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- 2026-04-14 13:27:03
- Company
- Daewoong & Dong-A succeeded in overcoming patent of Otezla
- by Kim, Jin-Gu May 27, 2021 05:56am
- Daewoong & Dong-A ST succeeded in avoiding one of two patents of Otezla (Apremilast), a psoriasis treatment drug worth ₩2.46 trillion in global sales. While Amgen, the original company, has yet to officially release Otezla in Korea, the two companies are on the verge of releasing generics early. According to the pharmaceutical industry on the 26th, the Intel Property Trial and Appeal recently ruled in a passive right-checking trial on Otezla's patent filed by Daewoong and Dong-A ST against Amgen. There are two patents, use patent, which expires in March 2028, and formulation patent, which expires in December 2032. The patents avoided by Daewoong and Dong-A ST are formulation patent that expire later. In addition to the two companies, Chong Kun Dang, Dongkoo bio, Mothers, Yuyu, Huons, and Cosmax have also filed for the same judgment, but no conclusion has been reached yet. Eight companies including Daewoong and Dong-A ST also filed for invalidation of the case against use patent. If Daewoong and Dong-A ST overcome use patent, they can release generics early after November 2023 when Otezla PMS expires. There is a possibility that Amgen will appeal against the verdict, and generic companies should also succeed in proving their biological equivalence with the original. Otezla is Amgen's global blockbuster psoriasis treatment. As of last year, it made $2.2 billion in global sales. In 2017, Celgene received a domestic license and challenged for the benefit, but the launch was delayed as it failed to be paid due to differences in opinions between insurance authorities and companies on prices. As Celgene was acquired by BMS in 2019, South Korea's release plan was delayed even more. Initially, BMS tried to have the copyright of Otezla, but the U.S. Federal Trade Commission (FTC) ordered the sale because it was concerned about monopolies. Eventually, BMS sold Otezla's copyright to Amgen. Amgen acquired global copyright for $13.4 billion. As a result, domestic copyrights were transferred to Amgen. Amgen is trying to negotiate with insurance authorities, but it is still said that it will not be easy to apply the benefit.
- Company
- AD drug ‘Dupixent’ records ￦13.5 bil. in Q1 with reimb.
- by An, Kyung-Jin May 27, 2021 05:56am
- Sanofi Genzyme’s biologic medication ‘Dupixent (dupilumab),’ which was finally approved for reimbursement after a long wait, is creating a sensation in the market. After receiving approval for its reimbursement in severe atopic dermatitis last year, sales of Dupixent rose steeply to exceed 10 billion won in the first quarter this year. With the indication expanded to pediatric patients earlier this year, its sales growth is expected to accelerate further. According to the market research institution IQVIA, sales of Dupixent recorded 13.5 billion won in the first quarter this year. This was a 306.2% YoY increase compared to the same quarter of the previous year, in which Dupixent recorded 3.3 billion won in sales. With the surging sales, Dupixent sold over 10 billion won in quarterly sales for the first time. Compared to the 1.5 billion won in 2019 Q1, the size of quarterly sales leaped ninefold in 2 years. Dupixent is the first targeted biologic developed for the treatment of moderate-to-severe atopic dermatitis that is not well controlled with prescription topical therapies or who cannot use topical therapies. It selectively inhibits interleukin-3 and interleukin-4 proteins, which are known causes of adult atopic dermatitis. Sanofi Genzyme received marketing authorization for Dupixent in March 2018 for the treatment of moderate-to-severe atopic dermatitis in adults and released the drug in August of the same year. However, its performance after the initial release was not up to par. Starting with a record of 0.2 billion won in Q3 2018, it exceeded 1 billion won in Q4; however, its quarterly sales since then remained in the 1 billion to 2 billion won range. Even in Q4 2019, it was not able to record 3 billion won and sales remained at 2.7 billion won. The non-reimbursed monthly cost of 2 million won (based on 2 doses/month) remained as a financial barrier for prescribing Dupixent. Sanofi Genzyme had applied for the reimbursement of Dupixent to the Health Insurance Reimbursement and Assessment Service (HIRA) in February 2019. However, the agenda was not chosen for deliberation by the Drug Reimbursement Evaluation Committee for 5 years due to its excessive drug price. However, in the same year, the government had decided to expand eligibility of the Risk-sharing agreement scheme, and Dupixent’s eligibility was recognized through the RSA track. After 2 months of pricing negotiations, the drug was finally granted reimbursement for severe atopic dermatitis from January last year. After the reimbursement approval, Dupixent’s sales soared. In 2020, Dupixent’s sales rose from 3.3 billion won in Q1 to 5.2 billion won in Q2, then to 7.1 billion won in Q3 and to 8 billion won in Q4. In total, Dupixent recorded 23.6 billion won in sales last year. This year, its sales already recorded 13.5 billion won in the first three months, and a new sales record is expected to be set this year. The industry expects the sales growth of ‘Dupixent’ to continue for the time being. In October last year, Sanofi Genzyme additionally released a ‘Dupixent’ 200mg formulation for adolescents weighing less than 60kg with moderate-to-severe atopic dermatitis. In addition, its indication extended to pediatric patients under 11 years of age since March. Dupixent’s indication now covers all atopic dermatitis patients aged 6 years or older.
