Immune checkpoint inhibitors for the treatment of non-small cell lung cancer: A comparison of the regulatory approvals in Europe and the United States

Zaim, Remziye; Redekop, Ken; Groot, Carin A Uyl-de

doi:10.1016/j.jcpo.2022.100346

Cited by 6 publications

(10 citation statements)

References 10 publications

(12 reference statements)

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“…As the costs for drug manufacturers to meet regulatory requirements can be excessive and doubled, there are concerns that regulation will hinder drug development and delay patient access to innovation. 47 The USA FDA review process is fast, as it requires manufacturers to demonstrate that their drugs are of great interest to public health, particularly from the point of view of therapeutic innovation, filling a gap in the market. 47 The use of immunotherapy in oncology has grown rapidly over the years, but ICIs are a relatively recent drug class, with their first agent approved (ipilimumab) by the US FDA only in 2011, followed by nivolumab in 2014.…”

Section: Discussionmentioning

confidence: 99%

Lesions in the oral mucosa associated with the use of checkpoint inhibitors: A bibliometric and critical review

Jural,

Estanho,

Pereira

et al. 2023

Special Care in Dentistry

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AimsImmune‐related adverse events (irAEs) linked to the use of immune checkpoint inhibitors (ICIs) have become increasingly frequent. To perform a bibliometric and critical review of the general panorama of publications on oral mucosal lesions (OML) associated with ICIs.Methods and ResultsSystematized searches were performed in four databases. The included studies were organized and bibliometric and clinical data were extracted and analyzed using VantagePoint and Microsoft Excel. Most of the 35 included studies were reports or case series (n = 33/94.2%). The American authors stood out (n = 17/48.5%), with the majority presenting only one publication. Independent groups carried out most of the publications (n = 31/88.5%). Over the years, publications have increased for users of nivolumab and pembrolizumab. In 21 studies (60%), OML were more common in men, between the 6th and 9th decades of life and who had lung carcinoma (n = 13/37.1%). Pembrolizumab (n = 17/48.5%) was the most used ICI. The patients were affected by one or more OML, including: ulcers (n = 28/80%) and erythema (n = 11/31.4%). Systemic corticosteroids (n = 24/68.5%) and the discontinuation of ICI use (n = 18/51.4%) were the main approaches used.ConclusionOML related to the use of ICIs have become increasingly common. More accurate data need to be published.

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Section: Discussionmentioning

confidence: 99%

Lesions in the oral mucosa associated with the use of checkpoint inhibitors: A bibliometric and critical review

Jural,

Estanho,

Pereira

et al. 2023

Special Care in Dentistry

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“…Our study also found that only 5 of the 9 ICIs marketed in the United States gained approval in China, which was consistent with the ICIs approved in Japan, while all these ICIs marketed in the United States gained regulatory approval at a similar time in Europe. 25,26,31,32 The reason most likely was that the Asian patients were not enrolled in the global pivotal clinical trials of the ICIs, [33][34][35][36][37][38] shown a very prominent performance in the field of hematological malignancies, with six CAR T cell therapies approved by the FDA. 46 Similarly, two CAR T cell therapies were approved by the NMPA.…”

Section: Approval Status and Primary Endpointmentioning

confidence: 99%

“…17 approved by the FDA, and so forth. 15,[18][19][20][21][22][23][24][25][26] Our study comprehensively compared the ICIs marketed in China and the United States, with a focus on the approval time, targets, indication layout, regulatory review time, launch delay, and so forth, which could provide a reference for making clinical development strategies and marketing applications for subsequent ICIs in China and the United States.…”

Section: Introductionmentioning

confidence: 99%

“…Some of China's enterprises are seeking new drug approval for domestically developed ICIs from the FDA. Previous studies primarily focused on reviewing the status of investigational ICIs, or current advances of ICIs in a specific tumor type (eg, melanoma, nonsmall‐cell lung carcinoma [NSCLC]) or reviewing ICIs approved by the FDA, and so forth 15,18‐26 …”

