Amgen, Inc. (AMGN) a biopharmaceutical company on Friday, announced that the FDA has approved LUMAKRAS or sotorasib in combination with Vectibix or panitumumab for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer or mCRC who have previously received chemotherapy.
The approval was based on the results of the pivotal Phase 3 CodeBreaK 300 study, in which LUMAKRAS plus Vectibix demonstrated superior progression-free survival or PFS compared to the standard-of-care treatments.
Patients treated with the combination therapy had a median PFS of 5.6 months, more than double the 2 months observed with the investigator's choice of care.
This combination therapy provides a new targeted treatment option for patients with KRAS G12C-mutated mCRC, a condition with historically poor outcomes and limited treatment options.
The approval also underscores the significance of KRAS G12C as a biomarker, as the combination therapy represents the first and only targeted treatment for this mutation to show improved PFS in this patient population.
LUMAKRAS is also approved for use in non-small cell lung cancer or NSCLC and continues to make strides in providing personalized treatment options for patients with actionable genetic mutations.
LUMAKRAS sales increased 88% year-over-year to $98 million in the third quarter of 2024 driven by volume growth and favorable changes to estimated sales deductions.
Cash position:
The company had a cash and investments totaled $9.0 billion and debt outstanding totaled $60.4 billion as of September 30, 2024.
Currently, AMGN is trading at $273.50 up by 1.56%.
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