FDA Approves Amgen's Lumakras/Vectibix for Metastatic Colorectal Cancer

Amgen's innovative combination therapy has received approval from the US Food and Drug Administration (FDA) for treating specific colorectal cancer patients. This therapy, which includes Lumakras (sotorasib) and Vectibix (panitumumab), is now sanctioned for adults with KRAS G12C-mutated metastatic colorectal cancer who have previously undergone chemotherapy treatments such as fluoropyrimidine, oxaliplatin, and irinotecan.

Colorectal cancer stands as the third most prevalent cancer worldwide, with around 1.8 million new diagnoses recorded in 2022. Although it primarily affects older individuals, this disease can manifest at any age. The FDA's approval was largely influenced by data from the CodeBreaK 300 trial, an open-label study that involved 160 patients. Participants were randomly assigned to receive either a 960mg or 240mg oral dose of Lumakras daily, in conjunction with a bi-weekly 6mg/kg intravenous dose of Vectibix, or were given the standard care (SOC) options of trifluridine/tipiracil or regorafenib.

The primary measure of efficacy in the study was progression-free survival (PFS). Patients receiving the 960mg dose of Lumakras with Vectibix exhibited a PFS of 5.6 months, in contrast to the SOC group, which had a PFS of just two months. However, the final PFS analysis for those on the 240mg Lumakras dose with Vectibix did not yield statistically significant results when compared to SOC.

Moreover, the FDA-recommended dosage of Lumakras, 960mg once daily combined with 6mg/kg of Vectibix every two weeks, showed an overall response rate of 26%, whereas the SOC group had no response. The median duration of this response was recorded at 4.4 months.

The FDA also approved Qiagen's companion diagnostic tool, the therascreen KRAS RGQ PCR Kit. This device is designed to help identify patients who could benefit from Amgen's combination therapy. This diagnostic advancement is crucial for tailoring treatment to individual patient needs, thus optimizing therapeutic outcomes.

This development closely follows Amgen's recent announcement of a significant investment in expanding its manufacturing capabilities in the United States. The company has committed $1 billion to establish a new drug substance production facility in North Carolina. This expansion is an addition to a previously announced $550 million investment in Holly Springs, increasing Amgen's total planned investment in the area to over $1.5 billion.

Amgen believes that this expansion will significantly boost its global biomanufacturing network. By leveraging decades of operational expertise and technological advancements, the company aims to ensure the consistent and efficient delivery of medicines to patients on a global scale.

In summary, Amgen's newly approved combination therapy represents a significant advancement for patients with KRAS G12C-mutated metastatic colorectal cancer. The FDA's approval, backed by robust clinical trial data, highlights the potential for improved treatment outcomes in this patient population. Concurrently, Amgen's substantial investments in manufacturing infrastructure underscore its commitment to meeting the growing demand for such innovative treatments worldwide.