FDA accepts NDA for non-small cell lung cancer treatment
pharmafile | February 17, 2022 | News story | Business Services |
Mirati Therapeutics, a clinical-stage targeted oncology company has announced that the FDA has accepted the new drug application (NDA) for adagrasib for the treatment of patients with non-small cell lung cancer (NSCLC), with tumours that have a KRAS G12C mutation, who have previously received at least 1 therapy.
The KRAS G12C mutation is the most common genetic abnormality associated with non-small cell lung cancer (NSCLC). It is believed to develop as a result of genetic alterations that occur in the body due to smoking. The KRAS G12C gene abnormality induces growth, and rapid spread, of cancer.
The detection of KRAS G12C mutation as a biomarker can provide insight into the prognosis of the disease, as well as its response to treatment.
“The acceptance of our NDA for adagrasib is a significant step forward in Mirati’s ongoing efforts to advance innovative, differentiated treatment options for patients with KRAS G12C cancers,” said Charles Baum, MD, PhD, president, founder and head of research and development at Mirati Therapeutics, Inc, in a press release. “We look forward to working with the FDA during their review of our application and potentially provide a novel option for patients with non-small cell lung cancer.”
The NDA will undergo a traditional FDA review and has been given a Prescription Drug User Fee Act target action date of December 14, 2022.
Adagrasib is an investigational and highly selective oral small-molecule inhibitor used for the treatment of patients with non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation.
“KRAS mutations have been notoriously hard to target and historically have had limited therapeutic options,” said Pasi A. Jänne, MD, PhD, a KRYSTAL-1 investigator and director of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, in a press release. “The KRAS G12C biomarker in particular is associated with poor survival outcomes. The FDA’s review of the adagrasib NDA marks important progress toward potentially providing a new, targeted option for those living with KRAS G12C–mutated NSCLC.”
Ana Ovey
