U.S – The Food and Drug Administration has approved a targeted therapy drug by AMGEN INC for non-small cell lung cancer with a specific mutation in a gene known as KRAS.
The drug, sotorasib, which will be sold under the brand name Lumakras, shrank tumours with the KRAS mutation in around 36 percent of patients in clinical trials.
This medication is designed to target a gene mutation known as KRAS G12C that occurs in about 13 percent of non-small cell lung cancers, or NSCLC, the most common type of lung cancer.
Lung cancer is the most common cancer type with a high mortality rate. This can be attributed to genetic mutations that cause it. KRAS is a type of mutation in a group of genes that regulate cell growth and division.
Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said there has been an unmet need among cancer patients suffering from KRAS mutations which have been long considered as drug resistant.
“This approval represents a significant step towards a future where more patients will have a personalized treatment approach,” said Pazdur.
The 960-milligram dose drug which was approved two months before the FDAs expected decision date will still be required to go through trials investigating whether a lower dose would be effective.
Cancer drugs are typically developed at the highest tolerable dose, but some oncologists have urged the FDA to do more to require drug makers to optimize dosing.
Lumakras is part of a growing trend of precision medicines that target gene mutations driving cancer regardless of which organ the disease originated. This approach is expected to grow into a means of treatment for all types of cancer.
Along with Lumakras, the FDA also approved the QIAGEN therascreen KRAS RGQ PCR kit and the Guardant360 CDx as companion diagnostics for Lumakras today.
The QIAGEN GmbH test analyses tumour tissue and the Guardant Health, Inc. test analyses plasma specimens to determine if Lumakras is an appropriate treatment for patients.
Amgen is also seeking regulatory approval of Lumakras in Europe, Japan and several other jurisdictions.