Basel, 28 February 2019 - Roche (SIX: RO, ROG;
OTCQX: RHHBY) today announced that the US Food and Drug
Administration (FDA) has approved Herceptin Hylecta(TM)
(trastuzumab and hyaluronidase-oysk) for subcutaneous (under the
skin) injection for the treatment of certain people with
HER2-positive early breast cancer (node-positive, or node-negative
and ER/PR-negative or with one high-risk feature) in combination
with chemotherapy and HER2-positive metastatic breast cancer in
combination with paclitaxel or alone in people who have received
one or more chemotherapy regimens for metastatic
disease.1 This new
treatment includes the same monoclonal antibody as intravenous
Herceptin® (trastuzumab) in combination with recombinant human
hyaluronidase PH20, an enzyme that helps to deliver trastuzumab
under the skin. Herceptin Hylecta is a ready-to-use formulation
that can be administered in two to five minutes, compared to 30 to
90 minutes for intravenous Herceptin.2
"Over the past 20 years, Herceptin has significantly advanced
treatment of HER2-positive breast cancer," said Sandra Horning, MD,
Roche's Chief Medical Officer and Head of Global Product
Development. "The approval of Herceptin Hylecta gives physicians
and patients in the United States a new option to select treatment
based on individual needs and preferences."
The FDA approval is based on results from three clinical studies in
HER2-positive early breast cancer:1
-
The phase III HannaH study compared neoadjuvant
(before surgery) and adjuvant (after surgery) Herceptin Hylecta to
intravenous Herceptin, both in combination with chemotherapy.
Subcutaneous administration of Herceptin Hylecta resulted in
non-inferior levels of trastuzumab in the blood (pharmacokinetics)
and non-inferior clinical efficacy (pathological complete response
rate; pCR) compared to intravenous Herceptin.1
-
The phase III SafeHER study of adjuvant
Herceptin Hylecta identified no new safety signals, with safety and
tolerability consistent with the known safety profiles of
intravenous Herceptin and Herceptin Hylecta.1
-
The PrefHER patient preference study of adjuvant
Herceptin Hylecta followed by intravenous Herceptin, or the reverse
sequence, found the majority (86%) of people preferred Herceptin
Hylecta over intravenous Herceptin.1
The most common side effects in people receiving Herceptin Hylecta
for early breast cancer were feeling tired, joint pain, diarrhoea,
injection site reaction, upper respiratory tract infection, rash,
muscle pain, nausea, headache, swelling, flushing, fever, cough,
and pain in extremity.1
HannaH, SafeHER and PrefHER study
results1
HannaH |
|
Herceptin Hylecta |
Intravenous Herceptin |
pCR
(absence of invasive cancer cells in the breast) |
45.4%
(118/260)
95% CI 39.2%-51.7% |
40.7%
(107/263)
95% CI 34.7%-46.9% |
Mean
level of trastuzumab in the blood (Ctrough) before
dosing eighth cycle |
78.7
mcg/mL |
57.8
mcg/mL |
Geometric
mean ratio 1.3 (90% CI 1.2-1.4) |
Most
common adverse events (AEs; >=10%) |
Hair loss,
nausea, administration-related reactions, feeling tired, decreased
neutrophil count, diarrhoea, rash, upper respiratory tract
infection, vomiting, mouth blisters or sores, muscle pain,
decreased appetite, constipation, radiation skin injury, damage to
the nerves (numbness, tingling, pain in the hands/feet), joint
pain, flushing, fever, cough, low levels of red blood cells,
difficulty breathing, incision site pain, low levels of white blood
cells and mucosal inflammation |
SafeHER |
|
Herceptin Hylecta
n=1,864 |
Safety |
No new
safety signals for Herceptin Hylecta were identified. Safety and
tolerability were consistent with the known safety profiles of
intravenous Herceptin and Herceptin Hylecta |
Most
common AEs (>=10%) |
Administration-related reactions, feeling tired, diarrhoea,
injection site reaction,weakness, joint pain. rash, muscle pain,
nausea, damage to the nerves (numbness, tingling, pain in the
hands/feet), headache, swelling, flushing, fever, cough, and pain
in extremity |
PrefHER |
|
Herceptin Hylecta followed by intravenous Herceptin (n=121)
or intravenous Herceptin followed by Herceptin Hylecta
(n=119) |
Patient
preference |
86% of
people preferred Herceptin Hylecta, 13% preferred intravenous
Herceptin, 1% had no preference |
Reasons
for preference |
The most
common reason for preferring Herceptin Hylecta was time savings
(179/231). The most common reason for preferring intravenous
Herceptin was fewer local injection reactions |
About Herceptin
Hylecta
Herceptin
Hylecta (subcutaneous Herceptin) is a combination of trastuzumab
and Halozyme Therapeutics' Enhanze® drug delivery technology.
