– Approval based on data showing Kadcyla cut the risk of disease
recurring by half compared to Herceptin in the adjuvant setting for
specific patients with HER2-positive early breast cancer –
– Application approved under FDA’s Real-Time Oncology Review pilot
program –
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced that the U.S. Food and Drug Administration (FDA) has
approved Kadcyla® (ado-trastuzumab emtansine) for adjuvant
(after surgery) treatment of people with HER2-positive early breast
cancer (EBC) who have residual invasive disease after neoadjuvant
(before surgery) taxane and Herceptin® (trastuzumab)-based
treatment.
“This approval is a significant treatment advance for HER2-positive
early breast cancer. By working closely with the FDA and participating
in the Real-Time Oncology Review pilot program, we are able to make
Kadcyla available for people with residual invasive disease after
neoadjuvant therapy much sooner than anticipated,” said Sandra Horning,
M.D., chief medical officer and head of Global Product Development.
“With every step forward in reducing the risk of disease recurrence, we
come closer to the goal of helping each person with early breast cancer
have the greatest opportunity for cure.”
The goal in treating EBC is to provide people with the best chance for a
cure, which may involve treatment before and after surgery as part of a
comprehensive treatment approach. While we come closer to this goal with
each advance, many people still have a disease recurrence in the long
term. Neoadjuvant treatment is given before surgery with the goal of
shrinking tumors and helping to improve surgical outcomes. Adjuvant
treatment is given after surgery and aims to eliminate any remaining
cancer cells in the body to help reduce the risk of the cancer returning.
The FDA rapidly reviewed and approved the application under the FDA’s
Real-Time Oncology Review (RTOR) and Assessment Aid pilot programs,
leading to an approval 12 weeks after completing the submission. Kadcyla
is the first Genentech medicine approved under the RTOR pilot program,
which is exploring a more efficient review process to ensure safe and
effective treatments are available to patients as early as possible. 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.
This approval 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
as an adjuvant treatment in people with HER2-positive EBC who have
residual invasive disease after neoadjuvant taxane and Herceptin-based
treatment. 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%. People who have residual
disease after neoadjuvant treatment have a worse prognosis than those
with no detectable disease.
The most common Grade 3 or higher side effects (>2%) with Kadcyla in the
KATHERINE study were decreased platelet count and high blood pressure.
The most common side effects (>25%) with Kadcyla were fatigue; nausea;
increased blood levels of liver enzymes; musculoskeletal pain; bleeding;
decreased platelet count; headache; numbness, tingling or pain in the
hands or feet; and joint pain.
For those who qualify, Genentech offers patient assistance programs for
people prescribed Kadcyla by their doctor. Please contact Genentech
Access Solutions at (866) 422-2377 or visit http://www.Genentech-Access.com/Kadcyla
for more information.
About the KATHERINE study
KATHERINE is an international, multi-center, two-arm, randomized,
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
randomization free from invasive breast cancer recurrence or death from
any cause. Secondary endpoints include iDFS including second primary
non-breast cancer, disease-free survival and overall survival.
| KATHERINE Study Results | ||||||
|
Kadcyla |
Herceptin |
|||||
| Median follow-up | 40 months | |||||
| Invasive disease-free survival (iDFS) | ||||||
| Risk reduction | HR=0.50, 95% CI 0.39-0.64, p<0.0001 | |||||
| 3-year iDFS | 88.3% | 77.0% | ||||
| 11.3% absolute improvement | ||||||
| Adverse reactions (ARs) | ||||||
| Grade ≥3 AR | 26% | 15% | ||||
| Most common Grade ≥3 ARs (>2%) | ||||||
| Thrombocytopenia (decreased platelet count) | 6% | 0.3% | ||||
| Hypertension (high blood pressure) | 2.0% | 1.2% | ||||
About HER2-positive breast cancer
Breast cancer is one of the most common cancers among women worldwide.
