- LOGIN
- MemberShip
- 2026-05-20 05:10:45
- Company
- General hospitals to prescribe Jeil Pharmaceutical Lonsurf
- by Eo, Yun-Ho Jul 10, 2020 06:13am
- Major general hospitals in Korea are readying prescription of Jeil Pharmaceutical’s Lonsurf indicated to treat patients with colorectal cancer. According to pharmaceutical industry sources, Lonsurf (tipiracil/ trifluridine) has been passed by drug committees (DCs) at the Big Five—Seoul National University Hospital, Samsung Medical Center, Seoul Asan Medical Center and Severance Hospital. Jeil Pharmaceutical won the sales license in Korean market over Lonsurf from Japan-based Taiho Pharmaceutical. The drug is indicated to treat patients with metastatic colorectal cancer previously treated with fluoropyrimidine‑, oxaliplatin‑ and irinotecan‑based chemotherapy, an anti‑vascular endothelial growth factor (VEGF) biological therapy, and an anti‑epidermal growth factor receptor EGFR therapy (if confirmed as RAS wild type). It was approved for Korean market in October last year. The drug uses tipiracil to inhibit thymidine kinase that breaks down trifluridine to maintain the blood concentration. A clinical study confirmed Lonsurf’s statistically meaningful improvement in overall survival (OS) against the best supportive care and the treatment meeting the primary clinical endpoints. The drug’s safety was also confirmed in another clinical study conducted previously. As of 2016, according to Korea Central Cancer Registry (KCCR) report, the number of patients diagnosed with colorectal cancer in Korea reached 28,127, coming second after stomach cancer. And the demand for drugs to be used in patients, who do not respond to standard of care, is rising. Specifically, Lonsurf is taking the limelight as a new treatment option that meets the demand. Lonsurf is approved in 75 countries and regions around the world including Korea as a treatment for metastatic colorectal cancer. In last year, the drug was also indicated to treat metastatic stomach cancer in the U.S., Japan and Europe. The drug globally generates approximately USD 30 million. The U.S. National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) guidelines respectively recommend Lonsurf as ‘Category 2A’ and ‘Level 1/ Grade B’ to patients with metastatic colorectal cancer who have failed to respond to standard of care.
- Company
- 66 companies complain choline alfoscerate coverage reduction
- by Jul 10, 2020 06:13am
- A group of pharmaceutical companies filed a complaint against the government’s decision to reduce coverage on choline alfoscerate drugs. Choline alfoscerate drugs in Korea On July 8, 66 pharmaceutical companies with choline alfoscerate issued a joint statement about their complaint filed for Korea’s Health Insurance Review and Assessment Service (HIRA) to reassess the reimbursement adequacy. The companies reprimanded the decision contrasts against the government’s objective of adopting selective reimbursement system as the pharmaceutical expenditure among senior citizens would rise significantly, it does not properly reflect social demand on the drug, and they claimed the unreasonable decision goes against the order of executing clinical reevaluation first followed by reimbursement reevaluation. The 66 companies argued, “Steeply raising the patient copayment rate from 30 percent to 80 percent on some of choline alfoscerate’s indications (mild cognitive impairment and depression) completely contradicts the foundational goal of National Health Insurance coverage enhancement initiative that provides coverage on non-reimbursements (selective reimbursement system) to lower patient’s burden on medical expense and to improve medical accessibility.” The companies added, “While the global medical scene is still seeking for a proper dementia treatment, lowering the coverage rate on choline alfoscerate that delays the progression of dementia in order to save finance also contradicts the National Dementia Management Program.” The government's decision would leave no choice for the economically vulnerable senior citizens but to give up on using the drug. The companies also rebuked the decision does not properly reflect the social demands based on financial impact, medical importance, affected age group, and patient’s financial burden. To accommodate the social demand, the current special case in patient copayment imposes differentiated rate by categorizing depression as a mild case (copayment rate at 40 percent to 50 percent when prescribed in general hospital), and stroke as a severe disease (copayment