- Company
- Sales of EGFR anticancer drug Tagrisso have been put on hold
- by An, Kyung-Jin May 27, 2021 05:56am
- The market for EGFR lung cancer drugs has been put on hold. Sales of Tagrisso, a third-generation drug, have declined since its benefit. As new products emerge one after another, the market is expected to change within this year. According to IQVIA, a pharmaceutical research institute, the size of Korea's market for EGFR tyrosine kinase inhibitors (TKI) in the first quarter of last year was ₩35.5 billion, down 2.9% from ₩36.5 billion a year earlier. South Korea's EGFR-TKI market increased to ₩38.9 billion in sales in third quarter of last year as it continued to grow since first quarter of 2017, but fell for second consecutive quarter. EGFR-TKI is a targeted anti-cancer drug prescribed to patients with metastatic non-small cell lung cancer (NSCLC) accompanied by EGFR mutations. EGFR mutations are a very common mutant type observed in 30–40% of non-small cell lung cancers that account for 80–85% of lung cancer, occurring between exon 18 and exon 21. It is known that Asian markets, including Korea, China, and Japan, are larger because they are more popular than Westerners. EGFR-TKI, which is currently on the market in South Korea, includes first-generation drugs Iressa (Gefitinib), Tarceva (Erlotinib), second-generation Giotrif (Afatinib), and third-generation Tagrisso (Osimertinib). Among the five products, the total size of the market tends to depend on the sales of Tagrisso. Tagrisso's first-quarter sales rose 3.1% year-on-year to ₩24.4 billion. As of first quarter, Tagrisso accounts for 68.9% of all markets. It is maintaining a four-fold gap with Giotrif, the second-largest item in sales. AstraZeneca's Tagrisso was approved by the MFDS in May 2016 for "local progressive or metastatic non-small cell lung cancer patients with EGFR-T790M mutations confirmed after EGFR-TKI administration." It is prescribed as a secondary treatment for non-small cell lung cancer patients who have developed resistance after administration of the existing first and second generations of EGFR-TKI. Tagrisso's sales soared in December 2017 when it was covered by health insurance benefits as a secondary treatment. Tagrisso's sales, which started at ₩2.3 billion in the first year of release and stayed at ₩10.3 billion in 2017, jumped 5.8 times to ₩59.4 billion in 2018. Although it continued to grow rapidly with ₩79.2 billion in 2019 and ₩106.5 billion in 2020, it is not as good as it used to be recently. After setting its own record of ₩27.9 billion in sales in third quarter of last year, it continued to decline for two consecutive quarters. The decline in Tagrisso sales varies. Tagrisso was added to the primary therapy indication in Korea in December 2018, and the reimbursement process has been stalled for more than two years. Tagrisso, which is not covered by insurance, costs ₩217,782 per 80mg, more than ₩6 million a month. Even if it meets the standards, there are many patients who cannot be treated because of the cost burden.The release of generics also seems to have had some impact. Since last year, global clinical subjects have been actively recruiting third-generation EGFR-TKI Leclaza (Lazertinib) therapy developed by Yuhan. Pfizer's Vizimpro (Dacomitinib), a small but second-generation drug, also began to be prescribed late last year after being listed on the benefit. Sales of Giotrif in the first quarter of last year were ₩5.2 billion, up 10.1% year-on-year. This is its biggest sales since its launch in South Korea. The remaining EGFR-TKI sales are sluggish. First quarter sale of Iressa by AZ were ₩4.2 billion, down 29.9% from a year earlier. During the same period, Roche's Tarceva recorded ₩1.5 billion in sales, down 29.6%. Vizimpro's sales in fourth quarter of last year and first quarter of this year are still insignificant. Industries are predicting that changes in EGFR-TKI markets will also accelerate during second half of this year. It is observed that competition between the 3rd generation EGFR-TKI will intensify after the launch of the domestic new drug Leclaza (Lazertinib). Leclaza was approved by the MFDS in January as a treatment for patients with EGFR T790M mutations that had previously been treated with EGFR-TKI. The HIRA's Cancer Drugs Benefit Application Committee, which was held in February, has been properly assessed and negotiated between the Pharmaceutical Benefits Advisory Committee and the NHIS. It is predicted that sales will begin in earnest from the second half of this year after completing the registration process quickly.
