AstraZeneca today announced that the US Food and Drug
Administration (FDA) has approved a blood-based companion
diagnostic for TAGRISSO® (osimertinib). The companion diagnostic
for TAGRISSO is the only FDA-approved and clinically validated
companion diagnostic test that uses either tissue or a blood sample
to confirm the presence of a T790M mutation in patients with
metastatic epidermal growth factor receptor (EGFR)
mutation-positive non-small cell lung cancer (NSCLC), who have
progressed on or after an EGFR tyrosine kinase inhibitor (TKI)
medicine.
The approval provides a new, non-invasive option to identify
patients with metastatic EGFR T790M mutation-positive NSCLC,
ensuring that those patients who may not be suitable for biopsy
procedures have an opportunity to be tested. Blood-based testing
for the presence of the mutation is recommended only when a tumor
biopsy cannot be obtained. Patients who test negative for the T790M
mutation with the blood-based test, and their physicians, should
re-evaluate the feasibility of tissue-based testing to confirm the
presence of the EGFR T790M mutation.
The companion diagnostic, cobas® EGFR Mutation Test v2, was
developed by Roche Molecular Systems. The test enables
identification of patients who have the T790M mutation at disease
progression, and is initially available through Baystate Health,
Carolinas HealthCare System, Laboratory Corporation of America®
Holdings (LabCorp®), and PhenoPath.
“Blood-based testing has the potential to rapidly identify
patients eligible for targeted therapy, who may not be eligible for
biopsy. Availability of this blood-based test may help aid
treatment decisions,” said Balazs Halmos, MD, Montefiore Medical
Park, Albert Einstein College of Medicine.
“The availability of an FDA-approved, blood-based companion
diagnostic is a tremendous step forward for patients with lung
cancer in need of a high-quality test that provides results with a
rapid turnaround time. This development offers an important option
for the identification of the T790M mutation in patients with
metastatic EGFR mutation-positive NSCLC who have progressed on an
EGFR TKI medicine, for whom a tissue biopsy may not be feasible,”
said Andrew Coop, Vice President, US Medical Affairs, Oncology,
AstraZeneca. “Delivering targeted therapies, such as TAGRISSO, to
the right patients at the right time demonstrates our commitment to
testing and quality companion diagnostics.”
Nearly two-thirds of cases of progression with first-generation
EGFR TKIs are related to an acquired EGFR T790M mutation — for
which there have been limited treatment options in the past.
TAGRISSO is the only FDA-approved targeted medicine for the
treatment of patients with metastatic EGFR T790M mutation-positive
NSCLC who have progressed on or after an EGFR TKI medicine, and was
approved by the FDA in November 2015. This indication is approved
under accelerated approval based on tumor response rate and
duration of response. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
confirmatory trials.
The TAGRISSO tolerability profile showed that no individual
severe grade 3+ adverse events occurred at ≥ 3.5%. The most common
adverse events were generally mild to moderate and included
diarrhea (42% all grades; 1.0% grade 3/4), rash (41% all grades;
0.5% grade 3/4), dry skin (31% all grades; 0% grade 3/4), and nail
toxicity (25% all grades; 0% grade 3/4).
Important Safety Information About TAGRISSO®
(osimertinib)
- There are no contraindications for
TAGRISSO.
- Interstitial Lung Disease
(ILD)/Pneumonitis occurred in 3.3% and were fatal in 0.5% of 813
TAGRISSO patients. Withhold TAGRISSO and promptly investigate for
ILD in any patient presenting with worsening of respiratory
symptoms indicative of ILD (e.g., dyspnea, cough and fever).
Permanently discontinue TAGRISSO if ILD is confirmed
- QTc interval prolongation occurred in
TAGRISSO patients. Of the 411 patients in two Phase II studies,
0.2% were found to have a QTc greater than 500 msec, and 2.7% had
an increase from baseline QTc greater than 60 msec. Conduct
periodic monitoring with ECGs and electrolytes in patients with
congenital long QTc syndrome, congestive heart failure, electrolyte
abnormalities, or those who are taking medications known to prolong
the QTc interval. Permanently discontinue TAGRISSO in patients who
develop QTc interval prolongation with signs/symptoms of life
threatening arrhythmia
- Cardiomyopathy occurred in 1.4% and
were fatal in 0.2% of 813 TAGRISSO patients. Left Ventricular
Ejection Fraction (LVEF) decline >10% and a drop to <50%
occurred in 2.4% of (9/375) TAGRISSO patients. Assess LVEF before
initiation and then at 3 month intervals of treatment. Withhold
TAGRISSO if ejection fraction decreases by 10% from pretreatment
values and is less than 50%. For symptomatic congestive heart
failure or persistent asymptomatic LV dysfunction that does not
resolve within 4 weeks, permanently discontinue TAGRISSO.