rate at 5 percent). However the pharmaceutical companies states the new reevaluation on choline alfoscerate has fixed the copayment rate at 80 percent for all three indications—emotional and behavioral change, senile pseudo-depression, and secondary symptoms induced by mild cognitive impairment and stroke with risk of progressing into dementia. They also complained the order of reimbursement reevaluation was shuffled. The companies criticized, “Generally, drugs undergo reimbursement listing procedure after receiving an item approval, but choline alfoscerate had its reimbursement feasibility evaluation before re-verifying the safety and efficacy of the drug,” and “as a result, the affected pharmaceutical companies’ motivation to conduct the clinical reevaluation on choline alfoscerate has greatly diminished.” The 66 companies urged, “Choline alfoscerate has been prescribed for over two decades in Korea, and even the clinicians stress the reimbursement should be reevaluated based on the Ministry of Food and Drug Safety’s (MFDS) approval details.” On June 11, HIRA has decided to grant selective reimbursement on choline alfoscerate after reevaluating the drug’s reimbursement feasibility. A patient diagnosed with dementia taking choline alfoscerate drug to improve symptoms like cognitive impairment would maintain the copayment rate of 30 percent. But patient prescribed with the drug without the diagnosis would pay 80 percent of the pharmaceutical expense as copayment.
- Policy
- Safety verification data should be submitted for Metformin
- by Lee, Tak-Sun Jul 10, 2020 06:13am
- When applying for the approval of Metformin, a diabetes treatment drug for which carcinogenic substance NDMA has been detected, additional safety verification data should be submitted in the future. In particular, data that can prove that NDMA is not generated during the process should also be attached. According to the industry on the 8th, the Convergence Innovation Product Support Group of the MFDS recently prepared a 'Metformin Raw Material and Containment Authorization Management Plan', and provided information through associations. On May 26, the MFDS discontinued and recovered 31 items of Metformin in which NDMA, a carcinogenic substance, was detected excessively. It was instructed to submit process verification data demonstrating that NDMA is managed below the standard in the manufacturing process of the drug product by August 31st. The management plan prepared this time is about the permission, notification and registration (change) of raw materials and containing agents. According to the management plan, if new raw materials and containing agents are managed under NDMA management (maximum allowance of 96 ng per day), permission, notification and registration are processed. In addition, it is planned to check the evidence only for quality-related changes (raw drug and its quantity, manufacturing method, manufacturer, storage method, and usage period). Safety data includes 'process verification data' that can prove that NDMA is not generated during the process, and 'stability data' that has undergone long-term preservation tests. Specifically, the process verification data includes process variables that may affect NDMA production, NDMA generation potential review data due to the effect between Metformin and other components, storage conditions tests, and packaging and container reviews, In the future, NDMA occurrence in the manufacturing process or preventive/corrective measures that can be adjusted within the maximum allowable capacity per day, and NDMA detection variability between manufacturing lot numbers are considered. It also includes considerations for NDMA test results and test method validation data (when using its own test method), manufacturing process, process inspection, and standards. The stability data is based on the new drug, and the period of use is set by the long-term preservation test, but the period of use is set within 24 months based on the long-term preservation test for 12 months, the accelerated test for 6 months. NDMA detection list is added to the stability test, and in the case of the test method, validation data is exempted when using the test method by domestic and foreign regulatory agencies such as the MFDS. However, at least one actual production batch data should be submitted when selecting a stability test lot. The MFDS plans to supplement and submit safety proof data in connection with the process of complaint handling in the case of permits, reports, and changes to Metformin.
