Larotrectinib

ANGLE presented breakthrough data at EACR 2025 demonstrating DNA dual analysis combining CTC-DNA and ctDNA from single blood samples, revealing 53% of mutations found exclusively in CTCs in lung cancer patients.

Comprehensive genomic profiling is crucial for brain cancer patients, enabling personalized treatment approaches and identification of actionable mutations like NTRK fusions, according to Dr. Manmeet Ahluwalia.

• FDA has announced plans to eliminate mandatory animal testing requirements for monoclonal antibodies and certain other pharmaceutical products, marking a significant shift in drug development regulations. • The announcement comes amid broader regulatory changes at FDA, including recent approvals of cancer treatments such as nivolumab with ipilimumab for hepatocellular carcinoma and durvalumab for muscle invasive bladder cancer. • HHS Secretary Robert F. Kennedy Jr. framed these changes as part of a "generational opportunity" to reform the regulatory agency, while the department undergoes significant restructuring with personnel cuts and division consolidations.

• Caris Life Sciences published a groundbreaking study in Nature Communications analyzing over 295,000 cancer patients, revealing that more than 20% are eligible for tissue-agnostic "pan-cancer" therapies targeting specific molecular features rather than tumor location. • The research uncovered significant variability in treatment efficacy across different cancer types, challenging the notion that tissue-agnostic therapies work equally well in all tumors and suggesting potential for expanding approvals to other drugs in the same class. • Despite proven efficacy, the study found poor clinical uptake of tissue-agnostic therapies for rare indications, highlighting the need for enhanced physician education about these powerful treatment options.

• The European Medicines Agency (EMA) has approved Vitrakvi (larotrectinib) as the first-ever tumor-agnostic therapy, treating cancers based on molecular signatures rather than tumor location. • The drug targets rare NTRK gene fusion cancers affecting several thousand European patients annually, particularly prevalent in sarcomas, brain, kidney, and thyroid cancers. • Bayer's Vitrakvi leads the European market ahead of competitor Roche's Rozlytrek, with approvals already secured in the US, Brazil, and Canada.