Source: Prism (ID: lengjing_qqfinance), Wall Street reporter
Edit | Yang Wei
Treatment for infrequent tumor types has recently been approved by the United States Food and Drug Administration (FDA) and has been interpreted as having a 75% healing rate for multiple cancers. It has caused great concern among people, but this is not the case.
The approved drug, called Larotrectinib (trade name Vitkravi), was developed jointly by the "Loxo Tumor" medical-precision medical company and the traditional "Bayer" pharmaceutical manufacturer. Bayer said the drug is the first anti-tumor chemical approved by the US Food and Drug Administration to "not distinguish between types of tumors."
The Food and Drug Administration of the United States has said that the last approved drugs will inhibit the abnormal fusion of the NTRK gene with other genes: a fusion that has been considered as a growth indicator that supports the development of the tumor. The fusion of NTRK is not common, and it usually occurs in cancerous parts of the body, including lung cancer and thyroid cancer.
The healing rate of 75% is not understood
According to Bayer, the overall response rate (ORR, translation response rate) was 75% among adults and children involved in the experiment, including 22% of total remission and 53% partial relief . The so-called remission rate refers to the proportion of people who have decreased or disappeared after the patient receives treatment, and does not refer to the healing ratio.
According to the experimental data, a total of 55 patients participated in the three experiments. The Food and Drug Administration of the United States said that the experimental response was sustainable: based on the analysis of experimental results, 73% of the relief lasted for at least six months and the 39% of the relief lasted at least one year. Approved drugs are effective for soft tissue sarcoma, salivary gland cancer, childhood fibrosarcoma, thyroid cancer, and lung cancer.
Although new approved drugs can treat a variety of cancers, known as "broad spectrum anticancer drugs," they are only effective for some patients with certain genetic features. Therefore, the US Food and Drug Administration also gives you the "qualification of orphan drugs", in accordance with the relevant legislation, orphan drugs can obtain practical conditions such as rapid approval, the reduction of taxes, the exemption of the rates of reports, subsidies of research and development, etc. Attend and promote the development of drugs to treat rare diseases.
Specifically, only those patients with "NTRK gene fusion in tumors" are eligible for treatment with this newly approved drug. According to Bayer, the relevant diagnosis can be diagnosed with next-generation sequencing technology (NGS) and in situ fluorescence hybridization (FISH).
In a press release, Bayer quoted Robert LaCaze, head of his oncology strategy business unit, saying: "Fusion of NTRK is scarce, but it exists in many different types of tumors. … for those with NTRK gene fusion. It is very significant to provide a specialized treatment plan for patients with advanced solid tumors. "
According to Bayer, the Food and Drug Administration of the United States "approves the overall response rate and the duration of remission based on the drug for the treatment of the tumor" and approves for " patients with solid adult and child tumors "according to an accelerated procedure. He also stated that "subsequent approval may depend on the validation and description of clinical benefits in a confirmatory trial."
US Commissioner Scott Gottlieb of the Food and Drug Administration said the approval of the new drug reflects the progress of biomarkers in the drug development guide and in the # 39 ; more precise use of drugs.
High price, difficult to sell
Loxo Tumors and Bayer reached an exclusive cooperation agreement in November 2017 to develop two drugs: Larotrectinib and the next-generation TRK inhibitor LOXO-195.
Regarding the division of labor, Loxo tumors will lead future clinical studies and regulation problems in the United States, while Bayer dominates regulatory problems outside of the United States and global commercial activities. In the United States, both parties will jointly promote market promotion activities.
This is not an economic economic partnership: if the cooperation works well, Bayer will pay a total of $ 1.55 billion to Loxo Cancer.
According to this agreement, Bayer will pay an advance payment of $ 400 million to the tumor of Loxo, when Larotrectinib obtains regulatory approvals in an important market and completes the first commercial sale, the latter will receive another $ 450 million. When the LOXO-195 completes the same steps, it will receive another 200 million dollars.
As for expenses, the two companies will share R & D expenses in the United States, both will share the business expenses and match the benefits. On the North American market, Bayer will pay $ 25 million when net sales reach a certain threshold; In the United States outside of the United States, the two companies will use a gradual approach to sales by layers and Loxo tumors will receive up to $ 475 million. .