- Policy
- Government asks Gilead to import Remdesivir for 5,360 people
- by Lee, Jeong-Hwan Jul 10, 2020 06:13am
- While COVID-19 Pandemic was prolonged, it was found that the government limited the amount of Remdesivir, which was known to be effective in COVID-19 treatment, to 5,360 servings. The Central Disease Control Headquarters requested an emergency import of Remdesivir for 360 people and the pandemic preparation for 5,000 people. Kang Giyun, a member of United Future Party said on the 8th, "As a result of confirming the private internal documents of the KCDC, only requested the import of Remdesibir for 5,360 people." An antiviral drug, Remdesibir, was approved by the US FDA on May 1st for emergency use following the announcement that the recovery period for COVID-19 inpatients has been reduced by 31%. Currently, the United States has announced plans to secure 92% of Gilead's production of Remdesibir by the end of September. It means that countries around the world have jumped into the battle to secure the quantity of Remdesibir, and the competition has become fierce. Provided by Kang Ki-yoon In this situation, the KCDC asked Gilead Korea on the 3rd of last month to import Remdesibir for 5,360 people. According to data released by Kang Giyun, the KCDC officially sent Gilead a request of Remdesivir for urgent use (for 360 people) and the pandemic (for 5,000 people). Earlier, the KCDC received a portion of the free supply from Gilead in July and supplied Remdesivir to 29 domestic patients as of July 6th. Some of the quantities supplied by the KCDC in July have not been revealed, and the company plans to continue to purchase Remdesivir through price negotiations with the goal of importing 5,360 people from August. A member Kang said that the U.S. government is swearing that all Americans will get treatment whenever they want, and it is not possible to specify when the pandemic will end and when a domestic outbreak will occur. Also he added that it is necessary to properly check whether the amount of 5,360 servings is appropriate in terms of scale and secure sufficient treatment.
- Company
- No obligation to notify the originals of the split strategy
- by Kim, Jin-Gu Jul 09, 2020 06:27am
- In the patent dispute of Galvus (Vildagliptin),” a diabetes treatment for DPP-4 inhibitors that was recently completed, a blind spot in the licensed patent linkage system occurred. Generic company did not “notify” the original company of the fact that they applied for an item license in the process of challenging patents with a so-called “split indication” strategy. The original company claimed that it was in violation of the Pharmaceutical Affairs Law and the item license was invalid. In response, the MFDS, "It is not considered a violation of the Pharmaceutical Affairs Law." If there is another attempt to overcome the patent with the indication splitting strategy, it is still necessary to decide whether to notify according to the current regulations. ◆Controversy over the violation of the Pharmaceutical Affairs Law in the process of Hanmi's Galvus' patent dispute GalvusHanmi voluntarily withdrew its approval for Vildagle 50mg, generic for Galvus on the 6th. As a result, the patent dispute over Galvus was ended. 'Split indication', which received attention as a new patent overcoming strategy, lost its power. The controversy over the “violation of the Pharmaceutical Affairs Law” was raised in this dispute. The original company, Novartis, filed a claim that Hanmi was violating the Pharmaceutical Affairs Law because it did not notify them of the application for an item license in the process of challenging the patent. According to the licensed patent linkage system stipulated in he Pharmaceutical Affairs Law and the Patent Law, the generic company must notify the patent holder of the application for permission within 20 days from the filing date when applying for a license for a drug listed on the patent list. Hanmi Pharm said there was nothing wrong with it. It was argued that there was no obligation to notify, as the application for an item license was made to the extent that the patent rights were ineffective. Hanmi applied without excluding one of the five Galvus indications. It is a narrow interpretation of the effect of patent rights applied to Galvus. The reason was that Galvus patent is limited to 3 out of 1 to 5 indications. The MFDS has accepted the application. In January of this year, Vildagle was licensed. In April, insurance benefits were also registered. However, Hanmi did not release the product due to ongoing patent disputes. ◆How is the notification obligation required for registration? Novartis filed a lawsuit against the MFDS to revoke the license. It was alleged that the permission of the MFDS was also invalid, because the notice obligations prescribed by the licensed patent linkage system were not observed. As a result, the dispute ended with happening because Hanmi lost the patent trial and voluntarily withdrew the item license from Vildagle. If another generic company challenges the patent with a splitting strategy, it is unclear whether or not the original company should be notified of the application for an item license.. ◆The MFDS, "It is difficult to understand it as a violation of the Pharmaceutical Affairs Law" The MFDS said that there would be no problem without notifying the original company. An official from the MFDS said, “There is no change. It is not a violation of the Pharmaceutical Affairs Law if the scope of the application for item licensing is not related to the extended patent content." "It is legally dependent on what the permission is," he said. "It can be interpreted based on the contents of the extension of the patent office.” However, he said, “The patent judge interpreted the scope of the patent right as specified in Article 95 of the Patent Act as a trial decision. As Hanmi failed to avoid Galvus patents (with a splitting strategy), it is highly unlikely that other pharmaceutical companies will pursue the same strategy.”
