Li Yong’s beloved wife, Harvin, posted on Weibo last August:

"AIDS vaccines are available, are cancer vaccines still far away?"

However, a full month after Li Yong left

Finally, just yesterday

A precise anti-cancer drug, officially listed in the US FDA!

Target 17 tumors

The effective rate can be as high as 75%!

This is the first TRK inhibitory drug ever

first setNo relation to tumor typeOf"Broad Spectrum" Anticancer Drugs

forUnresectable tumor,orLate patients who have metastasizedWonderful

This is undoubtedly the most exciting blockbuster news

Another great creation and legend in the history of human medicine!

Time to market in the US:2018/11/26

authority:U.S. Food and Drug Administration (FDA)

Drug name:Vitrakvi (aka Larotrectinib)

Drug efficacy:Effective against various cancers driven by a single rare gene mutation

Target groups:Adult and pediatric patients with solid tumors

manufacturer:Co-developed by Bayer and Loxo Oncology

1. When will it be listed?

Yesterday, November 11th, US time,The anti-cancer drug Vitrakvi has been officially launched in the United States.

Bayer and Loxo Oncology jointly announced that the FDA has accelerated its time to market.

Vitrakvi becameThe first oral TRK inhibitor officially approved for marketing, And also the firstNo relation to tumor type(Tumor-agnostic)"Broad Spectrum" Anticancer Drugs.

The domestic market time has not yet been announced. However, imported biological agents usually take months to several years for approval.

2. Adapt to age?

Suitable for infants to elderly people.

3. What can be treated?

Types of effective treatment:

Lung cancer, thyroid cancer, melanoma

Gastrointestinal cancer, colon cancer, soft tissue sarcoma

Salivary glands, infant fibrosarcoma, appendix cancer

17 types of breast cancer, bile duct cancer, pancreatic cancer, etc.

Vitrakvi is used to treat adults and children carrying NTRK gene fusion ((gene fusion)),Patients with locally advanced or metastatic solid tumorsAnd did not produce known resistance mutations,Metastatic or surgical resection may cause severe morbidity, and there is no effective alternative treatment.

LOXO-101 is a targeted drug targeted at tumor patients with NTRK1, NTRK2 or NTRK3 gene fusion.

Simply speaking, this new drugNo need to consider where the cancer occursThis means that no matter what kind of cancer (tissue/cell/site), as long as there is NTRK gene fusion, Vitrakvi can be used for treatment.

So, cancer patients can go for genetic testing,Be sure to check the test report for this gene fusion. If there is,Then it is very likely to be cured by the drug!

(Source FDA official website)

4. How long will it take effect?

根据FDA公布数据显示,73%的患者反应时间为6个月以上,63%的患者反应时间为9个月以上,39%的患者反应时间为12个月以上。

US FDA: "Precise anti-cancer, the effective rate is as high as 75%"!

How amazing is the effect?

2018 years 2 months,Four authoritative medical journals in the worldOne of the results of a clinical study on the safety and effectiveness of the anticancer drug Vitrakvi (also known as larotrectinib) published by the New England Journal of Medicine (NEJM) showed:

For patients aged 4 months to 76 years, the overall effective rate for 17 different cancer treatments is 75%.

This result was subsequently confirmed by the FDA.

(Source: "New England Journal of Medicine")

Immediately afterwards, at the European Society for Oncology Conference (ESMO2018) held in October 10, a clinical data on the treatment of the anticancer drug Vitrakvi covering 2018 unique tumor types with TRK fusion cancer in adults and children showed that:

Overall response rate: 80%

Partial response rate: 62%

Complete remission rate: 18%

The exciting data doesn't stop there!

The following are some of the latest cases of clinical treatment with the anticancer drug Vitrakvi:

Gastrointestinal stromal tumor:

55 years old male

Before treatment:Cancer cells have almost spread to the entire stomach and abdominal cavity

After treatment:After receiving 9 cycles of treatment, a miracle appeared, the tumor was significantly reduced, and he is currently receiving the 10th cycle of treatment.

Fibrosarcoma in children:

16 month old baby

Before treatment:After genetic testing, the mutation of ETV6-NTRK3 was found. After 3 operations and chemotherapy, the effect was still not obvious.