- Policy
- Combination vaccine Priorix-tetra by GSK has been revoked
- by Lee, Tak-Sun May 27, 2021 05:55am
- The final license will be revoked because GSK's licensed combination vaccine "Priorix-tetra" did not submit the review data in November 2013. The vaccine is the first MMRV vaccine in Korea to have chickenpox prevention added to existing measles, rubella, and infectious mastitis. However it seems that GSK has not been able to actively respond to the cancellation as demand in Korea has decreased. The MFDS ordered GSK's Priorix-tetra to be revoked on the 17th. It will take place as of June 1st. This product is a live virus vaccine mixed with measles, mumps, rubella and chickenpox, and was approved by the MFDS in November 2013. In particular, it was comfortable because the existing MMR vaccine combined with chickenpox prevention requires a second injection. However, there was not much demand for MMRV vaccines because the NIP separately designated MMR vaccines and chickenpox vaccines. Furthermore, GSK's MMR vaccine Priorix is included in the NIP. Priorix has been co-sold by SK Bioscience since this year. It seems that the company did not actively respond even if the MFDS requested unfulfilled reexamination data. This is because it believes that it will be difficult to increase demand in the future. Eventually, the vaccine disappeared from the domestic market after seven years of approval.
- Company
- MSD's HIV market entry to be discussed at June's DREC meetin
- by Eo, Yun-Ho May 26, 2021 06:06am
- MSD is pushing to enter the HIV treatment market in Korea. Industry sources have reported that MSD Korea’s once-daily fixed-dose HIV combination tablet ‘Delstrigo (doravirine/lamivudine/tenofovir)’ will be reviewed by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee (DREC) meeting held in June next month. Considering that the company applied for Delstrigo's reimbursement listing in January, its listing process is proceeding relatively smoothly. MSD Korea had applied for the reimbursement of Delstrigo for its 'treating HIV-1 infection in adult patients with no prior antiretroviral treatment experience’ indication. Among its ingredients, the ‘doravirine 100mg’ ingredient was approved by the Ministry of Food and Drug Safety (MFDS) on November 22nd, 2019, under the name ‘Pifeltro,' to be administered in combination with other antiretrovirals. Pifeltro and Delstrigo are both indicated for treating HIV-1 infection in adult patients with no prior antiretroviral treatment experience. Delstrigo’s efficacy was confirmed in the DRIVE-AHEAD trial. In the trial, Delstrigo was non-inferior to the efavirenz/emtricitabine/tenofovir combination. Also, 84% of the patients in the Delstrigo group achieved viral suppression at week 48 ( viral suppression of HIV-1 RNA
- Company
- Sales of obesity drugs have been on the decline
- by An, Kyung-Jin May 26, 2021 06:05am
- The rise in the obesity treatment market, which had high sales, has slowed. The effects of the new products of Saxenda and Qsymia has decreased. According to IQVIA, a pharmaceutical research institute, the domestic obesity treatment drug market was ₩32 billion in the first quarter, down 2.4% from ₩32.8 billion a year earlier. Although its sales in 3rd quarter of last year were at an all-time high of ₩38.5 billion, it fell for the second consecutive quarter. This is similar to the amount of sales immediately after Belviq (Lorcaserin) was removed due to safety issues in the fourth quarter of 2019. The reason why the obesity drug market is sluggish is mainly because of large items. Sales of Saxenda (Liraglutide) by Novonodisk , which remained the No. 1 product in the market, have fallen significantly, and