FDA Approves Amgen Drug Sotorasib

The Food & Drug Administration approved the Amgen drug Sotorasib designed to target a gene mutation in patients with lung cancer. In the patients, the mutation of the non-small cell lung cancers occurs by 13 percent. The gene is known as KRAS that is found to worsen the disease post-chemotherapy or other medicines.

The drug Sotorasib will be commercially available in the U.S market under the brand name Lumakras. During the clinical trials, the Sotorasib was found to reduce the tumor mutation in around 36 percent of patients. The company’s drug will have a U.S. list price of $17,900 every month. Sotorasib is designed to target the KRAS G12C found in around 13 percent of non-small cell lung cancers that mutate the cancer cells. NSCLC is commonly occurring in lung cancer.

According to the information given by Amgen, around 25,000 U.S. patients will be eligible for the drug. KRAS is also found to mutate the cancer cells in colorectal and other cancers by 1% to 3%.The approval by the FDA is given for a daily dose of a 960-milligram pill. The FDA has also ordered Amgen to conduct post-approval clinical trials to see whether the drug can be administered in a lower dose.

The cancer-targeting drugs are usually developed at the highest tolerable dose. However, some oncologists have urged the FDA to recommend the drug makers optimize the amount. Usually, drug makers manufacture drugs for cancer therapeutics at the highest level of tolerance. However, recently, many oncologists are urging the FDA to enable further dose optimization.Lumakras has now become a precision medicine targeting the cancer cells regardless of any body part where the disease has originated.