Onco360, the nation’s leading independent Specialty Pharmacy, has been selected by Mirati Therapeutics to be a specialty pharmacy partner for KRAZATI, which is an inhibitor of the RAS GTPase family indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification of a clinical benefit in a confirmatory trial.
“Onco360 is honored to partner with Mirati Therapeutics and become a specialty pharmacy provider for KRAZATI patients”
“Onco360 is honored to partner with Mirati Therapeutics and become a specialty pharmacy provider for KRAZATI patients,” said Benito Fernandez, Chief Commercial Officer, Onco360. “We are dedicated to supporting the highly specialized needs of patients battling previously treated, advanced NSCLC with KRAS G12C mutations across the United States.”
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According to the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program, it is estimated that 236,740 new cases of lung cancer will be diagnosed in 2022 in the United States with a corresponding 130,180 deaths in 2022. Up to 85% of all lung cancers are histologically NSCLC. When considering all stages and histologic subtypes of lung cancer, five-year overall survival (OS) is only 22.9%. Unfortunately, 56% of lung cancer patients already have metastatic disease upon initial diagnosis. Patients with metastatic lung cancer have a dismal five-year OS of 7%. Approximately 13% of NSCLC patients are found to have KRAS G12C mutations.
KRAZATI is commercialized by Mirati Therapeutics. The FDA approval of KRAZATI is based on results from the registration-enabling Phase 2 cohort of the KRYSTAL-1 (NCT03785249) study evaluating KRAZATI 600 mg twice daily in patients with non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation who have received at least one prior systemic therapy. The KRYSTAL-1 Phase 2 cohort showed that KRAZATI administration resulted in a 42.9% objective response rate (ORR) in the study population. The most common adverse reactions (≥20%) are diarrhea, nausea, fatigue, vomiting, decreased appetite, dizziness, and QT prolongation.
SOURCE: Businesswire