even Alvogen Korea's "Qsymia" (Phentermine/Topyramate), the No. 2 item, seems to have entered a period of stagnation. Saxenda's first-quarter sales fell 25.2% year-on-year to ₩6.7 billion. It fell from ₩9.7 billion in the third quarter of last year to ₩8.8 billion in the fourth quarter of last year and its quarterly sales fell sharply again. It is down 43.7% from ₩19.9 billionin third quarter of 2019 when it set its own best record. Saxenda is the world's first obesity treatment drug licensed as a Glucagon-Like Peptide 1 (GLP-1) similar. The ingredients are the same as Victoza, which is prescribed in patients with type 2 diabetes, but differ only in dosage & indication. Sales have increased significantly over the past two years due to the formation of a perception that it is relatively safe because it acts as the same mechanism as the body's GLP-1 to suppress appetite and induce weight loss. Saxenda ranked No. 1 in sales of obesity drugs in Korea with sales of ₩5.6 billion in the fourth quarter of 2018. Its sales in the first quarter of 2019 were ₩10.5 billion, and it set its own record of ₩1.1 billion in the third quarter of the same year. Saxenda had a market share of 33.7%. Although its sales volume is the largest among obesity drugs still on the market in Korea, its market share has decreased significantly. As of the first quarter, Saxenda's market share narrowed to 21.0% and the share gap with the second-largest product (18.5%). The domestic obesity treatment market ranked second in sales of obesity drugs in Korea at the same time as Qsymia was released in January last year with sales of ₩4.3 billion in the first quarter of last year. Since then, sales have risen sharply due to ₩5.8 billion in the second quarter and ₩ 6.5 billion in the third quarter. Qsymia's accumulated first-year sales amounted to ₩22.5 billion. The domestic obesity treatment market enjoyed an all-time boom despite the negative effects of Covid-19 and the recovery and disposal of Belviq. Qsymia's sales have also declined since its release. Qsymia sold $5.9 billion in the first quarter. It rose 37.2% year-on-year, but has stagnated since the fourth quarter of last year. Qsymia is a combination of Phentermine and Topiramate, where Alvogen Korea secured domestic copyrights from Vivus in the U.S. in 2017. Alvogen Korea signed a joint sales contract with Chong Kun Dang at the end of 2019 and started full-scale sales marketing from early last year. Through the sales experience of Furring and Furimin, it is diagnosed that Qsymia was able to enter the market quickly as the sales power of Alvogen Korea and Chong Kun Dang, which have worked in the domestic obesity treatment market for a long time, created synergy. Although it is an oral drug, the fact that the dose of the psychotropic drug is relatively low and long-term prescription is possible is also considered a success factor. Overall, sales performance of other products except Saxenda and Qsymia is sluggish. Of the 110 products sold in the domestic market, Saxenda and Qsymia have a market share of nearly 40%. More than 110 items are competing for the remaining 60% market. In addition to Saxenda and Qsymia, Daewoong's Dietamin, Huons' Hutermin, and Alvogen Korea's Furing were only five products that exceeded ₩1 billion in sales in the first quarter. Dietamin's first quarter sales were ₩2.1 billion, down 2.2% from a year earlier. Until the fourth quarter of 2019, it was the second-highest-selling item after Saxenda, but its market influence declined sharply with the release of Qsymia. The sales gap with Qsymia is more than double. Sales of Hutermin and Furing fell 5.0% and 13.5% respectively compared to last year.
