FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For
period ending 02 November
2017
GlaxoSmithKline plc
(Name
of registrant)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or
will
file annual reports under cover Form 20-F or Form 40-F
Form
20-F x Form 40-F
--
Indicate
by check mark whether the registrant by furnishing the
information
contained in this Form is also thereby furnishing the
information
to the Commission pursuant to Rule 12g3-2(b) under the
Securities
Exchange Act of 1934.
Yes
No x
Issued:
Thursday 2 November 2017, London UK - LSE Announcement
GSK's investigational BCMA antibody-drug conjugate receives
Breakthrough Therapy Designation from US FDA for relapsed and
refractory multiple myeloma
GlaxoSmithKline
plc (LSE/NYSE: GSK) today announced that it has received
Breakthrough Therapy Designation from the U.S. Food and Drug
Administration (FDA) for GSK2857916 monotherapy in patients with
multiple myeloma who have failed at least three prior lines of
therapy, including an anti-CD38 antibody and are refractory to a
proteasome inhibitor and an immunomodulatory agent. In October, the
European Medicines Agency (EMA) granted PRIME designation to
GSK2857916 for the treatment of relapsed and refractory multiple
myeloma patients whose prior therapy included a proteasome
inhibitor, an immunomodulatory agent and an anti-CD38
antibody. GSK2857916 is an anti B-cell maturation agent
(BCMA) monoclonal antibody-drug conjugate.
GSK2857916
has also received orphan drug designation from the EMA and FDA for
multiple myeloma.
The
PRIME and Breakthrough Therapy Designations are based on results
from a phase 1 open-label, dose escalation and expansion study in
patients with relapsed/refractory multiple myeloma, irrespective of
BCMA expression. Data from this ongoing trial will be presented on
11th
December in an oral presentation at the 59th annual meeting of
the American Society of Hematology meeting in Atlanta.
Axel
Hoos, SVP Oncology R&D, GSK said "Oncology R&D at GSK is
focussed on developing medicines with transformational potential
for patients and we are pleased that our investigational
antibody-drug conjugate is the first BCMA targeting agent to
receive Breakthrough Therapy and PRIME designation. GSK plans
to rapidly advance clinical trials with this promising therapy,
alone and in combination with other therapies, to further
investigate how GSK2857916 could benefit patients with multiple
myeloma. The monotherapy data that we have seen for GSK2857916
support its transformational potential and we look forward to
working with regulators as we progress the development
programme."
Notes to editors -
Breakthrough Therapy Designation is designed to expedite the development and
review of drugs that are intended to treat a serious condition and
preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement over available therapy on a
clinically significant endpoint(s). Drugs that receive breakthrough
therapy designation are eligible for all features of FDA's Fast
Track Programme.[i]
PRIME designation is offered
by the European Medicines Agency (EMA) to enhance support for the
development of medicines that target an unmet medical need. It is
based on enhanced interaction between sponsor companies and the EMA
to optimise development plans and speed up evaluation so these
medicines can reach patients earlier.[ii]
Orphan designation may be
granted for therapies intended to treat conditions that affect
fewer than 200,000 people in the U.S. The designation
qualifies the sponsor of the drug for various development
incentives of the Orphan Drug Act, including tax credits for
qualified clinical testing[iii].
In Europe, sponsors who obtain Orphan Designation for a potential
new medicine benefit from a range of incentives, including protocol
assistance, access to the centralised procedure, market exclusivity
and fee reductions.[iv]
About GSK2857916:
GSK2857916
is a humanised anti BCMA monoclonal antibody conjugated to the
cytotoxic agent monomethyl auristatin-F, via non-cleavable linker
(drug linker technology in-licensed from Seattle
Genetics).
GSK2857916
is currently in phase 1 clinical development (NCT02064387) in
patients with relapsed/refractory multiple myeloma and other
advanced haematologic malignancies expressing BCMA.
GSK2857916 is not approved for use anywhere in the
world.
GSK - one of the world's
leading research-based pharmaceutical and healthcare companies - is
committed to improving the quality of human life by enabling people
to do more, feel better and live longer. For further
information please visit www.gsk.com.
GSK enquiries:
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UK
Media enquiries:
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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David
Daley
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+44 (0)
20 8047 5502
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(London)
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US
Media enquiries:
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Sarah
Spencer
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+1 215
751 3335
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(Philadelphia)
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Mary
Anne Rhyne
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+1 919
483 0492
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(North
Carolina)
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Analyst/Investor
enquiries:
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Sarah
Elton-Farr
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+44 (0)
20 8047 5194
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(London)
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Tom
Curry
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+ 1 215
751 5419
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(Philadelphia)
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Gary
Davies
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+44 (0)
20 8047 5503
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Cautionary statement regarding forward-looking statementsGSK
cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item 3.D
'Principal risks and uncertainties' in the company's Annual Report
on Form 20-F for 2016.
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Registered in England & Wales:
No. 3888792
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Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
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[i] U.S. Food and Drug Administration Frequently Asked
Questions: Breakthrough therapies. Accessed October 2017. Available
at: https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/significantamendmentstothefdcact/fdasia/ucm341027.htm
[ii] European Medicines Agency PRIME: priority
medicines. Accessed October 2017. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000660.jsp
[iii] U.S. Food and Drug Administration Designating an
Orphan Product: Drugs and Biologic Products. Accessed October
2017. Available at: https://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/howtoapplyfororphanproductdesignation/default.htm
[iv] European Medicines Agency Orphan Designations.
Accessed October 2017. Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000029.jsp
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GlaxoSmithKline plc
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(Registrant)
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Date: November
02, 2017
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By: VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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