Bayer’s Vitrakvi becomes first tumour-agnostic therapy approved by NICE for NHS patients with NTRK fusion+ cancer

pharmafile | April 21, 2020 | News story | Manufacturing and Production, Sales and Marketing Bayer, Cancer, NICE, UK, Vitrakvi, tumour agnostic 

Bayer’s oral TRK inhibitor Vitrakvi (larotrectinib) has just been recommended by NICE in the treatment of advanced neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumours.

The decision covers adult and paediatric patients on the NHS in England and Wales who have locally advanced or metastatic tumours, have no satisfactory treatment options, or in whom surgery is not an option.  

The decision marks availability of the first tumour-agnostic treatment for NHS patients in England, a class of therapy which is able to treat solid tumours with an NTRK gene fusion regardless of where they first originated in the body.

Data drawn from a pooled analysis of 102 adult, adolescent and paediatric patients across three Phase 1, 1/2 and 2 trials, which included nine patients with primary CNS tumours, revealed that Vitrakvi demonstrated a 67% overall response rate (ORR). When these CNS tumour patients were excluded, the drug showed an ORR of 72% in the same group.

Furthermore, the therapy also recorded a median time of 1.81 months until patients achieved first response, but median overall survival had not been reached by the time of analysis. It was also reported that, in two global trials, 60% of patients receiving Vitrakvi saw an improvement in quality of life in terms of in EORTC QLQ-C30 global health scores.

“Bayer welcomes NICE’s recommendation for larotrectinib as it will allow clinicians, for the first time in England, the opportunity to offer adult and paediatric patients with TRK fusion driven cancer a therapy that targets the specific driver of their disease,” said Amanda Cunnington, Head of Patient Access at Bayer UK.

She added: “The health service and our society are facing considerable challenges with the coronavirus pandemic.  Whilst NICE is rightly focusing its efforts on rapid COVID-19 guidelines, we welcome the recommendation being communicated so that eligible patients can access this oral treatment without delay.”

Matt Fellows

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