- Advise pregnant women of the potential
risk to a fetus. Advise females of reproductive potential to use
effective contraception during TAGRISSO treatment and for 6 weeks
after the final dose. Advise males with female partners of
reproductive potential to use effective contraception for 4 months
after the final dose.
- The most common adverse reactions
(>20%) observed in TAGRISSO patients were diarrhea (42%), rash
(41%), dry skin (31%) and nail toxicity (25%).
TAGRISSO is indicated for the treatment of patients with
metastatic epidermal growth factor receptor (EGFR) T790M
mutation-positive non-small cell lung cancer (NSCLC), as detected
by an FDA-approved test, who have progressed on or after EGFR
tyrosine kinase inhibitor therapy.
This indication is approved under accelerated approval based on
tumor response rate and duration of response. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in confirmatory trials.
Please see accompanying complete Prescribing Information
including Patient Information.
NOTES TO EDITORS
About T790M Blood-Based Testing
Overall detection rates for the EGFR T790M mutation from plasma
and tissue samples are broadly concordant; differences in test
results can arise from biological (tumor heterogeneity and
differential shedding) and technical (assay methodology) factors. A
blood sample that tests negative for T790M mutation does not
necessarily mean a patient is ineligible for TAGRISSO, as a
positive result may still be obtained with tissue, if the patient
is eligible for biopsy. Blood-based testing for T790M has been
conducted in multiple studies, including in a cross-platform
comparison of leading technologies to support the clinical
development of TAGRISSO (Phase I/II AURA trials).
About Non-Small Cell Lung Cancer
Lung cancer is the leading cause of cancer death among both men
and women, accounting for about one-third of all cancer deaths —
more than breast, prostate and colorectal cancers combined. Lung
cancer has a five-year survival rate that is less than 20 percent.
Approximately 85 percent of all lung cancers in the US are NSCLC;
10 to 15 percent of these are EGFR mutation-positive. Approximately
two-thirds of patients treated with an EGFR TKI medicine will
acquire resistance related to the T790M mutation.
About TAGRISSO
TAGRISSO® (osimertinib) 80mg once-daily tablet is the first
medicine indicated for the treatment of metastatic epidermal growth
factor receptor (EGFR) T790M mutation-positive NSCLC, as detected
by an FDA-approved test, who have progressed on or after EGFR TKI
therapy.
About the TAGRISSO Development Program
TAGRISSO® (osimertinib) is being studied in the confirmatory
trial, AURA3, an open label, randomized Phase III study designed to
assess the efficacy and safety of TAGRISSO versus platinum-based
doublet chemotherapy in patients with EGFR T790M mutation-positive,
locally advanced or metastatic NSCLC who have progressed following
prior therapy with an EGFR TKI. TAGRISSO is also being investigated
in the adjuvant setting and in the metastatic first-line setting,
including in patients with brain metastases, as well as in
combination with other compounds.
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a
quickly growing portfolio of new medicines that has the potential
to transform patients’ lives and the Company’s future. With at
least six new medicines to be launched between 2014 and 2020 and a
broad pipeline of small molecules and biologics in development, we
are committed to advancing New Oncology as one of AstraZeneca’s six
Growth Platforms, focused on lung, ovarian, breast and blood
cancers. In addition to our core capabilities, we actively pursue
innovative partnerships and investments that accelerate the
delivery of our strategy, as illustrated by our investment in
Acerta Pharma in hematology.
By harnessing the power of four scientific platforms —
immuno-oncology, the genetic drivers of cancer and resistance, DNA
damage repair and antibody drug conjugates — and by championing the
development of personalized combinations, AstraZeneca has the
vision to redefine cancer treatment and one day eliminate cancer as
a cause of death.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialization of
prescription medicines, primarily for the treatment of diseases in
three therapy areas – Respiratory and Autoimmunity, Cardiovascular
and Metabolic Diseases, and Oncology. The company is also active in
inflammation, infection and neuroscience through numerous
collaborations. AstraZeneca operates in over 100 countries and its
innovative medicines are used by millions of patients worldwide.
For more information please visit: www.astrazeneca-us.com.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics
focused on advancing science to improve people’s lives.
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. The combined strengths of pharmaceuticals and
diagnostics under one roof have made Roche the leader in
personalized healthcare – a strategy that aims to fit the right
treatment to each patient in the best way possible.
Founded in 1896, Roche continues to search for better ways to
prevent, diagnose and treat diseases and make a sustainable
contribution to society. Twenty-nine 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. Roche has been recognized as
the Group Leader in sustainability within the Pharmaceuticals,
Biotechnology & Life Sciences Industry seven years in a row by
the Dow Jones Sustainability Indices.
The Roche Group, headquartered in Basel, Switzerland, is active
in over 100 countries and in 2015 employed more than 91,700 people
worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and
posted sales of CHF 48.1 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.
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