- Company
- Tylenol sales up 43% for use ‘after COVID-19 vaccination'
- by Kim, Jin-Gu May 26, 2021 06:05am
- Sales of Tylenol surged 43% YoY, compared to the same quarter of the previous year in the OTC pain medication market. This is in stark contrast to the double-digit decline in sales of other pain medications. Analysts believe that this increase in sales was influenced by the government’s guidance to ‘use Tylenol when experiencing side effects after COVID-19 vaccination.’ However, in the prolonged Tylenol shortage, companies with other analgesic brands have been employing aggressive marketing strategies targeting the gap, which may affect their Q2 sales and thereafter. ◆₩10.2 billion → ₩14.7 billion in one year… Tylenol makes new quarterly sales record According to the market research firm IQVIA, Tylenol sales recorded ₩14.7 billion in Q1 this year. This is a 43% increase from the ₩10.2 billion recorded in Q1 of the previous year and a new record in its quarterly sales. Analysts believe the guidance by the disease control and prevention authorities in Korea influenced the increase of Tylenol sales. Since starting COVID-19 vaccinations earlier this year, authorities have directed the vaccinated subjects to ‘take Tylenol if side effects such as fever occur.’ Upon strong opposition on the use of a specific product name by relevant groups including the Korean Pharmaceutical Association, the authorities explained that they “used the product name (Tylenol) to enable better understanding for the public and the elderly, as they are more familiar with the brand name.” After the incident, the authorities have changed their wording from ‘Tylenol' to ‘acetaminophen.' Despite such modification, frontline pharmacies say that customers still keep coming for Tylenol. In fact, most pharmacies voice that the Tylenol shortage has worsened after the authorities' guidance. “Almost all customers who come looking for Tylenol are those that will soon be vaccinated,” a pharmacist from Daejeon said. “Even when I recommend a different product with the same ingredient because have we're out of stock, 8 to 9 out of 10 people refuse to buy anything else but Tylenol.” Some analysts see this as an increased tendency of patients and consumers to prefer buying highly recognized products due to the prolonged COVID-19 pandemic. An industry official said, “Tylenol has constantly made strong sales in the COVID-19 pandemic. The guidance from the authorities and increased preference for known brands seem to have made a combined impact." ◆Other acetaminophen products all see a decrease in sales However, most major analgesics other than Tylenol have seen a decline in sales in the same period. In particular, even other analgesics with the same acetaminophen ingredient were not able to avoid a sales decline. Sales of Geworin, the second-most sold analgesic in Korea, fell 44% YoY from ₩6.6 billion in Q1 last year to ₩3.7 billion in Q1 this year. Chong Kun Dang’s Penzal’s sales also fell 26% from ₩1.3 billion to ₩1 billion. Sales of Dong-A Pharmaceutical's acetaminophen product, Champ Syrup, and its ibuprofen product, Champ Ibufen, fell by 53% and 59%, respectively. Most ibuprofen products also saw a sales decline. Sales of Daewoong Pharmaceutical's EZN6 fell 15% from ₩2 billion to ₩1.7 billion. Hanmi Pharmaceutical’s Maxibupen fell nearly half from ₩1.4 billion to ₩7 billion. Sales of Ahn-Gook Pharmaceutical’s Anyfen also fell 37%, and Samil Pharmaceutical’s Brufen fell 44%. GC Pharma’s Taxen was the only major analgesic other than Tylenol to see an increase in sales. Its sales increased 28% from ₩1.4 billion in Q1 last year to ₩1.7 billion in Q1 this year. However, the sales decline of most analgesics may be due to the unusually high sales recorded in Q1 last year. In Q1 last year, the spread of COVID-19 had raised public anxiety, which led to a temporary increase in sales of all household medicines including analgesics. ◆Domestic companies start ‘vaccine's side effect marketing… may turn around sales in Q2 Attention is focused on how the market may change after Q2. With the prolonged Tylenol shortage, pharmaceutical companies with acetaminophen products have started active marketing activities targeting the use of their drugs for the ‘management of side effects after vaccination.’ Samjin Pharm and Daewoong Pharmaceutical had already strengthened relevant marketing activities, and sales of some analgesics such as Geworin Cooldown, EZN6 Ace have already started to increase gradually. “Considering that the vaccination rate in Korea has not even reached 10% yet, the high demand for acetaminophen is expected to continue for a while,” an industry official said. “If the Tylenol shortage continues, sales of other analgesics with the same ingredient may increase.”
- Company
- Sales of Prevenar 13 in the first quarter fell 46%
- by Chon, Seung-Hyun May 26, 2021 06:05am
- Sales of Pfizer's pneumococcal vaccine Prevenar 13 fell by half year-on-year in the first quarter. Although sales soared after the spread of Covid-19 last year, it seems to have returned to the previous year's level this year. According to IQVIA, a pharmaceutical research institute on the 24th, Prevenar 13's sales in the first quarter fell 46.7% year-on-year to ₩9.4 billion. It shrank from $17.6 billion in the first quarter of last year to half in a year. Compared to ₩21.1 billion in the fourth quarter of last year, sales decreased by 55.5% in the first quarter. Quarterly sales of Prevenar 13 trend (unit: ₩1 million, data: IQVIA) Prevenar 13 posted quarterly sales of around ₩10 billion. It broke sales record in first quarter of last year by increasing 52.2% from previous year to ₩17.6 billion. In the second and third quarters of last year, Prevenar 13 set a new record for consecutive quarterly sales. It soared to around ₩20 billion in the quarter. Over the past year, Prevenar 13 posted sales of ₩81.3 billion, up 64.8% from a year earlier. Prevenar 13 is PCV13 that prevents infection to 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). It is a vaccine that can be inoculated at all ages over 6 weeks of age, with Chong Kun Dang for adults in charge of nationwide distribution and Korea Vaccine for infants and children. Although Prevenar 13 does not prevent pneumonia caused by COVDI-19, demand for inoculation among adults surged last year as some experts argued that it could help weaken pneumonia symptoms. However, as COVID-19 pandemic has been prolonged, sales of Prevenar 13 have also returned to the previous year's level. Sales of Prevenar 13 fell 18.9% in the first quarter from the first quarter of 2019. Quarterly sales of Prevenar 13 fell below ₩10 billion in about two years since the second quarter of 2019. As about a year has passed since the COVID-19 pandemic, fears of COVID-19 decreased and demand for Prevenar 13 has returned to the previous year's level as vaccinations have begun in earnest. Some analysts say that demand has decreased relatively this year because people who planned to vaccinate pneumoniae temporarily flocked last year.
