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Basic Information About Larotrectinib (Vitrakvi) .pdf

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Huateng Pharma


Basic Information About Larotrectinib (Vitrakvi)
Larotrectinib (tradename Vitrakvi) is a drug which used for the treatment of
cancer. It is an inhibitor of tropomyosin kinase receptors TrkA, TrkB,
and TrkC. Larotrectinib was initially granted orphan drug status in 2015 for soft
tissue sarcoma, and breakthrough therapy designation in 2016 for the
treatment of metastatic solid tumors with NTRK fusion. Some clinical trial
results were announced in 2017. On 26 November 2018, FDA approved
Larotrectinib for cancers with certain genetic trait. In September
2019, Larotrectinib was officially approved for use in European countries.

What is Larotrectinib?
Larotrectinib is a TRK inhibitor that works against cancers anywhere in the body
with NTRK gene fusions. It is the first cancer drug which to be designed from the
start to fight a specific genetic mutation, not a traditional cancer type. It is not
approved to fight breast cancer or lung cancer or colon cancer. Instead, it’s
designed and approved to treat cancers that arise anywhere in the body that
carry a certain genetic characteristic.

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How Larotrectinib works?
Larotrectinib is a targeted therapy that targets and binds to tropomycin receptor
kinase (TRK) proteins found on the surface of the cell. Tumor cells may
overexpress TRK proteins or develop constantly active TRK proteins. By binding
to these proteins larotrectinib blocks an important pathway that promotes
tumor cell division and survival. It disrupts the activity of TRK proteins caused
by mutations in the NTRK gene family, called fusions. Larotrectinib treatment
shrank tumors in many patients whose tumor cells overexpressed the TRK
fusion proteins.

Larotrectinib's performance in multiple clinical trials
1. In February 2018, the New England Journal of Medicine (NEJM) published the
results of three clinical studies on safety and efficacy, showing an overall
response rate of 75% for 17 different cancer treatments for patients aged 4
months to 76 years.

Image: Loxo Oncology

2. The latest data released at ESMO's annual meeting in October 2018, showed

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that Larotrectinib was able to achieve an 80% objective response rate (ORR) in
55 patients with TRK fused cancer measured by RECIST.

What's the highlights of Larotrectinib?
First, no limit to the types of cancer. It means that 17 cancer types, including
breast, colorectal, lung and thyroid cancers, are available for both adults and
children as long as NTRK fusion is present.
Second, the overall response rate is as high as 75%. Pooled data from three
large clinical trials in TRK patients with fused cancer showed an overall response
rate of up to 75% ORR for Larotrectinib, with 22% of patients achieving
complete response.
Third, fast and lasting response. Larotrectinib works very quickly, and when it
does, the relief it brings is often unexpected. The average onset time was only
1.84 months, and 73% of patients responded for more than 6 months, the data

What are the






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Larotrectinib appeared to be largely safe, with little evidence thus far from the
trials that it causes any serious side effects. The most common side effects of
the drug included fatigue, nausea, cough, constipation, diarrhea, dizziness, and
vomiting. Pregnant or breastfeeding women should not take Vitrakvi, which
may be harmful for a developing fetus or newborn baby.
Huateng Pharma, a leading pharmaceutical company focusing on R&D of
pharmaceutical intermediates. We have extensive experience in the
development of new anti-cancer drugs intermediates such as Carfilzomib
intermediates, Palbociclib intermediates, Ribociclib intermediates, Elagolix
intermediates and so on. We can also provide Larotrectinib intermediates CAS
No.1919868-77-1, CAS No. 1218935-60-4, CAS No. 1363380-51-1 and CAS
No. 100243-39-8.

[1] FDA approves Vitrakvi for cancers with certain genetic trait
[2] FDA approves a new cancer drug targeted to genetic mutation, not cancer type

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