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Bayer BAYRY announced that the FDA has granted full approval to oncology drug, Vitrakvi (larotrectinib), a first-in-class TRK inhibitor.
The drug is now fully approved in the United States for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation that has spread or for those who are not eligible for surgery. The drug was approved for patients who did not have any satisfactory alternative treatment or whose disease progressed following treatment.
Please note that Vitrakvi was first granted accelerated approval by the FDA in November 2018.
More on BAYRY's Vitrakvi
The full FDA approval was based on the results of confirmatory trials that support Vitrakvi as a potential new standard of care treatment option for NTRK gene fusion-positive tumors in adult and pediatric patients.
Vitrakvi, a first-in-class oral TRK inhibitor, was exclusively designed to inhibit against the TRK family of proteins (TRKA, TRKB and TRKC).
Pooled efficacy results from three multicenter, open-label, single-arm clinical trials — LOXO-TRK-14001 (NCT02122913), SCOUT (NCT02637687), and NAVIGATE (NCT02576431) — showed an overall response rate of 60% with a complete response rate of 24% and a partial response rate of 36%.
Bayer obtained the exclusive licensing rights for the global development and commercialization of Vitrakvi following the acquisition of Loxo Oncology by Eli Lilly and Company in February 2019.
Bayer Looks to Solidify Portfolio
2025 is likely to be another challenging year for this German pharma giant as it expects earnings to decline and sales to grow modestly. The uncertainty caused by ongoing Roundup litigation is also a major hangover on the stock.
Sales growth was encouraging in the Pharmaceutical division in 2024. New products, Nubeqa and Kerendia, retained their impressive momentum and offset the negative impact of a decline in Xarelto sales. The company is working to expand the labels of its key drugs, Nubeqa and Kerendia, which should boost growth.
Successful development of additional drugs is imperative for Bayer amid multiple challenges. BAYRY expects to launch two new drugs — elinzanetant, a hormone-free treatment for menopause symptoms, and acoramidis, a drug for the treatment of a certain type of heart disease.
Shares of BAYRY have surged 15.4% year to date against the industry’s decline of 8.2%.
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The company also aims to strengthen its pharmaceutical pipeline. In 2021, Bayer acquired clinical-stage biopharmaceutical company Vividion Therapeutics to expand into precision small-molecule therapeutics, primarily in oncology and immunology.