- Policy
- 55,000 doses of Mordena vaccines will be released in a week
- by Kim, Jung-Ju May 26, 2021 06:05am
- Moderna's 55,000 mRNA-like COVID-19 vaccines will arrive in Korea next Monday, or the 31st. The COVID-19 vaccine, developed by foreign pharmaceutical companies in Korea, is the third since AstraZeneca and Pfizer, and has been rapidly introduced since the signing of an MOU between health authorities and companies. The MOHW announced on the 24th that 55,000 Moderna vaccines will arrive at domestic airports around next Monday. Afterwards, Moderna's products will be approved by the licensing authorities and will be officially used. While President Moon Jae-in 's visit to the united states, the South Korean Ministry of Trade, Industry and Energy and the MOHW signed an MOU with Moderna to cooperate in discussing investment and production in Korea. The main contents include ▲ Moderna's efforts to invest in mRNA vaccine production facilities in Korea and recruit Korean workers, and ▲the Korean government's cooperation to support Modena's investment activities in Korea. Moderna signed a contract with Samsung Biologics for consignment production of vaccines and plans to produce hundreds of millions of doses of vaccine and supply it to the world starting from the third quarter. It is expected that it will have a positive impact on domestic supply and demand.
- Company
- 1st reimb. discussion to start on 2 tumor-agnostic therapies
- by Eo, Yun-Ho May 25, 2021 06:04am
- Two types of tumor-agnostic therapies seek reimbursement listing in Korea. Industry sources say Roche Korea’s Neurotrophic tyrosine receptor kinase(NTRK) Rozlytrek (entrectinib) and Bayer Korea’s ‘Vitrakvi (larotrectinib)’ will be up for deliberation by the National Health Insurance Service's (NHIS) Cancer Drug Review Committee meeting on the 26th. Rozlytrek and Vitrakvi are indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. In other words, the two drugs may be used in virtually all cancer types confirmed with an NTRK gene. Both drugs will seek to receive reimbursement approval through the pharmacoeconomic evaluation (PE) exemption track. As the two drugs are in the same class, the government will be discussing reimbursement listing in coordination with the two companies Rozlytrek and Vitrakvi were approved based on a single-arm study that did not involve a control arm. As it already meets subparagraph 2 of the PE exemption criteria, if the committee deems the other conditions are also met, it is likely that the drug will have not much difficulty in receiving the exemption. Rozlytrek’s approval was based on results from the Phase I/II STARTRK-NG study in pediatric patients, as well as data from the integrated analysis of the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials. In the Phase II STARTRK-2 trial, over half of the patients with NTRK fusion-positive, advanced solid tumors receiving Rozlytrek demonstrated a reduction in tumor size with an objective response rate (ORR) of 56.9%. Objective responses to Rozlytrek were observed across 10 different solid tumor types, and the median duration of response (DoR) was 10.4 months. Vitrakvi’s approval was based on data from the Phase II NAVIGATE trial in adult and pediatric patients 12 years or older and the Phase I/II pediatric SCOUT trial in pediatric patients 1 month or older to 21 years with advanced cancer or with primary CNS tumors. Efficacy results from three clinical trials in 55 patients with confirmed NTRK gene fusion showed that Vitrakvi demonstrated an ORR of 75% and partial response rate of 53% in numerous tumor types (including soft tissue sarcoma, infantile fibrosarcoma, salivary gland tumor, thyroid cancer, melanoma, colorectal cancer, gastrointestinal stromal tumors (GISTs), cholangiocarcinoma, gallbladder cancer, breast cancer, and pancreatic cancer).
