Roche submits supplemental biologics license application to US FDA for Kadcyla for adjuvant treatment of people with HER2-pos...
05 Fevereiro 2019 - 04:00AM
F. Hoffmann-La Roche Ltd / Roche submits supplemental biologics
license application to US FDA for Kadcyla for adjuvant treatment of
people with HER2-positive early breast cancer with residual disease
after neoadjuvant treatment . Processed and transmitted by West
Corporation. The issuer is solely responsible for the content of
this announcement.
Basel, 05 February 2019 - Roche (SIX: RO, ROG;
OTCQX: RHHBY) today announced completing the submission of a
supplemental Biologics License Application to the US Food and Drug
Administration (FDA) for Kadcyla® (trastuzumab emtansine) for
adjuvant (after surgery) treatment of people with HER2-positive
early breast cancer (eBC) with residual disease after neoadjuvant
(before surgery) treatment. The FDA is reviewing the application
under the Real-Time Oncology Review and Assessment Aid pilot
programmes, which aim to explore a more efficient review process to
ensure safe and effective treatments are available to patients as
early as possible. [1,2] For this indication, Kadcyla was also
granted Breakthrough Therapy Designation, which is designed to
expedite the development and review of medicines intended to treat
serious or life-threatening diseases. [3]
"Kadcyla was granted Breakthrough Therapy Designation and is also
the first Roche medicine to be reviewed under the FDA's Real-Time
Oncology Review pilot programme; both FDA initiatives aim to
expedite reviews and bring medicines to patients sooner" said
Sandra Horning, MD, Roche's Chief Medical Officer and Head of
Global Product Development. "We are working closely with the FDA to
bring Kadcyla to people with HER2-positive early breast cancer who
have residual disease after neoadjuvant therapy as early as
possible."
This application is based on results of the phase III KATHERINE
study showing Kadcyla significantly reduced the risk of invasive
breast cancer recurrence or death from any cause (invasive
disease-free survival; iDFS) by 50% (HR=0.50, 95% CI 0.39-0.64,
p<0.0001) compared to Herceptin® (trastuzumab) as an adjuvant
treatment in people with HER2-positive eBC who have residual
disease present following neoadjuvant treatment. [4] People who
have residual disease after neoadjuvant treatment have a worse
prognosis than those with no detectable disease. At three years,
88.3% of people treated with Kadcyla did not have their breast
cancer return compared to 77.0% treated with Herceptin, an absolute
improvement of 11.3%.[4]
The most common Grade 3-4 side effects (>1%) with Kadcyla in the
KATHERINE study were decreased platelet count; high blood pressure;
radiation-induced skin injury; numbness, tingling or pain in the
hands or feet; decreased neutrophil count; low blood potassium
level; fatigue and decrease in red blood cells. [4]
About the KATHERINE study [5]
KATHERINE is an international, multi-centre, two-arm,
randomised, open-label, phase III study evaluating the efficacy and
safety of Kadcyla versus Herceptin as an adjuvant therapy in people
with HER2-positive eBC who have pathological invasive residual
disease in the breast and/or axillary lymph nodes following
neoadjuvant therapy that included Herceptin and taxane-based
chemotherapy. The primary endpoint of the study is iDFS, which in
this study is defined as the time from randomisation free from
invasive breast cancer recurrence or death from any cause.
Secondary endpoints include disease-free survival and overall
survival.
About Kadcyla
Kadcyla is an
antibody-drug conjugate (ADC) engineered to deliver potent
chemotherapy directly to HER2-positive cancer cells, potentially
limiting damage to healthy tissues. [6, 7] It combines two
anti-cancer properties joined together by a stable linker: the
HER2-targeting properties of trastuzumab (the active ingredient in
Herceptin) and the chemotherapy agent DM1. [8] Kadcyla is the only
ADC approved as a single agent in 104 countries including the US
and EU for the treatment of people with HER2-positive metastatic
breast cancer who have previously received Herceptin and taxane
chemotherapy, separately or in combination. Roche licenses
technology for Kadcyla under an agreement with ImmunoGen,
Inc.
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. [9] 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. Real-Time Oncology Review Pilot Program.
[Internet; cited 1 February 2019]. Available from:
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OCE/ucm612927.htm.
[2] US Food and Drug Administration. Assessment Aid Pilot Project.
[Internet; cited 1 February 2019]. Available from:
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OCE/ucm612923.htm.
[3] US Food and Drug Administration. Breakthrough Therapy.
[Internet; cited 1 February 2019]. Available from:
https://www.fda.gov/ForPatients/Approvals/Fast/ucm405397.htm.
[4] Minckwitz G, et al. N Engl J Med.
2018;DOI:10.1056/NEJMoa1814017.
[5] ClinicalTrials.gov. A Study of Trastuzumab Emtansine Versus
Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive
Breast Cancer Who Have Residual Tumor in the Breast or Axillary
Lymph Nodes Following Preoperative Therapy (KATHERINE). [Internet;
cited 1 February 2019]. Available from:
https://clinicaltrials.gov/ct2/show/NCT01772472.
[6] Hurvitz SA, et al. J Clin Oncol. 2013;31(9):1157-63.
[7] Verma S, et al. N Engl J Med. 2012;367(19):1783-91.
[8] Junttila TT, et al. Breast Cancer Res Treat.
2011;128:347-56.
[9] 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
Roche-Media-Release-KATHERINE_FDA_submission_EN
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Source: F. Hoffmann-La Roche Ltd via Globenewswire
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