FDA grants approval for Bristol Myers Squibb's Augtyro for solid tumours [Yahoo! Finance]
Bristol-Myers Squibb Company (BMY)
Last bristol-myers squibb company earnings: 2/6 07:05 am
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Source: Yahoo! Finance
tyrosine receptor kinase (NTRK)-positive locally advanced or metastatic solid tumours. The treatment is indicated for use in adult and paediatric patients aged 12 years and above with tumours when surgical resection could cause severe morbidity, and for those who have either progressed following treatment or lack satisfactory alternative therapies. The FDA approved Augtyro based on the outcomes from the Phase I/II TRIDENT-1 study. The trial assessed the drug's efficacy in adults with NTRK-positive solid tumours, demonstrating promising results in overall response rate and duration of response. However, the FDA's accelerated approval stipulates that continued authorisation may depend on further verification and description of clinical benefits from confirmatory trials. The open-label, multi-cohort trial was conducted globally across multiple centres assessing Augtyro's safety, tolerability, pharmacokinetics and anti-tumour activity. The study included patients who had not p
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BMY
Earnings
- 4/25/24 - Miss
BMY
Sec Filings
- 6/25/24 - Form 11-K
- 6/25/24 - Form 11-K
- 6/25/24 - Form 11-K
- BMY's page on the SEC website