Trastuzumab is the same monoclonal antibody in intravenous
Herceptin that targets the HER2 receptor, a protein found on the
outside of many normal cells and in high quantities on the outside
of cancer cells in HER2-positive cancers.3 Herceptin is
designed to block HER2 signalling that is believed to play a role
in tumour growth and survival.4 Binding of
Herceptin to HER2 may also signal the body's immune system to
destroy the cancer cells.4 Halozyme's
Enhanze technology is based on a proprietary recombinant human
hyaluronidase PH20 (rHuPH20), an enzyme that temporarily degrades
hyaluronan, a glycosaminoglycan or chain of natural sugars in the
body, to aid in the dispersion and absorption of other injected
therapeutic drugs.
The subcutaneous formulation of Herceptin was first approved in
Europe in 2013 and is now approved in 100 countries
worldwide.
About Roche's medicines for
HER2-positive breast cancer
Roche has been leading research into the HER2 pathway
for over 30 years and is committed to improving the health, quality
of life and survival of people with both early and advanced
HER2-positive disease. HER2-positive breast cancer is a
particularly aggressive form of the disease that affects
approximately 15-20% of patients.5 Roche has
developed three innovative medicines that have helped transform the
treatment of HER2-positive breast cancer: Herceptin (trastuzumab),
Perjeta® (pertuzumab) and Kadcyla® (trastuzumab emtansine).
Eligibility for treatment with Roche's HER2-targeted medicines is
determined via a diagnostic test, which identifies people who will
likely benefit from these medicines at the onset of their
disease.
About Roche
Roche is a
global pioneer in pharmaceuticals and diagnostics focused on
advancing science to improve people's lives. The combined strengths
of pharmaceuticals and diagnostics under one roof have made Roche
the leader in personalised healthcare - a strategy that aims to fit
the right treatment to each patient in the best way
possible.
Roche is the world's largest biotech company, with truly
differentiated medicines in oncology, immunology, infectious
diseases, ophthalmology and diseases of the central nervous system.
Roche is also the world leader in in vitro diagnostics and
tissue-based cancer diagnostics, and a frontrunner in diabetes
management. Founded in 1896, Roche continues to search for better
ways to prevent, diagnose and treat diseases and make a sustainable
contribution to society. The company also aims to improve patient
access to medical innovations by working with all relevant
stakeholders. Thirty medicines developed by Roche are included in
the World Health Organization Model Lists of Essential Medicines,
among them life-saving antibiotics, antimalarials and cancer
medicines. Moreover, for the tenth consecutive year, Roche has been
recognised as the most sustainable company in the Pharmaceuticals
Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in
over 100 countries and in 2018 employed about 94,000 people
worldwide. In 2018, Roche invested CHF 11 billion in R&D and
posted sales of
CHF 56.8 billion. Genentech, in the United States, is a wholly
owned member of the Roche Group. Roche is the majority shareholder
in Chugai Pharmaceutical, Japan. For more information, please visit
www.roche.com.
All trademarks used or mentioned in this release are protected by
law.
References
[1] US Food and
Drug Administration Prescribing Information for Herceptin
Hylecta.
[2] European Medicines Agency. Summary of Product Characteristics
for Herceptin. [Internet; cited 2019 Feb 19]. Available from:
https://www.ema.europa.eu/documents/product-information/herceptin-epar-product-information_en.pdf
[3] Lewis Phillips G, et al. Cancer Res.
2008;68(22):9280-90.
[4] Gajria D, Chandarlapaty S. Expert Rev Anticancer Ther.
2011;11(2):263-75.
[5] Wolff AC, et al. J Clin Oncol. 2013;31(31):3997-4013.
Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail:
media.relations@roche.com
- Nicolas Dunant (Head)
- Patrick Barth
- Ulrike Engels-Lange
- Simone Oeschger
- Anja von Treskow
20190228-MR-FDA_approves_Herceptin_
Hylecta