Bayer Initiates US Recall of TRK Inhibitor Vitrakvi Due to Mold Contamination

Germany-based Bayer (ETR: BAYN) has announced a voluntary recall of a specific lot of its tropomyosin receptor kinase (TRK) inhibitor Vitrakvi (larotrectinib) in the US market following the detection of contamination by the Penicillium brevicompactum mold in the oral solution. While no adverse events have been reported, Bayer has advised patients using this lot to discontinue its use immediately, citing potential risks for immunocompromised patients, who could be susceptible to life-threatening fungal infections of the blood or pneumonia.

Implications for Patients and Bayer’s Financial Performance

Vitrakvi is indicated for adult and pediatric patients with metastatic, unresectable, relapsing, or NTRK gene fusion-positive solid tumors in the US. This recall comes amidst a challenging period for Bayer, as reported by the recent release, which highlights a recent string of setbacks. The company’s kinase inhibitor Aliqopa (copanlisib) failed in a confirmatory trial, and Bayer has experienced unfavorable financial performance, with a decline in revenues of -3.2% year-on-year (YOY) between Q1 and Q3 2023.- Flcube.com

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