- Company
- Amgen won the second trial of 'Enbrel' patent
- by Kim, Jin-Gu Jul 09, 2020 06:26am
- Samsung Bioepis, Benepali in Europe, and Eticovo in US Samsung Bioepis' Enbrel biosimilar 'Eticovo' (Etanercept) is expected to postpone the US debut. A patent lawsuit was conducted that could affect the Eticovo's early launch strategy, but the US court sided with the original company. According to the pharmaceutical industry on the 6th, the U.S. Federal Court of Appeals earlier this month has sided with the original company in a patent lawsuit between Enbrel's patentee, Immunex and biosimilar maker Sandoz. Immunex is a subsidiary of Amgen. This is the same result as the first trial made by the New Jersey District Court. The court respected the original trial that Sandoz company's failure to provide sufficient grounds to prove Amgen's patent invalidity. As a result, Amgen succeeded in maintaining and defending Enbrel's patent until 2029. However, the possibility of reversal remains. Immediately after the second trial was announced, Sandoz announced its intention to appeal the third trial. The reason that Sandoz and Amgen's litigation has attracted attention is that this ruling also affects Samsung Bioepis' Eticovo. Sandoz and Samsung Bioepis are actually in a patent dispute with Amgen. Enbrel biosimilar ‘Erelzi’ by Sandoz was approved by the U.S. Food and Drug Administration (FDA) in 2016. Eticovo by Samsung Bioepis was approved in April 2019. However, the two companies are unable to release products to the US market. They have the challenge of overcoming Amgen's patent. It is analyzed that Eticovo’s case is likely to follow the results of Erelzi’s case. It means that it is also determined whether Eticovo will be launched early according to the results of the patent lawsuit between Sandoz and Amgen, which will be judged by the US Supreme Court. Samsung Bioepis is actually watching the lawsuits between Sandoz and Amgen. It is said that there is no full-scale pleading after the lawsuit under the licensed patent linkage system began in April of last year. An official from Samsung Bioepis said, "We are watching the results of the lawsuit between Sandoz and Amgen." Samsung Bioepis currently has four biosimilars in the United States. Eticovo, Remicade biosimilar 'Renflexis', Humira biosimilar 'Hadlima', and Herceptin biosimilar 'Ontruzant', etc. Of these, Renflexis and Ontruzant are currently on sale. Eticovo & Hadlima have been postponed due to patent. However, Hadlima can be released after 2023 according to an agreement with the original company, AbbVie.
