date, the FDA has approved two KRASG12Cinhibitors, sotorasib and adagrasib, for the treatment of patients with KRASG12C-driven cancers. Researchers have paid close attention to the development of inhibitors for other KRAS mutations and upstream regulatory factors. The KRAS targeted drug ...
FDA Accelerated Approval of Adagrasib for Non-Small Cell Lung Cancerdoi:10.1097/01.COT.0000920672.35654.a1Dibash Kumar DasWolters Kluwer Health, Inc.Oncology Times
The FDA has accepted a supplemental new drug application (sNDA) for priority review seeking the approval of adagrasib (Krazati) in combination with cetuximab (Erbitux) for patients with previously treated, locally advanced or metastatic KRAS G12C–mutated colorectal cancer (CRC).1...
“The accelerated approval of KRAZATI from the FDA in 2022 was welcome news for patients with KRASG12C-mutated locally advanced or metastatic NSCLC. These confirmatory results further support KRAZATI as an efficacious, targeted treatment option for these patients,” said Abderrahim Oukessou, M.D....
The FDA provided KRAZATI Accelerated Approval (Subpart H), allowing for the approval of drugs that treat serious conditions, and that fill an unmet medical need based on surrogate endpoints. KRAZATI was also granted a conditional marketing authorization by the United Kingdom's Medicines and Health...
months, just barely beating the LUMAKRAS’ 12.5 months. However, adagrasib is being considered by the FDA, with the decision date expected in mid-December, which still puts Mirati long behind Amgen (about 19 months). Because KRAS G12C mutation continues to multiply, researchers anticipate tha...
In the U.S., KRAZATI was approved by the FDA for Accelerated Approval (Subpart H), which allows for the approval of drugs that treat serious conditions, and that fill an unmet medical need based on surrogate endpoints. KRAZATI was reviewed under the FDA Real-Time Onco...
In the U.S., KRAZATI was approved by the FDA for Accelerated Approval (Subpart H), which allows for the approval of drugs that treat serious conditions, and that fill an unmet medical need based on surrogate endpoints. KRAZATI was reviewed under the FDA Real-Time Onc...