Anticancer drug development from traditional cytotoxic to targeted therapies: evidence of shorter drug research and development time, and shorter drug lag in Japan

Kawabata-Shoda, Eri; Masuda, Sachiko; Kimura, Hiromichi

doi:10.1111/j.1365-2710.2012.01332.x

Cited by 18 publications

(15 citation statements)

References 14 publications

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“…If joining global studies is not possible, preliminary efficacy studies should be initiated in Japanese patients as soon as possible—at least prior to the United States NDA/BLA/sNDA sBLA. According to a previous report among anticancer drugs approved in 2010 or before in the United States, development of 20 drugs had not commenced in Japan, which is a potential sign of low marketability . It is probably more time‐consuming and expensive to conduct clinical studies for minor cancers than for major cancers.…”

Section: Discussionmentioning

confidence: 99%

“…According to a previous report among anticancer drugs approved in 2010 or before in the United States, development of 20 drugs had not commenced in Japan, which is a potential sign of low marketability. 19 It is probably more timeconsuming and expensive to conduct clinical studies for minor cancers than for major cancers. Fewer patients can be enrolled per investigational site, and relatively more sites are required in clinical studies for minor cancers, compared with those for major cancers.…”

Section: Discussionmentioning

confidence: 99%

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A Significant Anticancer Drug Approval Lag Between Japan and the United States Still Exists for Minor Cancers

Yamashita

Kaneko

Narukawa

2018

Clin Pharma and Therapeutics

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Reports have indicated that approval lag for anticancer drugs between Japan and the United States has decreased. However, if this is also true for drugs used to treat minor cancers remains unknown. We analyzed the anticancer drugs approved in Japan from 2006 to 2016 to compare the drug approval lag based on cancer incidence (major vs. minor cancers) between Japan and the United States. The lag of anticancer drugs for minor cancers had not decreased relative to that a decade ago. Recently, development strategies resulting in longer approval lag were used by pharmaceutical companies more often for the development of drugs used to treat minor cancers than for drugs targeting major cancers, leading to significant differences in the approval lag time between drugs for major and minor cancers. Effective measures that expedite the development of drugs targeting minor cancers in Japan should, therefore, be implemented to shorten lag time.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

A Significant Anticancer Drug Approval Lag Between Japan and the United States Still Exists for Minor Cancers

Yamashita

Kaneko

Narukawa

2018

Clin Pharma and Therapeutics

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“…Due to its efficacy in cancer, [ 1 ] there is a great deal of ongoing research on chemotherapy drugs, ranging from cytotoxic to targeted anticancer drugs. [ 2 ] However, adverse drug reactions, such as hair loss, nausea, vomiting, and loss of appetite, remain problematic. [ 3 ] Therefore, it is important to ensure that appropriate amounts of chemotherapeutic drugs are delivered accurately to the lesion to minimize side effects.…”

Section: Figurementioning

confidence: 99%

A Needle‐Type Microrobot for Targeted Drug Delivery by Affixing to a Microtissue

Lee

Kim

et al. 2020

Adv Healthcare Materials

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A needle‐type microrobot (MR) for targeted drug delivery is developed to stably deliver drugs to a target microtissue (MT) for a given period time without the need for an external force after affixing. The MRs are fabricatedby 3D laser lithography and nickel (Ni)/titanium oxide (TiO2) layers are coated by physical vapor deposition. The translational velocity of the MR is 714 µm s−1 at 20 mT and affixed to the target MT under the control of a rotating magnetic field. The manipulability of the MR is shown by using both manual and automatic controls. Finally, drug release from the paclitaxel‐loaded MR is characterized to determine the efficiency of targeted drug delivery. This study demonstrates the utility of the proposed needle‐type MR for targeted drug delivery to MT with various flow rates in vitro physiological fluidic environments.

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“…Chemotherapeutics are highly effective in vitro , but their applications in vivo often suffer from issues such as poor control of spatial distribution and activity over time (5, 6). In addition to these factors, solubility and chemical stability in complex biological environments limit the clinical translation and application of many promising anticancer chemotherapeutics (7–9).…”

Section: Introductionmentioning

confidence: 99%

Photo-Inducible Crosslinked Nanoassemblies for pH-Controlled Drug Release

2013

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Purpose To control drug release from block copolymer nanoassemblies by variation in the degree of photo-crosslinking and inclusion of acid sensitive linkers. Methods Poly(ethylene glycol)-poly(aspartate-hydrazide-cinnamate) (PEG-CNM) block copolymers were prepared and conjugated with a model drug, doxorubicin (DOX), through acid sensitive hydrazone linkers. The block copolymers formed photo-inducible, self-assembled nanoassemblies (piSNAs), which were used to produce photo-inducible crosslinked nanoassemblies (piCNAs) through UV crosslinking. The nanoassemblies were characterized to determine particle size, surface charge, pH- and crosslinking-dependent DOX release, in vitro cytotoxicity, and intracellular uptake as a function of photo-crosslinking degree. Results Nanoassemblies with varying photo-crosslinking degrees were successfully prepared while retaining particle size and surface charge. Photo-crosslinking caused no noticeable change in DOX release from the nanoassemblies at pH 7.4, but the DOX-loaded nanoassemblies modulated drug release as a function of crosslinking at pH 6.0. The nanoassemblies showed similar cytotoxicity regardless of crosslinking degrees, presumably due to the low cellular uptake and cell nucleus drug accumulation. Conclusion Photo-crosslinking is useful to control drug release from pH-sensitive block copolymer nanoassemblies as a function of crosslinking without altering the particle properties, and thus providing unique tools to investigate the pharmaceutical effects of drug release on cellular response.

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Anticancer drug development from traditional cytotoxic to targeted therapies: evidence of shorter drug research and development time, and shorter drug lag in Japan

Abstract: The emergence of new molecularly targeted agents has contributed to reducing the approval lag, most likely due to improvements in R&D strategy.

Cited by 18 publications

References 14 publications

A Significant Anticancer Drug Approval Lag Between Japan and the United States Still Exists for Minor Cancers

A Significant Anticancer Drug Approval Lag Between Japan and the United States Still Exists for Minor Cancers

A Needle‐Type Microrobot for Targeted Drug Delivery by Affixing to a Microtissue

Photo-Inducible Crosslinked Nanoassemblies for pH-Controlled Drug Release

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