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MAbs
2018[Feb]; 10
(2
): 183-203
PMID29300693
show ga
The pace of antibody therapeutics development accelerated in 2017, and this
faster pace is projected to continue through 2018. Notably, the annual number of
antibody therapeutics granted a first approval in either the European Union (EU)
or United States (US) reached double-digits (total of 10) for the first time in
2017. The 10 antibodies granted approvals are: brodalumab, dupilumab, sarilumab,
guselkumab, benralizumab, ocrelizumab, inotuzumab ozogamicin, avelumab,
duvalumab, and emicizumab. Brodalumab, however, had already been approved in
Japan in 2016. As of December 1, 2017, nine antibody therapeutics (ibalizumab,
burosumab, tildrakizumab, caplacizumab, erenumab, fremanezumab, galcanezumab,
romosozumab, mogamulizumab) were in regulatory review in the EU or US, and
regulatory actions on their marketing applications are expected by the end of
2018. Based on company announcements and estimated clinical study primary
completion dates, and assuming the study results are positive, marketing
applications for at least 12 antibody therapeutics that are now being evaluated
in late-stage clinical studies may be submitted by the end of 2018. Of the 12
candidates, 8 are for non-cancer indications (lanadelumab, crizanlizumab,
ravulizumab, eptinezumab, risankizumab, satralizumab, brolucizumab, PRO140) and 4
are for cancer (sacituzumab govitecan, moxetumomab pasudotox, cemiplimab,
ublituximab). Additional antibody therapeutics to watch in 2018 include 19 mAbs
undergoing evaluation in late-stage studies with primary completion dates in late
2017 or during 2018. Of these mAbs, 9 are for non-cancer indications
(lampalizumab, roledumab, emapalumab, fasinumab, tanezumab, etrolizumab, NEOD001,
gantenerumab, anifrolumab) and 10 are for cancer indications (tremelimumab,
isatuximab, BCD-100, carotuximab, camrelizumab, IBI308, glembatumumab vedotin,
mirvetuximab soravtansine, oportuzumab monatox, L19IL2/L19TNF). Positive clinical
study results may enable marketing application submissions in 2018. Brief
summaries of these antibody therapeutics are provided in this installment of the
'Antibodies to watch' article series.
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