FDA approves lung cancer drug #MPAR

June 3rd 2021

Recently, the FDA approved an Amgen drug, sotorasib, for non-small cell lung cancer (NSCLS) with a specific mutation in a gene known as Kirsten rat sarcoma viral oncogene homolog (KRAS) in patients whose disease has worsened after treatment with chemotherapy or other medicines. This mutation accounts for 13% of NSCLS—the most common form of lung cancer.

While the FDA announcement highlights the clinical trials that preceded approval of the drug/on which the drug was approved for use it failed to highlight the basic animal research that led to the discovery of KRAS as well as the animal research involved in safety and efficacy testing prior to clinical trials.

  • KRAS was “discovered” in 1967 during research into the mouse erythroblastosis virus in mice and rats
  • The first gene product of KRAS, p21 GTPase was found in 1979
  • The genetic sequence of the KRAS mouse and rats variants were produced in 1982
  • Decades of research into structure and function (e.g., here, here, here, here)
  • Understanding of the role of KRAS in cancers (e.g., here, here)
  • As part of the nonclinical safety assessment, sotorasib was evaluated in oral toxicology studies in the Sprague Dawley rat and the beagle dog

As can be seen above, decades of animal research (#timescales)  and animal testing for safety profiling led to this breakthrough. It is equally likely that further breakthroughs for various cancers will emerge given the associations between mutations in KRAS and other cancers. #MPAR

~Speaking of Research