LUMAKRAS™ (Sotorasib) Now Approved for the Treatment of Adult Patients with KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

On June 4, 2021 Onco360, the nation’s largest independent Oncology Pharmacy, reported that it has been selected by Amgen to be a specialty pharmacy partner for LUMAKRAS (sotorasib), a new oral treatment for 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 (Press release, Onco360, JUN 4, 2021, View Source [SID1234583589]).

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"Onco360 is honored to be selected as a specialty pharmacy provider for LUMAKRAS in partnership with Amgen," said Benito Fernandez, Chief Commercial Officer, Onco360. "The recent approval of LUMAKRAS unlocks the first FDA-approved treatment option for patients with previously treated advanced or metastatic KRAS G12C-mutant NSCLC. As a provider of this key treatment, Onco360 is committed to supporting the highly specialized needs of NSCLC patients."

ABOUT METASTATIC NON-SMALL CELL LUNG CANCER

According to the National Cancer Institute’s (NCI’s) Surveillance, Epidemiology, and End Results (SEER) program, 235,760 patients will be diagnosed with lung cancer in 2021, with a corresponding 131,880 deaths. When considering all stages and histologic subtypes of the disease, the five-year overall survival (OS) of lung cancer is 21.7%. Patients with Stage IV metastatic disease have a five-year OS of only 6.3%. Unfortunately, 56% of lung cancer patients have metastatic disease upon initial diagnosis. Up to 85% of lung cancer cases are classified as NSCLC.1 Approximately 13% of NSCLC patients have KRAS G12C mutations.2

LUMAKRAS is manufactured by Amgen, a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer. The FDA’s approval of LUMAKRAS comes as a result of a 124 patient subset of the Phase I/II CodeBreak 100 clinical trial (NCT03600883) which demonstrated that previously treated patients with metastatic KRAS G12C-mutant NSCLC experienced a 36% objective response rate (ORR) after LUMAKRAS ad