PRINCETON, N.J. - Bristol Myers Squibb (NYSE: NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Augtyro™ (repotrectinib) as a treatment for certain patients with solid tumors. This new indication applies to adult and pediatric patients aged 12 and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic, or where surgical resection would result in severe morbidity, and who have progressed following treatment or have no satisfactory alternative therapy.
The approval is based on the Phase 1/2 TRIDENT-1 study, which showed positive results in patients with NTRK-positive solid tumors. In the study, 58% of TKI-naïve patients had a confirmed objective response rate, with 83% of them still responding after one year. TKI-pretreated patients had a 50% response rate, with 42% still responding at one year.
Augtyro has been associated with central nervous system effects, interstitial lung disease/pneumonitis, hepatotoxicity, and other adverse reactions. The safety and efficacy of Augtyro in pediatric patients younger than 12 years of age have not been established.
This is the second indication for Augtyro in the U.S., following its full approval in November 2023 for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). The continued approval for this new indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
The recommended dose for Augtyro is 160 mg orally once daily for 14 days followed by 160 mg twice daily until disease progression or unacceptable toxicity. The prescribing information includes warnings and precautions related to potential adverse reactions, and the drug's safety profile was evaluated in 426 patients in the TRIDENT-1 trial.
Dr. Alexander Drilon, TRIDENT-1 global trial lead and Chief of the Early Drug Development Service at Memorial Sloan Kettering Cancer Center, emphasized the importance of having additional treatment options for patients with NTRK fusion-positive tumors. Susan Spinosa, president and patient co-founder of NTRKers, a patient advocacy group, expressed excitement about the new targeted therapy option for patients with NTRK-positive gene fusions.
In other recent news, Bristol Myers Squibb has made significant strides in its drug development and approval process. The FDA has approved Breyanzi, a Bristol Myers Squibb product, for broad lymphoma treatment. This approval extends Breyanzi's indication as the only CAR T cell therapy to cover four distinct subtypes of non-Hodgkin lymphoma. In addition, the European Commission has approved the use of Opdivo, another Bristol Myers Squibb drug, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
In a separate development, Bristol Myers Squibb and Sanofi (NASDAQ:SNY) have been ordered to pay over $916 million to the state of Hawaii due to allegations of failure to adequately warn non-white patients about potential health risks associated with the blood thinner Plavix. Both companies plan to appeal the decision.
Furthermore, the FDA has set a goal date of December 29, 2024, for the review of Bristol Myers Squibb's subcutaneous formulation of Opdivo, co-formulated with Halozyme (NASDAQ:HALO)'s recombinant human hyaluronidase. If approved, this could become the first subcutaneously administered PD-1 inhibitor.
Lastly, Citi has maintained its Buy rating on Bristol Myers Squibb stocks, following a comprehensive review of the company's recent sales, prescription data, and currency movements. Despite a scaled-back outlook for the company's immunology offerings, Citi's overall stance on the stock remains positive, citing the company's financial health and the potential of its pipeline.
InvestingPro Insights
Bristol Myers Squibb (NYSE: BMY) has recently garnered attention with the FDA's accelerated approval of Augtyro™, marking a positive step for the company and its stakeholders. As investors consider the potential impact of this development on the company's financial health and stock performance, several InvestingPro metrics and tips provide a deeper understanding of Bristol Myers Squibb's current standing.
InvestingPro Data highlights a market capitalization of $84.04 billion, reflecting the company's significant presence in the pharmaceutical industry. Moreover, the company's dividend yield stands at an attractive 5.66%, which is particularly noteworthy for income-focused investors. This metric is complemented by the fact that Bristol Myers Squibb has maintained dividend payments for 54 consecutive years, illustrating a strong commitment to shareholder returns.
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This information, combined with the company's latest FDA approval news, could suggest a potentially favorable outlook for Bristol Myers Squibb, as it continues to be a prominent player in the Pharmaceuticals industry.
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