- Policy
- Hanmi loses out on patent trial, drops Vildagle approval
- by Lee, Tak-Sun Jul 09, 2020 06:26am
- Hanmi Pharmaceutical dropped the sales approval on antidiabetic dipeptidyl peptidase-4 (DDP-4) inhibitor Vildagle 50 mg tablet (vildagliptin hydrochloride) that the company won by excluding the indication relevant to Galvus’ extended patent. Sources interpret the Korean company’s action was following up with the failed attempt to evade the original drug Galvus’ patent at a patent trial earlier this month against Novartis Korea. According to Korea’s Ministry of Food and Drug Safety (MFDS), Hanmi Pharmaceutical’s withdrawal of the sales approval on Vildagle 50 mg tablet was decided as of July 6. The product received the health authority’s item approval on Jan. 21 and even received reimbursed pricing in last April as well. The drug was initially targeting an early release to the market by applying for the approval without indication based on the original Galvus’ extended patent, which is to last until Mar. 4, 2022. However, the product was not yet released as the patent evasion was not fully approved during the legal proceedings. On July 1, Intellectual Property Trial and Appeal Board rejected Hanmi Pharmaceutical’s request to confirm the negative scope of the original’s patent. Without the complete patent evasion, the product would be able to enter the market only after Mar. 4, 2022 when the original patent term expires. The Korean company could have judged it would be better to reapply for the approval with all indications identical to Galvus. The company has already succeeded in shortening the extended original patent term through the Intellectual Property Trial and Appeal Board, and is ready to launch the product from Aug. 30, 2021. But Ahn-gook Pharmaceutical is also launching its vildagliptin drug from then. As Hanmi Pharmaceutical withdrew the approval, there is no need for Novartis to continue on with the litigation proceedings against MFDS to revoke Hanmi Pharmaceutical’s approval. Novartis has filed litigation against MFDS claiming the government body has neglected its duty to notify the patent owner, according to the Patent-Approval Linkage System, when Vildagle applied for an approval. Now that Hanmi Pharmaceutical has retracted its early release scheme, other pharmaceutical companies also targeting for an early release would inevitably have to revisit the strategy on approval application and challenging the original patent.
- Policy
- The Korean New Deal was confirmed by supplementary budget
- by Kim, Jung-Ju Jul 09, 2020 06:26am
- During the COVID-19 situation, supplementary budget of ₩1.088 trillion was established to strengthen the MOHW for the so-called 'Korean New Deal' project. At the plenary session of the National Assembly on the night of the 3rd, the MOHW focused on ▲strengthening K-disinfection capabilities and R&D investment, ▲ establishing a non-face-to-face basis (infrastructure) for infectious diseases, and ▲expanding the Korean jobs and social safety nets. The government announced that it had increased by ₩34.6 billion compared to the government proposal (₩1.054 trillion). The increase was ₩22.4 billion for the National Immunization Program for influenza targeted at ages 62-64, ▲ ₩12 billion for supporting medical personnel such as COVID-19, ▲ ₩200 million for the establishment of an integrated information system for epidemiological investigations of infectious diseases. ◆Strengthening K-disinfection capabilities and R&D investment =₩48.9 billion was set for the expansion of national immunizations (45.5 million people) for 14~18, 62~64 yearolds in preparation for the possibility of COVID-19 in the future and ₩200.9 billion was set for quarantine items such as level D protective clothing and masks. ₩10.2 billion established for the construction of negative pressure screening clinics in the 67 public health centers in order to expedite medical treatment at local areas, Following the first supplementary ₩400 billion in medical institutions with a sharp drop in sales due to COVID-19, additional ₩400 billion in financing was also established. COVID-19 treatment and vaccine support for clinical trials, advancement of quarantine equipment, and expansion of research and development (R&D) related to the expansion of the infrastructure of the National Institute of Virus and Infectious Diseases will be able to invest ₩140.4 billion. ◆The Korean New Deal project = 5G network, monitoring equipment, etc., including the establishment of non-face-to-face infrastructure for infectious diseases, increased ₩6 billion to minimize the risk of infection in hospitals and establish smart hospitals (3 locations) for efficient treatment. In order to prepare a safe medical treatment system for patients with respiratory diseases and prepare for the possibility of secondary epidemics, ₩50 billion was set up to establish a dedicated respiratory clinic (500 locations), and ₩1.1 billion was confirmed to expand health management projects (130→140 locations) through local clinics and public health centers using ICT devices. ◆Expansion of jobs and social safety netwrok =₩58.3 billion for temporary job support (6,312 people) to provide quarantine support for health centers and hospital-level medical institutions, and extended periods for relief of urgent welfare support requirements (July → end of the year) to expand support for low-income households threatened with livelihood According to the supplementary budget, the total spending by the MOHW in 2020 increased from ₩86.165 trillion to ₩87.146 trillion. Projects that are difficult to execute with COVID-19 will be used as additional financial resources by reducing ₩107.7 billion through restructuring expenses. The MOHW announced that it would thoroughly prepare for the rapid execution of the supplementary budget, and will actively strive to protect people's safety from COVID-19 and support public economy.
