Source: Prism (ID: lengjing_qqfinance), Wall Street Journalist
Edit | Yang Wei
The treatment of rare types of tumors has been approved by the US Food and Drug Administration (FDA) and has been a 75% healing rate for multiple cancers. He has created a lot of concern among people. However, this is not the case.
The approved drug, the brand name Larotrectinib (Vitkravi commercial name), the exact medical company "Loxo Tumor" and the traditional manufacturer of "Bayer", were jointly developed. Bayer said the drug is the first chemical tumor approved by the US Food and Drug Administration that "there is no distinction between some type of tumor".
According to the U.S. Food and Drug Administration, the final drug approved with other genes will inhibit the abnormal fusion of the NTRK gene, a fusion seen as a sign of growth that supports tumor development. NTRK melting is not common, and it usually occurs only in the body's cancerous parts, including lung cancer and thyroid cancer.
75% cure rate is misunderstood
According to Bayer, the overall rate of response (ORR, translation response rate) was 75% among adults and children involved in the experiment, including 22% remission and 53%. Partial relief The so-called Reference Rate refers to the proportion of people who have diminished or disappeared from their treatment when they receive treatment, and does not mention any cure.
According to experimental data, 55 patients participated in three experiments. The US Food and Drug Administration said the experimental response was permanent: from the analysis of experimental results, half of 65% lasted for at least six months, and 36% lasted for at least one year. Supported drugs are effective in soft tissue sarcoma, salivary gland cancer, fibrosarcoma infant, thyroid cancer, and lung cancer.
Although accepting new medications to treat certain types of cancers, known as "broad spectrum medications", they are only effective for a few patients with certain genetic features. For this reason, United States Food and Drug Administrations provide "an orphan drug title" – according to the applicable legislation, orphans may obtain the necessary conditions, such as rapid admissions, tax restrictions, exemption from fees, research and development subsidies, etc. Strengthening and promoting drug development for rare diseases.
Specifically, patients with "NTRK gene fusing in tumors" have the right to treat them with a new drug-approved drug. According to Bayer, the next diagnosis of the next generation technology (NGS) and fluorescence in situ hybridization (FISH) can be diagnosed.
In a press release, Bayer undertook Robert LaCaze, his oncology strategy business unit, to say, "NTRK fusion is rare, but there are many types of tumors … NTRK gene fusion is very important for providing a special treatment plan for patients with advanced solid tumors ".
Bayer says "The United States Food and Drug Administration" accepts the rate of response based on the treatment of the tumor and the overall duration of its duration and accepts it for "adult and child-friendly tumor patients" according to the rapid procedure. He also stated that "subsequent approval may depend on the validation and description of clinical benefits in an assertion test".
The US Food and Drug Administration, Scott Gottlieb, said the new drug approval recognizes the advancement of biomarkers as a drug development guide and a more accurate drug.
High price, difficult sale
Loxo Tumors and Bayer obtained an exclusive collaboration agreement in November 2017 for the development of two drugs: Larotrectinib and next-generation TRK cancer inhibitor LOXO-195.
Loxo tumors will monitor the next clinical research and regulatory issues in the United States, and Bayer controls external regulatory issues outside the United States. In the United States, both parties will promote market promotion.
This is not a cheap business cooperation: if cooperation is successful, Bayer will pay $ 1,550 million for Loxo Cancer.
According to the debtor, Bayer will pay $ 400 million over the Loxo tumor, which Larotrectinib obtains approved homologation in a particular market, and when it first carries out sales, the latter will receive another $ 450 million. When the same steps of LOXO-195 are met, another $ 200 million will be received.
In terms of expense, both companies will share R & D expenses in the United States to share both business expenses and equalize profits. In the US market, Bayer will pay $ 25 million when the net sale reaches a certain section; In the United States outside the US, both companies will use layers of sales layers and Loxo tumors will be $ 475 million. .
Reuters said BTIG analyst Dane Leone's finance company said Larotrectinib's annual sales will cost $ 1,500 million in 2026. The Financial Times mentioned Citigroup's analysis that drug sales would be around 2030 or about $ 1.9 million.
The newly approved drug is expensive, and Forbes says Bayer, as an adult capsule says, 30-day capsules of 100 mg per day are $ 32,800. The dose-form for adults or children is $ 11,000 per month.
Previously, some analysts believe that both companies have difficulties in marketing. On the one hand, the proportion of patients with illness is limited to cancer patients. Yu, a botanic doctor at Peking University, has been referring to a cancer science article, 11,000 only 11.1% of cancer patients are TRK fusion cancer. On the other hand, the related detection techniques are not known at present, and it is not difficult to reveal the corresponding patients.
Introduce or accelerate the Chinese market approval process
When Larotrectinib was launched in the United States, the US Food and Drug Administration selected priority trials, advanced therapy, and approved approval procedures. In fact, agencies have expanded the process of drug approval as a model for improving efficiency.
Further, the new United States government wants to facilitate the supervision of food and drug administration. According to the new director of Gottlieb Food and Drug Administration, it is necessary to accelerate drug acceptance, to promote drug abuse and to reassure the general drug reassurance. It is proof by Larotrectinib.
He has been criticized for a long time with the responsible procedure for Food and Drug Administration in the United States. Critics say long-term reviews delay the treatment of the patient and, on the other hand, causes drug trading in the factory and increases costs. As a response, the body wanted to simplify and relax regulation.
Medications that receive priority recognition often "significantly improve the prevention, safety, efficiency and effectiveness of treatment, diagnosis or serious conditions," according to the Standard Review process. Approval was shortened from 10 months to 6 months.
The acceptance of therapeutic resources may be applied when the treatment is being used to develop a serious drug condition and the clinical outcome indicates a "significant improvement" at the end of the "clinically significant" period.
In accelerated admission process, food and pharmacy supervision may use the end point of replacement or intermediate point to accept medication. In other words, those who allow foreseeable indicators predict drug efficacy or clinical benefit if they market drugs.
Bayer has provided patients with oral capsules and solutions to the US market, and in August it has presented a list of the European Pharmacy Agency. With regards to listing listing in China, Bayer only states that it will be committed to establishing more innovative and important products.
Industry people have "Pixel" Tencent told Bayer that if he wants to introduce real-world products in China, it is expected that "the time of admission will not be too long." The reason is that Chinese drug regulatory agencies are also trying to improve the effectiveness of drug approval.
This is illustrated by the process of admission to the monoclonal Pabolim antigensus "Great Anti-Cure Process". Merck's anti-cancer cancer is listed in China in July 2018, and the admission process has taken less than half a year. In a press release, Merck says China's president says Luo Wanli and praised the Chinese regulatory practice by actively incorporating innovative drugs and increasing the speed of accepting new drugs.
Improvement of work flow is a measure. Previously, Deloitte's accounting published a report for innovative drugs, which the Chinese government's "sharp entry" attestation evidence accepted by clinical trials than other markets.
In addition, local governments are working hard. The Municipal Government of Shanghai announced on July 10 the "100 expansion plans" action plan "to find the urgent need for clinically available clinical tumors in the out-of-list list and not to sign in to China". .
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The original title "Decrypt" is a broad spectrum anti-drug drug: 75% healing rate is wrong, less expensive and difficult to sell Prism
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