Bayer announced Monday that the European Commission approved Vitrakvi (larotrectinib) for the treatment of adult and paediatric patients with solid tumours that display an NTRK gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options. The company noted that the oral TRK inhibitor is the first treatment in the EU to receive a tumour-agnostic indication.
Robert LaCaze, head of Bayer's oncology strategic business unit, said that approval of Vitrakvi "represents a meaningful advancement in the fight against cancer, as it treats the oncogenic driver that causes tumour spread and growth, rather than where the tumour originates in the body." The drug is already approved in the US, Brazil and Canada.
The EU approval, which follows a positive recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use in July, is based on pooled data from 102 patients. Results showed that in the primary analysis population, the overall response rate (ORR) was 72%, including 16% complete responses (CR) and 55% partial responses (PR). Meanwhile, in a further analysis including patients with primary central nervous system tumours, the ORR was 67%, including 15% CR and 51% PR.
In addition, data showed that 75% of responding patients had a duration of response of 12 months or longer, while one year after the start of therapy, 88% of patients from the primary analysis population were still alive. Bayer noted that eligible patients should be selected based on the presence of an NTRK gene fusion in their tumour. Earlier this year, the company entered a partnership with Foundation Medicine on the development of next-generation sequencing-based companion diagnostics for a number of cancer drugs, starting with Vitrakvi.
Bayer obtained exclusive licensing rights for the global development and commercialisation of Vitrakvi following the acquisition of Loxo Oncology by Eli Lilly in February.
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