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Because the G12C KRAS mutation is relatively common in some cancer types, 14% of non-small-cell lung cancer adenocarcinoma patients and 5% of colorectal cancer patients, [15] and sotorasib is the first drug candidate to target this mutation, there have been high expectations for the drug.
In June 2024, the US FDA granted accelerated approval to adagrasib plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. [10] [11]
Cobimetinib or XL518, approved by US FDA in Nov 2015 for use in combination with vemurafenib (Zelboraf(R)), for treatment of advanced melanoma with a BRAF V600E or V600K mutation. Selumetinib , had a phase 2 clinical trial for non-small cell lung cancer (NSCLC) which demonstrated an improvement in PFS, [ 5 ] and is now in phase III development ...
The approval under the agency's accelerated process was based on an early- to mid-stage study, in which 94 previously treated patients were administered the oral drug Krazati, in combination with ...
Lumakras, which bought in sales of $285 million last year, targets a mutated form of a gene known as KRAS that occurs in about 13% of non-small cell lung cancers - the most common form of the disease.
mTOR inhibitors are a class of drugs used to treat several human diseases, including cancer, autoimmune diseases, and neurodegeneration. They function by inhibiting the mammalian target of rapamycin (mTOR) (also known as the mechanistic target of rapamycin), which is a serine/threonine-specific protein kinase that belongs to the family of phosphatidylinositol-3 kinase (PI3K) related kinases ...
Drug Manufacturer Indication Adagrasib: In combination with cetuximab for the treatment of adults with KRAS G12C mutated locally advanced or metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy [2]
The drug was approved by the FDA in 2021 under an accelerated pathway, with confirmatory data a condition for gaining traditional approval. The main goal of the confirmatory study was progression-fre