Reuters quoted the analyst of the BTIG financial company, Dane Leone, in stating that Larotrectinib's annual sales will reach its maximum in 2026, at $ 1,500 million. The Financial Times quoted Citigroup's analysis stating that annual drug sales will reach the maximum in 2030, or about $ 1.9 billion.
The approved drug is expensive and Forbes quoted Bayer that, according to adult capsules, the price of 100 mg capsules per day for 30 days is $ 32,800. The dosage form for adults or children is $ 11,000 per month.
Previously, some analysts believe that both companies will face marketing difficulties. On the one hand, the proportion of patients with the disease is limited in patients with cancer, and doctor Yu, a botanic doctor at the University of Beijing, mentions in a popular science article about cancer that only 0, 21% of the approximately 11,000 patients with cancer belong to the TRK fusion cancer. On the other hand, the related detection techniques are currently not popular, and it is not difficult to detect the corresponding patients.
Enter the process of approval of the Chinese market or accelerate
When Larotrectinib was launched in the United States, the United States Drug and Food Administration selected procedures such as Priority Review, Breakthrough Therapy and Accelerated Approval. In fact, the agency also widely spread the drug approval process as a model to improve its efficiency.
Previously, the new US government undertook to further simplify the supervision of the Drug and Food Administration. The new Director of Food and Drug Administration, Gottlieb, publicly stated that accelerating the approval of medications, supporting the promotion of prescription drugs and relaxing the supervision of generic drugs. This is proof that Larotrectinib was approved.
The prudent procedure of the US Food and Drug Administration on the approval of drugs has been criticized for a long time. Critics say long-term review delayed the treatment of the patient and, on the other hand, affects the commercial arrangement of the drug factory and increases the costs. In response, the agency tried to simplify and relax the regulation.
Drugs that receive priority approval often "significantly improve the safety, effectiveness and effectiveness of treatment, diagnosis or prevention of serious conditions" compared to medications that follow the standard review process. The approval period was reduced from 10 months to 6 months.
Eligibility for advanced therapy can be applied when the drug that is being developed will be used to treat a serious condition and the initial clinical outcome indicates that it has a "substantial improvement" in # 39 ; extreme "clinically significant".
In the accelerated approval process, monitoring of foods and drugs may use the final point of substitution or the intermediate endpoint to pass the drug. In other words, when these indicators can predict that the drug is likely to have efficacy or clinical benefit, conditional approval of the drug in the market.
According to Bayer, patients will provide oral capsules and solutions to the American market. In addition, the company has sent a registration request to the European Medicines Agency in August. With regard to the agreements for inclusion in China, Bayer only said that it will continue to fulfill its commitment to introduce more innovative and more important products.
People in the industry told Tencent "Pixel" that if Bayer really intends to introduce related products in China, it expects that "the approval time will not be very long." The reason is that Chinese drug regulatory agencies also try to improve the effectiveness of drug approval.
This is illustrated by the process of approval of the monoclonal antibody "Anti-cancer of the wide spectrum." The cancer medication produced by Merck appears in China in July 2018 and the approval process took less than half a year. In a press release, Merck cited the words of his Chinese president, Luo Wanli, and strongly praised the practice of Chinese regulators actively by introducing innovative medications and increasing the speed of the approval of new drugs.
Improving workflow is one of the measures. Previously, the accounting firm, Deloitte, said in a report that, for innovative medications, the "strict entry" attitude of the Chinese government allowed for the approval of clinical trial applications It was longer than other markets, such as the USA.
In addition, local governments are also working hard. The Shanghai municipal government announced on July 10 that the action plan of 100 expansion plans mentioned "to fight for the urgent need for clinically available anti-tumor drugs that had been listed in the # 39; foreigner and have not been approved for registration in China and are using in Shanghai. " .
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The original title "Decrypt" of broad spectrum of drugs against cancer: the healing rate of 75% is poorly written, applicable to less expensive and difficult to sell | Prism
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