EMA committee backs approval of Bayer's Vitrakvi for people with solid tumours displaying NTRK gene fusion

Bayer announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approval of Vitrakvi (larotrectinib) for the treatment of adult and paediatric patients with solid tumours that display an NTRK gene fusion. The company noted that if authorised, the oral TRK inhibitor will be the first treatment to receive a tumour-agnostic indication in the EU.

Specifically, the CHMP backed approval of Vitrakvi in patients with solid tumours that have an NTRK gene fusion, are locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatment options. The drug was authorised in the US in November last year for patients with tumours harbouring an NTRK gene fusion, and is also cleared in Brazil and Canada.

Bayer noted that the CHMP's decision is based on pooled clinical data from 102 patients across Phase I and II studies. Results in the primary analysis population demonstrated an overall response rate of 72%, including a 16% complete response rate and a 55% partial response rate. Data also showed that 88% of patients were alive one year after the start of therapy, while median progression-free survival had not been reached at the time of analysis.

Scott Fields, head of oncology development at Bayer, remarked "as researchers learn more about tumour genomics, it becomes all the more important to ensure broad access to genomic testing to allow patients that have the potential to benefit from precision medicines to be identified and treated, moving us beyond a one-size fits all therapeutic approach."

Bayer obtained the exclusive licensing rights for the global development and commercialisation of Vitrakvi following Eli Lilly's acquisition of Loxo Oncology earlier this year. For related analysis, read Physician Views snap poll results: Are oncologists ready for the latest evolution in biomarker-driven cancer care?

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