PRINCETON, N.J. - The U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application for KRAZATI® (adagrasib) in combination with cetuximab, a treatment for KRAS G12C-mutated colorectal cancer, and set a target action date of June 21, 2024. Bristol Myers Squibb (NYSE: NYSE:BMY) shared this development today, indicating the agency's priority review status of their application.
This decision by the FDA is based on the outcomes of the Phase 1/2 KRYSTAL-1 study, which assessed the efficacy and safety of KRAZATI alone or in combination with other treatments in patients with advanced solid tumors with the KRAS G12C mutation. The study's primary goal was to measure the objective response rate, with secondary endpoints including the duration of response, progression-free survival, overall survival, and safety.
The results showed that KRAZATI, when used with cetuximab, was well-tolerated and demonstrated promising clinical activity in patients with previously treated, locally advanced, or metastatic colorectal cancer with the KRAS G12C mutation. The safety profile was consistent with the known profiles of the individual drugs.
KRAZATI is a highly selective oral inhibitor targeting the KRAS G12C mutation, which is present in various cancer types, including 3-4% of colorectal cancers. The drug was previously granted accelerated approval for treating certain cases of non-small cell lung cancer and has received breakthrough therapy designation for its combination with cetuximab for advanced colorectal cancer.
The FDA's acceptance of the application does not guarantee approval but is a critical step towards potentially offering a new treatment option for patients with limited alternatives.
The information presented here is based on a press release statement from Bristol Myers Squibb.
InvestingPro Insights
Amidst the news of FDA's acceptance of Bristol Myers Squibb's (NYSE: BMY) supplemental new drug application for KRAZATI®, the company's financial health and market performance provide additional context for investors. A key InvestingPro Tip for BMY is that the company has been aggressively buying back shares, a move that often reflects management's confidence in the company's future prospects and can be seen as a positive signal to investors.
Furthermore, Bristol Myers Squibb's commitment to rewarding shareholders is evidenced by its high shareholder yield, which is bolstered by the company's impressive track record of maintaining dividend payments for 54 consecutive years. This consistency in returning value to shareholders can be particularly attractive to those looking for stable income-generating investments.
Analyzing the latest InvestingPro Data, BMY's market capitalization stands at $100.83 billion, with a P/E ratio of 12.92, reflecting a valuation that is trading at a low multiple relative to near-term earnings growth. The company's strong free cash flow yield is indicated by an adjusted P/E ratio for the last twelve months as of Q4 2023 of 10.69. Additionally, Bristol Myers Squibb's dividend yield as of early 2024 is a robust 4.81%, a figure that is sure to catch the eye of dividend investors.
For readers interested in a deeper dive into Bristol Myers Squibb's financials and market performance, InvestingPro offers a wealth of additional tips—10 more to be precise. By using the coupon code PRONEWS24, investors can get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking further insights that can aid in making informed investment decisions.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.