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Hospital Pharmacy 52(7)

Table 1. CAR T-Cell Therapies in Development.
Generic name

Sponsor

CAR target

Comments
Axicabtagene was granted a priority review and has a PDUFA date of 11/29/17.
In one trial of 101 NHL patients, 54% achieved complete response at 6
months. Kite estimates the manufacturing turn-around time to be 22 days.
An FDA subcommittee recommended approval of tisagenlecleucel in a 10-0
vote on 7/12/17, with a PDUFA date of 10/3/17. Novartis is estimating the
manufacturing turn-around time to be 22 days, which includes 10 to 12 days
for cell processing. In a 50-patient phase II trial, 82% of patients achieved a
complete response. In a 60-patient ALL trial, overall survival was 65% at 24
months.
Analysts estimate that JCAR017 may be available in mid-2018. Juno plans a
phase III trial in DLBCL patients in the second half of 2017. In a 44-patient
trial, 66% of patients had an objective response, and 50% achieved a complete
response.
Bluebird announced that interim results from a phase I trial showed that 15 of
15 patients with relapsed multiple myeloma achieved an objective response.
Legend announced that interim results from a phase I Chinese trial showed that
33 of 35 patients with relapsed multiple myeloma achieved clinical remission
within 2 months.

Axicabtagene

Kite Pharma

CD19

Tisagenlecleucel

Novartis
Pharmaceuticals

CD19

JCAR017

Juno Therapeutics

CD19

bb2121

bluebird bio

BCMA

LCAR-B38M

Nanjing Legend
Biotech

BCMA

Source. Information adapted from the Prescribe Right Pharmaceutical Pipeline Tracker database.8
Note. CAR = chimeric antigen receptor; CD19 = cluster of differentiation 19; PDUFA = Prescription Drug User Fee Act; NHL = non-Hodgkin lymphoma;
DLBCL = diffuse large B-cell lymphoma; FDA = Food and Drug Administration; ALL = acute lymphoblastic leukemia; BCMA = B-cell maturation antigen;
ORR = objective response rate.

of CAR T-cell products. These products will likely be
priced up to $500,000 per treatment course based on analyst predictions.6 An analysis by the United Kingdom's
National Institute for Health and Care Excellence suggested that these therapies could be worth up to $649,000
for young patients with acute lymphoblastic leukemia.7
The CRS side effect has generally been treated in clinical
trials with tocilizumab, which adds to the cost of this therapy. Tocilizumab costs about $1000 per dose. IVIG costs
between $1000 and $10,000 per dose.
Authors' Note
Information is summarized from selected materials; additional
information may be available from other sources. Due to the preapproval nature of the information, non-peer-reviewed data may be
utilized. The information provided is meant to provide a way to
assess the development status of a new drug and should not be used
in making patient care decisions.

Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with
respect to the research, authorship, and/or publication of this
article.

Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.

References
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6, 2017. Accessed July 9, 2017.
6. Clarke T. Pioneering cancer gene therapy by Novartis backed by
US panel. Reuters. http://www.reuters.com/article/us-novartiscancer-idUSKBN19X2OZ. Accessed July 24, 2017.
7. Hettle R, Corbett M, Hinde S, et al. The assessment and
appraisal of regenerative medicines and cell therapy products:
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prescriberight.com/pharmaceutical-pipeline-tracker.html.
Accessed July 24, 2017.

http://seer.cancer.gov/statfacts/html/nhl.html http://seer.cancer.gov/statfacts/html/nhl.html http://accesspharmacy.mhmedical.com/content.aspx?bookid=1861§ionid=133894009 http://accesspharmacy.mhmedical.com/content.aspx?bookid=1861§ionid=133894009 https://www.managedcaremag.com/archives/2017/5/chimeric-antigen-receptor-t-cell-therapy-next-big-thing-faces-challenges https://www.managedcaremag.com/archives/2017/5/chimeric-antigen-receptor-t-cell-therapy-next-big-thing-faces-challenges https://www.managedcaremag.com/archives/2017/5/chimeric-antigen-receptor-t-cell-therapy-next-big-thing-faces-challenges http://www.reuters.com/article/us-novartis- cancer-idUSKBN19X2OZ http://www.reuters.com/article/us-novartis- cancer-idUSKBN19X2OZ http://www.prescriberight.com/pharmaceutical-pipeline-tracker.html http://www.prescriberight.com/pharmaceutical-pipeline-tracker.html

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