FDA approves new colorectal cancer treatment

Published 17/01/2025, 15:23
FDA approves new colorectal cancer treatment
AMGN
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THOUSAND OAKS, Calif. - Amgen (NASDAQ:AMGN), a prominent biotechnology company with a market capitalization of $144.8 billion, has received FDA approval for LUMAKRAS® (sotorasib) in combination with Vectibix® (panitumumab) to treat adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC). This regimen is indicated for those who have undergone prior chemotherapy. The approval is grounded on the Phase 3 CodeBreaK 300 study, which showcased the combination’s efficacy in doubling progression-free survival (PFS) compared to standard-of-care (SOC) treatments.

The study contrasted LUMAKRAS at two dosage levels with SOC therapies in patients with chemorefractory KRAS G12C-mutated mCRC. Results indicated that LUMAKRAS 960 mg daily, paired with Vectibix, significantly improved median PFS and overall response rate (ORR) over SOC. The combination’s median overall survival (mOS) was not reached, and safety profiles were consistent with previous observations for both drugs. According to InvestingPro data, Amgen has demonstrated strong revenue growth of 21.25% over the last twelve months, reflecting its successful commercialization strategy.

KRAS G12C mutations are present in approximately 3-5% of colorectal cancers, underscoring the importance of FDA-approved biomarker testing to identify eligible patients for targeted therapies. The new treatment option is particularly significant for mCRC patients, as KRAS mutations have been associated with poor outcomes, and standard treatments have shown limited benefits.

The approval of this combination therapy provides a new avenue for patients with KRAS G12C-mutated mCRC, offering an approach to delay disease progression. This news is based on a press release statement from Amgen. InvestingPro analysis suggests the company is currently trading near its Fair Value, with a strong financial health score of GOOD. For deeper insights into Amgen’s financial metrics and growth potential, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.

In other recent news, biotechnology giant Amgen is under the spotlight with Goldman Sachs reiterating its Buy rating on the company’s stock, while RBC Capital Markets and Piper Sandler adjusted their price targets but maintained positive ratings. This follows Amgen’s robust revenue growth of 21.25% over the last twelve months and a strong late-stage pipeline of treatments. The company’s investigational treatment for obesity and type 2 diabetes, MariTide, is of particular interest, with Phase 2 trial data expected in the second half of 2025.

Analysts from Goldman Sachs met with Amgen’s management to discuss the company’s pipeline and operational strategies, highlighting the firm’s confidence in MariTide. Other significant assets in their pipeline include olpasiran, Uplizna, Tezspire, and bemarituzumab. RBC Capital Markets and Piper Sandler also emphasized the company’s ability to sustain growth through its established products and emerging pipeline.

These recent developments demonstrate analysts’ positive outlook on Amgen’s future. Key points of interest include the potential of MariTide, anticipated updates in 2025, and the company’s commitment to long-term growth and operational efficiency. In addition to these ratings, Amgen has announced a $1 billion investment in a second drug substance manufacturing facility in North Carolina, reflecting its commitment to environmental stewardship and manufacturing excellence.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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