PRINCETON, N.J. – Bristol Myers Squibb (NYSE: NYSE:BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) announced the recent approval by the U.S. Food and Drug Administration (FDA) of Abecma® (idecabtagene vicleucel) for adult patients with relapsed or refractory multiple myeloma.
The approval, dated April 4, 2024, allows the use of Abecma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
This decision was based on the results of the KarMMa-3 trial, which showed that Abecma tripled progression-free survival compared to standard regimens, with a 51% reduction in the risk of disease progression or death. The one-time infusion of Abecma is now available to a broader group of patients earlier in their treatment journey, offering meaningful treatment-free intervals for those responding to therapy.
Abecma’s expanded approval marks its availability in the U.S., Japan, Switzerland, and the European Union for earlier use in triple-class exposed relapsed and/or refractory multiple myeloma. Bristol Myers Squibb has emphasized its commitment to global access and has reported a 94% manufacturing success rate with continuous capacity increases.
The KarMMa-3 trial was a pivotal, Phase 3, open-label, global, randomized, controlled trial that evaluated Abecma in comparison to standard regimens in patients with relapsed and refractory multiple myeloma who had received two to four prior lines of treatment and were refractory to the last regimen. The study allowed for crossover from standard regimens to Abecma upon confirmed disease progression.
Abecma demonstrated a median progression-free survival of 13.3 months versus 4.4 months for standard regimens. Moreover, it showed a significant improvement in overall response rates, with 71% of patients treated with Abecma achieving a response and 39% achieving a complete or stringent complete response.
The safety profile of Abecma in the trial was well-established, with mostly low-grade cytokine release syndrome and neurotoxicity. The companies have made continuous investments to support the approval and future expansions of Abecma.
This information is based on a press release statement from Bristol Myers Squibb and 2seventy bio, Inc.
InvestingPro Insights
Bristol Myers Squibb's (NYSE: BMY) recent FDA approval for Abecma® marks a significant milestone in the treatment of multiple myeloma and reflects the company's dedication to advancing healthcare. As investors consider the impact of this development on the company's financial health, key metrics from InvestingPro offer insights into Bristol Myers Squibb's current market standing.
The company's market capitalization stands strong at $104.18 billion, underpinning its significant presence in the pharmaceutical industry. Trading at a P/E ratio of 13.21, which adjusts to a lower 11.04 on a last twelve months basis as of Q4 2023, Bristol Myers Squibb appears to be valued attractively in comparison to its near-term earnings growth. This is further bolstered by a PEG ratio of only 0.42, suggesting that the stock could be undervalued based on its earnings growth potential.
Investors should note the company's high shareholder yield and aggressive share buyback strategy, as highlighted by InvestingPro Tips. Such activities often signal management's confidence in the company's future prospects and can be a positive sign for investors looking for stable returns. Additionally, with a strong free cash flow yield implied by its valuation, Bristol Myers Squibb demonstrates the potential for robust financial flexibility and the ability to invest in future growth opportunities.
For those interested in further analysis and additional InvestingPro Tips, including the company's low price volatility, position as a prominent player in the Pharmaceuticals industry, and its impressive 54-year history of dividend payments, a visit to https://www.investing.com/pro/BMY is recommended. There, you will find 8 more tips that could help inform your investment decisions. Remember to use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking even more valuable insights.
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