- Company
- Phase III clinical trial plan for Rimatil has been submitted
- by Nho, Byung Chul Jul 08, 2020 09:14am
- Chong Kun Dang added a clinical pipeline for COVID-19 treatment following Nafabeltan. On the 18th of last month, Chong Kun Dang began the development of a COVID-19 treatment (clinical phase II) for its anticoagulant and acute pancreatitis treatment drug Nafabeltan (Nafamostat) on the 18th of last month. It is estimated that the mechanism of Nafamostat inhibits protease TMPRSS2, which is known to play a major role in the cell invasion process of COVID-19, and shows several hundred times more antiviral efficacy in human lung cell experiments compared to Remdesivir. On the 30th, IND application for Rimatil (Bucillamine) which is marketed as a rheumatoid arthritis treatment was submitted to the FDA. The Phase III clinical trial for Bucillamine is not directly controlled by Chong Kun Dang, but is hosted by the Canadian pharmaceutical bio company Revive Therapeutics. Rimatil is a safe drug that has been sold in East Asian countries for over 30 years, and is a licensed-introduced drug from Santen company, Japan. If the clinical trial phase III of Bucillamine is successful, Chong Kun Dang, which has exclusive domestic sales rights, will obtain COVID-19 treatment indication. Bucillamine reported that N-Acetyl-L-cysteine significantly alleviates the symptoms of respiratory viral infections and produces significantly positive results in small-scale clinical trials in preclinical and COVID-19 mild patients. According to Revive Therapeutics, the FDA has recommended the clinical phase III of COVID-19 treatment, Bucillamine, and will begin a full-scale clinical trial in the third quarter of this year. The clinical trial is conducted in a double-blind manner in 800 patients with mild COVID-19. Clinical participants receive Bucillamine 100 mg and 200 mg three times a day. The median result is 28 days after the first dose, which is the time when the dose for 210 patients is completed.
- Company
- “Liver cancer option expands, but needs further evidence”
- by Eo, Yun-Ho Jul 08, 2020 05:38am
- Professor Kim Doyoung When a new drug development in a specific area is sluggish, there are two prominent reasons why; either the disease area has low marketability or the drug development itself for the disease is very difficult. In the latter case, a new drug gets an obvious spotlight when it is released to the market. Liver cancer (hepatocellular carcinoma) would be a good example. For over a decade, Nexavar (sorafenib) was technically the only option to be used on liver cancer patients. But now, the disease specialists have heightened anticipation on other options to come. Stivarga (regorafenib) entered the market as a second-line treatment, and Lenvima (lenvatinib) was added as another first-line treatment option at the same level as Nexavar. In the U.S., Tecentriq (atezolizumab) and Avastin (bevacizumab) were approved as a combination therapy recently, which newly added an immunotherapy as an option. The situation in Korea is also taking a step at a time. Early this year, the healthcare reimbursement standard on Nexavar has been adjusted to grant the benefit on patients in Child-Pugh scoring of class B7, a severe case of the disease. The change raised the usability of the pharmaceutical treatment in liver cancer. Daily Pharm interviewed Professor Kim Doyoung of Gastroenterology Department at Severance Hospital and spoke of the hepatocellular carcinoma treatment strategy with more options available now. -First of all, what does expanded coverage on Nexavar mean for a healthcare provider? The patients in Child-Pugh class B7 were considered somewhat of ‘grey area.’ The patient’s liver function level is comparatively close to normal state, but they have risk of developing ascites or jaundice. The patients stuck in the middle did not have a clear answer to choose as a treatment option. These patients need treatment without building liver toxicity. And Nexavar, as proved in various evidences, demonstrates less liver toxicity. Basically, the liver cancer patients hopeless without a proper treatment option can now be treated with Nexavar. -What are some points to consider—like dosage control or administration suspension—when prescribing Nexavar on patients in Child-Pugh class B7? There are no specific precautions to consider. In the GIDEON study that produced global real-world data (RWD) from over 3,000 intent-to-treat participants, Nexavar barely showed much difference between patient groups in Child-Pugh class B7 and Child-Pugh class A. Regardless of class A6 or class B7, normal dosage is recommended but reduced dosage is recommended for patients showing adverse reaction. The dosage does not have to be adjusted from the beginning. -Would the transarterial chemoembolization (TACE) have some changes as Nexavar is now reimbursed and the systemic anticancer therapy option has expanded? Would it be safe to assume this is the period when healthcare providers are trying to reach a consensus on the recommended frequency of TACE and treatment ceasing point? Due to the coverage expansion, some may think of using Nexavar when the patient’s Child-Pugh scoring gets worse after repeated TACE. But the patient’s survival rate would worsen if the Nexavar administration timing is delayed and liver function starts failing according to Child-Pugh scoring. In fact, the talk of when to use systemic anticancer therapy on patients with failed attempt of TACE or refractory condition has continued for over a decade. Although some of the consensus among the healthcare providers has been documented, but it would take a while for the medical practice environment to accept the change and apply it. After practicing TACE for many times, I can see whether or not the patients either should continue on with TACE. Many healthcare providers would agree with me. The decision to continue with TACE should be made promptly but carefully, and switch to another option, if need be. At some point, there was a talk on how beneficial it is to quickly switch to systemic anticancer therapy after TACE. But the argument lacks sufficient evidence in improving the survival rate. -Does that mean, in some cases, there is a concerning factor when following up promptly with a systemic anticancer therapy after TACE? In the past, when Nexavar was the only option of systemic therapy for treating liver cancer, the healthcare providers regarded switching to a systemic anticancer therapy after TACE as a ‘last resort.’ So the treatment switch was not fast enough and it was worrying. But now the healthcare providers seem to agree more that a systemic anticancer therapy is not a ‘last resort,’ as Nexavar is prescribed to patients with comparatively good functioning liver, and also because a follow-on drug Stivarga is commercialized. -As Nexavar is the only systemic anticancer therapy with coverage for patients in Child-Pugh class B7. These patients do not have a choice in later-line treatment with coverage Stivarga’s global REFINE study conducted in a real-world practice conditions in 1,000 patients, diagnosed with unresectable hepatocellular carcinoma, included many of patients in Child-Pugh class B and other more severe cases. Regardless, the study confirmed improved efficacy against Stivarga in global Phase III RESOURCE trial. Based on these findings, Stivarga’s coverage should be expanded to patients in Child-Pugh class B7 for them to resume treatment after Nexavar. -Recently, a combination of immunotherapies was passed by the U.S. health authority. What is your expectation on it? I expect that the prospective competitor of Nexavar to be the combination of immunotherapies. To be honest, I had a great expectation on Opdivo (nivolumab) for treating patients with hepatocellular carcinoma, because its clinical trial had two patients who demonstrated complete response (CR). But using it in the actual practice, the response rate was not as good as I expected. And apparently, Tecentriq combination has exhibited improved result than Nexavar, and it looks ‘good’ at face value. But we need to watch if the combination therapy can show better efficacy in uncontrolled real-world practice conditions. There is also the catch—the patients have to frequently visit the hospital to receive the injection. And of course, the biggest problem of expensive price is still unresolved.
