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A New Era of Lung Cancer Treatment is Here: KRAS Gene Variant Lung Cancer Drug Obtains FDA Approval

TAIPEI, TAIWAN, Jul. 30, 2021 – As of May 28th 2021, the field of Gene Medicine has had a historical breakthrough for the development of medicine that paves a brighter future for cancer treatment. Amgen’s new medication, Lumakras (official drug name, Sotorasib), for lung cancer caused by KRAS mutations became FDA-approved, after evaluating the data from the second phase of the CodeBreak100 clinical trial. Moreover, the FDA also approved the CDx blood and tissue based companion diagnostic tests for the KRAS mutation identification in tumors, which were developed under the collaborative efforts of Amgen, Qiagen and Guardant. In specific, Guardant360 CDx sequencing tests detect mutations in blood plasma samples, and the Therascreen KRAS RGQ PCR tissue kit analyzes tumor tissue. These diagnostic tools are used to screen patients for the potential new drug. In accordance with FDA regulations, when mutations cannot be detected by the Guardant360 in blood samples, then Doctors must use the Therascreen KRAS RGQ PCR kit to further test for related mutations in tumor tissues. KRAS targeted therapy has been refined over the course of the last few decades. Many patients today have limited treatment options, and they are desperately in need of this targeted treatment option because KRAS mutations are often resistant to traditional drug therapy.

KRAS Variants and Why They Have Been so Challenging

Truly revolutionary, Lumakras is the first FDA approved drug which can treat various types of KRAS mutation cancers and can specifically treat non-small cell lung cancer (NSCLC), which is caused by the KRAS p.G12C genetic mutation. The KRAS mutation is the most common oncogene mutation, and is present in 13% of lung cancer cases. Up to 20% of all cancerous mutations are related to the KRAS variants and unfortunately, there is no known cure to this date due to the difficulty in finding the appropriate drug binding site. One of the primary reasons why the KRAS p.G12C variant is particularly difficult to treat with all prior drug treatments can be attributed to the limited number of protein surface features this variant and other KRAS variants have. Protein surface features are points of genetic contact. Drugs that have been developed to treat this variant are inhibitors.

Defying the Odds with Inhibitor Drugs

These inhibitors are designed to target the mutation and inhibit its expression. There have been several failed attempts to develop such inhibitor drugs due to these difficulties. However, Lumakras is proving to be defying those odds with its high treatment success rates. Given there are no available drugs for patients' needs, the new drug Lumakras was granted priority review and was approved as a breakthrough therapy and was designated as an orphan drug by the FDA. According to results emerging from the interim clinical trial, patients treated with Lumakras had a disease control rate of 81% with an objective remission rate of 36%. It truly can not be overstated that these results are borderline unprecedented within a field that has been trying to reach this goal for such a long time. And this goal will change so many lives if this drug proves to remain as successful as these preliminary results have been.


This legendary collaboration between Amgen, Qiagen and Guardant has brought one of the most promising precision gene therapies in the history of the field. It shows what is possible by having the field of molecular medicine establish a multi-stage gene therapy, non-invasive blood diagnosis, and invasive tumor tissue diagnosis. Therefore providing clinically effective and feasible methods for molecular diagnosis and treatment, bringing new hope to clinical genetic medicine. We here at WASAI, as a bioinformatics company, see these advancements and innovations as truly promising. Breakthroughs like this show that there is so much potential for new treatment options against some of the worst ailments to plague humanity.


About WASAI Technology Inc.

WASAI Technology's mission is to deliver acceleration technologies of High-Performance Data Analysis (HPDA) in future data centers for targeted vertical applications with massive volumes and high velocities of scientific data. To strengthen and advance scientific discovery and technological research via big data-intensive acceleration in high-performance computing, WASAI Technology aims to improve commercialization and commoditization of scientific and technological applications.



WASAI Tecnology Inc.

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