Accelerating the approval process for a potential breakthrough in colorectal cancer treatment
- Bristol Myers Squibb receives priority FDA review for expanded use of Krazati
- Application seeks approval for Krazati in combination with cetuximab for colorectal cancer patients
- Priority review designation shortens the review period
- Target action date set for June 21
Bristol Myers Squibb has been granted a priority review by the FDA for its application to expand the use of its cancer drug, Krazati. The application seeks approval for the combination of Krazati and cetuximab in the treatment of previously treated KRAS(G12C)-mutated locally advanced or metastatic colorectal cancer. The FDA grants priority review to medicines that have the potential to significantly improve the treatment of a serious disease, and this designation will shorten the review period. The target action date for Bristol Myers’ application is set for June 21. Krazati, which is the key asset of Mirati Therapeutics, was acquired by Bristol Myers in a deal that closed in January.
Factuality Level: 9
Factuality Justification: The article provides a straightforward report on Bristol Myers Squibb receiving a priority review from the FDA for expanded approval of its cancer drug Krazati in certain patients with colorectal cancer. It includes relevant details about the application, the FDA’s priority review process, and the target action date. The information presented is factual and objective without any digressions, misleading information, sensationalism, redundancy, or bias.
Noise Level: 3
Noise Justification: The article provides relevant information about Bristol Myers Squibb’s priority review from the FDA for its cancer drug Krazati in certain patients with colorectal cancer. It includes details about the application, the target action date, and the significance of the FDA’s priority review designation. The article stays on topic and does not contain irrelevant or misleading information. However, it lacks in-depth analysis, antifragility considerations, or accountability of powerful people, which prevents it from scoring higher.
Financial Relevance: Yes
Financial Markets Impacted: Bristol Myers Squibb
Presence Of Extreme Event: No
Nature Of Extreme Event: No
Impact Rating Of The Extreme Event: No
Rating Justification: The news article pertains to a financial company, Bristol Myers Squibb, and its cancer drug Krazati. There is no mention of an extreme event or its impact rating.
Public Companies: Bristol Myers Squibb (BMY)
Private Companies: Mirati Therapeutics
Key People: Colin Kellaher (Author)
Reported publicly:
www.marketwatch.com 
