing application will be approved by the FDA for accelerated approval and the FDA will evaluate sotorasib through Real-Time Oncology Review (RTOR).
projects that are included in THER may take only a few weeks from the time information is submitted to the time it is approved.
this filing is based on a Phase I/II clinical study code-named CodeBreaK 100.
study, sotorasib therapy showed long-lasting anti-tumor activity and positive clinical benefits.
In patients who had previously received chemotherapy and/or immunotherapy disease progression KRASG12C mutation NSCLC, sotorasib achieved an objective remission rate (ORR) of 32.2% and a disease control rate of 88.1% (DCR) with a medium progression-free survival of 6.3 months.
study also showed that sotorasib single-drug therapy can reduce tumor volume in some patients.
results are expected to make sotorasib a new option for treating NSCLC and to be linked to other anti-tumor drugs to produce better outcomes.
results will be published at the 2020 World Lung Cancer Congress (WCLC) in January 2021 at the International Lung Cancer Research Association.
the development of KRASG12C mutation inhibitors, which Amjin is engaged in, is one of the most daunting challenges for humans in nearly 40 years.
Sotorasib is the first product to enter the clinical phase and extensive clinical studies are currently under way.
development projects in 10 countries and regions on 4 continents.
in just over two years, the Sotorasib Clinical Project has established in-depth clinical data sets covering 13 tumor types and more than 600 patients.
source: Pharmaceutical Rubik's Cube NextPharma Amjin is ahead of its competitors in bringing KRAS drugs to market.
followed by Mirati, which released preliminary data on MRTX849's treatment of NSCLC in October, plans to file a listing application in the second half of next year.
schedule suggests that Amjin's Sotorasib could be approved by the FDA when Mirati's MRTX849 submits its listing application next year.
in China, Amjin has submitted two clinical studies to NMPA since March this year, all of which have been approved for clinical use.
KRAS mutation occurs in about 25% of cancer cases, mainly in lung, pancreatic and colorectal cancers, and is associated with very poor disease prognostoficity.
, 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.
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