The world's first KRAS inhibitor!

On May 28, local time, Amgen announced that the U.
S.
Food and Drug Administration (FDA) has accelerated the approval of its KRAS G12C inhibitor LUMAKRAS™ (Sotorasib, R&D code AMG 510) for the market, for treatment that has received at least one early stage Systemic treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) adult patients with KRAS G12C mutation.

 This is the world's first anti-cancer therapy that targets any KRAS gene mutation.
It means that after more than 40 years of efforts by scientists, this modern medicine has made new progress in the fight against the "unable to drug" target KRAS! Lung cancer is one of the most common cancers in the world, and non-small cell lung cancer (NSCLC) accounts for about 80% of all lung cancers.

KRAS G12C is one of the most common driver mutations in NSCLC, accounting for 13%.

 AMG 510 is the world's first KRAS G12C covalent inhibitor to enter the clinical stage.
It can lock KRAS G12C in an inactive state, thereby inhibiting the activity of KRAS.

At the ASCO conference in 2019, this product astounded the audience with a 90% disease control rate and 50% effective data, and became the hottest anti-cancer drug of the year.

 The FDA approval of AMG 510 is based on data from the key Phase 2 clinical trial of CodeBreaK 100.

Among 124 NSCLC patients with KRAS G12C mutations, 960 mg AMG 510 was taken orally once a day, the objective response rate was 36%, the disease control rate was 81%, and the median duration of response was 10 months, and 58% of the patients continued to respond Time ≥ 6 months.

In terms of adverse reactions, the most common adverse reactions brought by AMG 510 are diarrhea, musculoskeletal pain, nausea, fatigue, liver toxicity and cough.

 The FDA recommends that medical staff should monitor the patient’s liver function test before the patient starts and take AMG 510.
If the patient develops liver damage, the product should be used with caution, and if the patient has symptoms of interstitial lung disease, the product should be stopped.
.

When taking AMG 510, patients should avoid taking acid-reducing agents, drugs that induce or act as substrates for certain liver enzymes, and drugs that act as substrates for P-glycoprotein.

 Dr.
David M.
Reese, Executive Vice President of Research and Development of Amgen, said: “The approval of LUMAKRAS is a breakthrough moment for patients with non-small cell lung cancer with KRAS G12C mutation
.
Finally ushered in a targeted drug.

The development of this clinical project, for Amgen’s scientists and clinical staff, is a race against cancer.
In 3 years!" Dr.
Richard Pazdur, Director of the Oncology Center of Excellence and 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, and there will be some in the future.
More cancer patients can have personalized treatment methods.

"It is reported that BeiGene has reached a cooperation with Amgen in 2019 to jointly develop AMG 510 in China.

Congratulations on the launch of AMG 510, and hope that this product will benefit more cancer patients! End reference materials: [1] FDA official website [2] Amgen's official website