FDA approves drug for cancers with specific biomarker Posted 14/12/2018

The US Food and Drug Administration (FDA) announced on 26 November 2018 that it had approved Vitrakvi (larotrectinib), a treatment for adult and paediatric patients whose cancers have a specific genetic feature (biomarker).

Vitrakvi (larotrectinib) was granted accelerated approval by FDA. It marks the second time that the agency has approved a cancer drug based on a common biomarker across different types of tumours rather than the location in the body where the tumour originated.

The drug is indicated for treatment of adult and paediatric patients with solid tumours that have a neurotrophic receptor tyrosine kinase (NRTK) gene fusion.

The approval was based on studies of the efficacy of the drug in three clinical trials involving 55 paediatric and adult patients with solid tumours with NRTK gene fusion. Vitrakvi demonstrated a 75% overall response rate across different types of solid tumours, with 73% of responses lasting at least six months and 39% lasting a year or more.

The approval, according to FDA Commissioner Scott Gottlieb, ‘marks a new paradigm in the development of cancer drugs that are “tissue agnostic”’. He added that the approval ‘follows the policies that the FDA developed in a guidance document released earlier this year’ (Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease Oct 2018).

FDA Commissioner Scott Gottlieb added that through FDA’s breakthrough therapy designation and accelerated approval processes, the agency is supporting ‘innovation in precision oncology drug development and the evolution of more targeted and effective treatments for cancer patients’.

Related articles
FDA approves more generics in 2018 than any other year

FDA proposes standardization of generics standards

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2018 Pro Pharma Communications International. All Rights Reserved.

Source: US FDA

Comments (0)