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Lumakras approved to treat KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults

A combination treatment that pairs US Biotech Amgen Inc’s KRAS-blocking drug Lumakras with another of its targeted cancer medicines has shown improved tumor response rates in patients with advanced colon cancer, the company. Of the 2.2 million new lung cancer cases diagnosed each year globally, about 84% are of the NSCLC type.

Lumakras won accelerated regulatory approval to treat KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults. The FDA approval was based on the outcome of the CodeBreak 100 clinical trial program.

Amgen secured the Food and Drug Administration (FDA), U.S’s approval of Lumakras in May 2021 to treat patients with lung cancer caused by a genetic mutation to the KRAS protein.

Amgen described its work on Lumakras as a race against cancer, noting that its team and clinical investigators managed to bring this new treatment to patients in less than three years, according to Yahoo Finance News

This revolutionary treatment has taken decades of research to reach the clinic, and now that it is here this new targeted drug will be available for eligible people with lung cancer as quickly as possible.

Charles Swanton, the chief clinician at charity Cancer Research UK, said the drug was “one of the most exciting breakthroughs in lung cancer treatment in 20 years, targeting a cancer gene that was previously untargetable.”

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The Developed KRAS improves the anti-tumour efficacy of chemotherapy and targeted agents

KRAS is the most frequently mutated oncogene in cancer and encodes a key signalling protein in tumours. The KRAS (G12C) mutant has a cysteine residue that has been exploited to design covalent inhibitors that have promising preclinical activity using novel binding interactions to markedly enhance their potency and selectivity in optimizing a series of inhibitors. In preclinical analyses, treatment with AMG 510 led to the regression of KRAStumours and improved the anti-tumour efficacy of chemotherapy and targeted agents.

Furthermore, in clinical trials, AMG 510 demonstrated anti-tumour activity in the first dosing cohorts and represents a potentially transformative therapy for patients for whom effective treatments are lacking.

“KRAS has challenged cancer researchers for more than 40 years with many deeming it as ‘undruggable’,” said Amgen’s head of research and development, David Reese.

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Lung cancer patients in England to receive the gene-mutated Amgen drug

In September last year, England’s health service announced that lung cancer patients in England will become the first in Europe to receive a drug made by U.S. biotech Amgen Inc. that targets a specific gene mutation.

NHS England also said it was fast-tracking lung cancer drug Sotorasib after it was shown in clinical trials to stop lung cancer progression for seven months.

The drug, taken as a tablet, will be used on patients with the KRAS G12C mutation that occurs in about 13% of non-small cell lung cancers (NSCLC), the most common type of lung cancer.

The early-access deal will see 600 patients a year receive Sotorasib in England through the state-run National Health Service (NHS).

US Biotech Amgen Inc. has sought regulatory approval for the drug in many other jurisdictions outside the U.S. including Canada, Japan, Australia, the U.K., and the E.U.

The drug price of $17,900 per month, as of May 2021, was deemed a fair price.

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