After treatment:acceptAnticancer drug VitrakviAfter 3 cycles of adult-dose liquid preparations, MRI showed a 90% reduction in tumor volume!

Breast cancer:

50 year old female

Before treatment:This patient had received many chemotherapy and surgical treatments before, but finally the tumor recurred and the condition was very serious.

After treatment:usedAnticancer drug VitrakviAfter 20 days of treatment, the exposed tumor almost disappeared.

Undifferentiated sarcoma

41 year old female

Before treatment:The patient’s tumor cells have spread to the lungs and will soon fill the lungs.

After treatment:Quickly resolve dyspnea and hypoxemia. After 2 cycles, most of the tumor disappeared, after 12 cycles, the tumor tissue almost completely disappeared!

After clinical trials, taking this medicine will also have someSide effectsThe common ones are fatigue, nausea, dizziness, anemia, coughing, vomiting, diarrhea, etc.

Like all drugs, this magic drug will faceResistanceThe problem. However, it is reported that Loxo has developed the second-generation TRK fusion gene mutation inhibitor LOXO-195 for the treatment of patients who have developed resistance to this drug.

How much is the price, can it be used?

Last night Loxo Oncology also announced the price of this new drug:

Adult capsule wholesale purchase cost:32,800 dollars,30 days usage

Cost of oral liquid formula for children: starting at $11,000 per month,Calculated based on the patient's surface area

The high price has also aroused suspicion from patients' families.

At present, Bayer says that patients will not be unable to afford it. Most patients’The monthly out-of-pocket expenses will be $20 or less.

Their company will help patients pay expensive fees and willFree Vitrakvi, at the same time formulate insurance details. If the patient cannot afford the drug, a charity funded by Bayer will provide the drug free of charge. Bayer also promises that if the patient is being treatedNo clinical results in the first 3 months,willRefund all expenses of payers such as insurance companies or individuals.

(Source: "Forbes")

Why can many different types of tumors be treated?

This medicine is everThe first TRK inhibitory drug.

TRK, yesTropomyosin receptor kinase (tropomyosin receptor kinase) is an important signaling pathway that regulates cell communication and tumor growth, and NTRK is a gene encoding TRK. In rare cases, NTRK gene will be fused with other genes,The TRK signaling pathway is not controlled, thus promoting tumor growth.

Although these tumors come from different sources and appear to be very different on the surface, they are actually very similar from a molecular biology point of view because they have one common feature:Carry TRK fusion gene mutation, And rely on this mutant gene to provide growth signals.
Because they all rely on the TRK gene in nature, they all respond positively to TRK-targeted drugs.

How many people will get new hope?

According to statistics, in the United States, approximately2000 to 3000 peopleSuffered from NTRK-related cancer.

This mutation occurs in less than 1% of most solid tumor types, but it is common in malignant tumors such as adult salivary gland cancer and infant fibrosarcoma.

At present, cancer has become the biggest nemesis of mankind!

The International Agency for Research on Cancer (IARC) under the World Health Organization released the latest global cancer statistics in 12, the Global Cancer Report:

In 2018, there were 1810 million new cancer cases worldwide and 960 million deaths.

At the same time, the "Report on the Development of Chinese Malignant Tumor Discipline (2017)" shows:

About 1 people are diagnosed with cancer every day in China,About 7 people are diagnosed with cancer every minuteAfter the age of 40, the incidence of cancer rapidly increases, reaching a peak at the age of 80. After the age of 85, a person’s cumulative risk of cancer is 35%.

Another data shows that the overall 5-year cancer survival rate in the United States is 66%, while the overall cancer survival rate in China is 31%, less than half of the United States.

Scott Gottlieb, Director of the US FDA, said:

"The official launch of the anti-cancer drug Vitrakvi marks an important step in the transformation of cancer treatment from tissues of human origin to genetic characteristics of tumors!"

It is hoped that this drug can be launched in China as soon as possible, saving more lives and benefiting more families.

I hope that more cancer patients can get matched and effective drugs at the right time.

If one day, with the advancement of science, all types of cancer could be cured, how great it would be!

For more details, please check the US FDA official website:

https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm626720.htm

REF:

https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm626720.htm

https://www.seattletimes.com/seattle-news/health/fda-approves-precision-medicine-drug-for-different-cancers-with-same-mutation/