A Cancer Drug Has Been Granted a New Drug Application by the FDA

Loxo Oncology has announced that the US Food and Drug Administration (FDA) has granted the drug larotrectinib Priority Review, and accepted a New Drug Application (NDA) for it.
These applications were accepted for the drug’s use as a treatment for adult and paediatric patients with metastatic or locally advanced solid tumours harbouring a gene fusion involving NTRK. NTRK gene fusions have been linked to several types of cancer. The full article can be read here, at Globe Newswire.

The FDA’s decision to grant larotrectinib Priority Review will mean that the drug review process is expedited for the FDA. They do this for experimental drugs that may significantly improve the treatment of serious conditions.

The FDA requires New Drug Application (NDA) acceptance before a drug can be commercialised. Evidence from clinical trials and other research into the drug is used to establish factors such as it’s safety, efficacy, and manufacturing process that are used to determine whether a NDA should be accepted.

In addition to these two statuses, larotrectinib has previously been granted Orphan Drug, Rare Paediatric Disease, and Breakthrough Therapy designations by the FDA.

The new designations are for its treatment of patients with locally advanced or metastatic (spread to other areas of the body) solid tumours harbouring an NTRK gene fusion. NTRK stands for neurotrophic tyrosine receptor kinase. Researchers have discovered that NTRK genes are involved in cancer. NTRK genes fusing to other genes can produce growth signals that are implicated in a wide range of both adult and paediatric cancers. These include breast cancer, appendiceal cancer, cholangiocarcinoma, lung cancer, GIST, infantile fibrosarcoma, pancreatic cancer, thyroid cancer, melanoma, and some sarcomas, amongst others. In some of the rare cancers, such as secretory breast, infantile fibrosarcoma, and secretory salivary gland, the proportion of patients affected by NTRK gene fusions is thought to be high (possibly over 60%).

Larotrectinib has been shown to have an anti-tumour effect in tumours with NTRK gene fusions. The research indicates that this is true for patients of all ages and tumour types.
Larotrectinib is being developed and commercialised by a collaboration of two companies, Loxo Oncology and Bayer. They are planning to submit a Marketing Authorisation Application in the European Union later this year.

Anna Hewitt

Anna Hewitt

Anna is from England and recently finished her undergraduate degree. She has an interest in medicine and enjoys writing. In her spare time she likes to cook, hike, and hang out with cats.

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