Section: Introductionmentioning

confidence: 99%

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The regulatory approvals of immune checkpoint inhibitors in China and the United States: A cross‐national comparison study

Yan

Zhang

et al. 2023

Intl Journal of Cancer

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Immune checkpoint inhibitors (ICIs) are currently one of the most popular treatment methods for cancers. Several ICIs have been approved in China and the United States. We created a database of approved ICIs by extracting the information of interest from the drug labels and reviewing documents disclosed on the official websites of the US Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) and compared the difference between the marketed ICIs in China and the United States regarding the number of indications, tumor types, review time, treatment setting, and so forth. Until June 30, 2022, 9 and 15 ICIs had been approved for 86 and 58 indications in the United States and China, involving 20 and 14 types of tumors, respectively. The correlation between indications and disease incidence was higher in China (r = 0.64) than in the United States (r = 0.45). About half of the indications were approved as first-line therapies in combination with chemotherapy, target therapy, or immunotherapy. Over 30% of indications were approved under accelerated or conditional approval in the two countries. A shorter regulatory review time was required by the FDA (median:181 days) compared to the NMPA (median: 279 days) for the new indication approval. Five ICIs marketed in China were approved by the FDA before the NMPA, with the median launch delay for the same indication of 344 days in China. A differentiated clinical development program that focuses on meeting unmet needs may bring new success for subsequent ICI products.

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“…Recently, there have been theoretical research efforts to consider additional dimensions of benefit, including patients’ risk preferences in their treatment choices ( 11 ). Value assessment frameworks quantifying clinical and economic outcomes of health technologies are often used to quantify the net value of NSCLC therapies ( 12 ). For example, the value frameworks used by the National Institute for Health and Care Excellence (NICE) and the Institute for Clinical and Economic Review (ICER) use average health-related quality of life (HRQoL) as a key measure of health benefit ( 13 – 15 ).…”

Section: Introductionmentioning

confidence: 99%

Incorporating risk preferences of patients in the valuation of immune checkpoint inhibitors for non-small cell lung cancer

Zaim

Redekop²,

Groot³

2023

Front. Oncol.

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Immunotherapy offers a distinctive mechanism of action compared to traditional treatments, arising from additional value dimensions that may not be captured in standard health technology assessments. Cancer patients may have the expectation that immunotherapy provides durable, long-term survival gains. Moreover, some patients may be willing to take a ‘risk’ to undergo immunotherapy to achieve better survival outcomes. We reviewed quantitative methods that explored patients’ risk preferences in their non-small cell lung cancer (NSCLC) treatment choices, in PubMed (MEDLINE), from January 1, 2015, until July 1, 2022. The consideration of a value dimension (‘hope’) based on patients’ risk-seeking preferences is specifically addressed for the valuation of immune checkpoint inhibitors in NSCLC. We reported that the quantitative methods that aim to measure patients’ risk preferences or ‘hope’ empirically are emerging. Value assessments should not only comprise survival improvements for the mean or median patient but also consider methods that reflect durable, long-term overall survival gains for risk-seeking patients. However, the published evidence for incorporating ‘hope’ based on patients’ stated preferences for uncertain treatment profiles is not strong, and future research could strengthen this evidence base. We encourage further research on the development and validation of quantification methods to incorporate ‘hope’ and risk preferences of patients treated with immunotherapy for NSCLC and beyond.

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Immune checkpoint inhibitors for the treatment of non-small cell lung cancer: A comparison of the regulatory approvals in Europe and the United States

Cited by 6 publications

References 10 publications

Lesions in the oral mucosa associated with the use of checkpoint inhibitors: A bibliometric and critical review

Lesions in the oral mucosa associated with the use of checkpoint inhibitors: A bibliometric and critical review

The regulatory approvals of immune checkpoint inhibitors in China and the United States: A cross‐national comparison study

Incorporating risk preferences of patients in the valuation of immune checkpoint inhibitors for non-small cell lung cancer

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