“KRAS mutations have long been considered resistant to drug therapy, representing a true unmet need for patients with certain types of cancer,” said Richard Pazdur, M.D., Director of the FDA’s Oncology Center of Excellence
FDA has recently approved Sotorasib to treat KRAS G12C-mutated non-small cell lung cancer. This newly invented targeted therapy is a boon for the patients with KRAS mutated non-small cell lung cancer (NSCLC), who have achieved a poor prognosis following first-line treatment and are left with limited treatment choices.
KRAS is one of the frequently found mutated genes in patients with NSCLC. It is detected in approximately 30% of lung adenocarcinomas and is a target for researchers. It was known to be the first oncogene (a mutated form of a normal gene that causes cancers) ever diagnosed (1983). For the past 40 years, this elusive kind of KRAS has scuppered the drug developers.
Recently, a breakthrough success has been achieved in the field of knocking the KRAS gene down. The largest clinical trial has been operated to date for determining the outcomes of Sotorasib, particularly for patients with KRAS G12C mutation. The trial involved 124 patients with KRAS 12C mutated metastatic or locally advanced NSCLC, who showed disease progression following chemotherapy or immunotherapy.
The patients were administered with 960 mg of Sotorasib orally once daily. After treatment, the drug showed an overall response rate of 36%. The percentage of patients who achieved disease control following treatment was 81%. The median duration of response was found to be ten months.
A total of 9% of patients permanently discontinued the treatment due to adverse reactions. The most common side effects noticed during the trial were nausea, fatigue, cough, diarrhoea, hepatotoxicity and musculoskeletal pain.
However, Sotorasib presents a significant development in oncology and entirely turns the treatment paradigm for KRAS G12C-mutated non-small cell lung cancer. The efficacy of Sotorasib can further help in the development of novel drugs to control other unmanageable oncogenes.
|Orginal Title of the Article||FDA Approves First Targeted Therapy for Lung Cancer Mutation Previously Considered Resistant to Drug Therapy|