According to the American Cancer Society, approximately 271,000 people
in the United States will be diagnosed with breast cancer, and more than
42,000 will die from the disease in 2019. Breast cancer is not one, but
many diseases based on the biology of each tumor. In HER2-positive
breast cancer, there is excess HER2 protein on the surface of tumor
cells. Approximately 15-20% of breast cancers are HER2-positive based on
the result of a diagnostic test.
About Kadcyla
Kadcyla is an antibody-drug conjugate (ADC) engineered to deliver potent
chemotherapy directly to HER2-positive cancer cells. It is designed to
limit damage to healthy tissues, although it can still affect them.
Kadcyla can cause serious side effects. It combines two anti-cancer
agents using a stable linker: the HER2-targeting trastuzumab (the active
ingredient in Herceptin) and the chemotherapy agent DM1. Kadcyla is the
only ADC approved for the treatment of HER2-positive early and
metastatic breast cancer. In the U.S., Genentech licenses technology for
Kadcyla under an agreement with ImmunoGen, Inc.
Kadcyla Indication Statements
Kadcyla is approved as an adjuvant (after surgery) treatment for
HER2-positive early breast cancer when the patient has taken neoadjuvant
(before surgery) treatment including a taxane and trastuzumab
(Herceptin) and there is cancer remaining in the tissue removed during
surgery. Patients are selected for therapy based on an FDA-approved test
for Kadcyla.
Kadcyla is approved to treat HER2-positive breast cancer that has spread
to other parts of the body (metastatic breast cancer) after prior
treatment with trastuzumab (Herceptin) and a taxane. Prior treatment
could have been for the initial treatment of breast cancer or for the
treatment of cancer that had spread to other parts of the body. Patients
are selected for therapy based on an FDA-approved test for Kadcyla.
Important Safety Information
Most important safety information about Kadcyla
Liver problems
-
- Kadcyla may cause severe liver problems that can be life-threatening.
Symptoms of liver problems may include vomiting, nausea, eating
disorder (anorexia), yellowing of the skin (jaundice), stomach pain,
dark urine, or itching.
- Kadcyla may cause severe liver problems that can be life-threatening.
Heart problems
-
- Kadcyla may cause heart problems, including those without symptoms
(such as reduced heart function) and those with symptoms (such as
congestive heart failure). Symptoms may include swelling of the ankles
or legs, shortness of breath, cough, rapid weight gain of more than
five pounds in 24 hours, dizziness or loss of consciousness, or
irregular heartbeat.
- Kadcyla may cause heart problems, including those without symptoms
Pregnancy
-
- Receiving Kadcyla during pregnancy can result in the death of an
unborn baby and birth defects. Birth control should be used while
receiving Kadcyla and for seven months after a patient’s last dose of
Kadcyla.
- Receiving Kadcyla during pregnancy can result in the death of an
-
- If a patient thinks she may be pregnant, she should contact her
healthcare provider immediately.
- If a patient thinks she may be pregnant, she should contact her
-
- If a patient is exposed to Kadcyla during pregnancy or becomes
pregnant within seven months following her last dose of Kadcyla, she
is encouraged to report Kadcyla exposure to Genentech by calling (888)
835-2555.
- If a patient is exposed to Kadcyla during pregnancy or becomes
-
- If a male patient has a female partner that could become pregnant,
birth control should be used during treatment and for four months
following his last dose of Kadcyla.
- If a male patient has a female partner that could become pregnant,
-
- A patient should not breastfeed during treatment and for seven months
after the last dose of Kadcyla.
- A patient should not breastfeed during treatment and for seven months
A patient should contact their doctor right away if they experience
symptoms associated with these side effects.
Additional possible serious side effects of Kadcyla
Lung problems
-
- Kadcyla may cause lung problems, including inflammation of the lung
tissue, which can be life-threatening. Signs of lung problems may
include trouble breathing, cough, tiredness, and fluid in the lungs.
- Kadcyla may cause lung problems, including inflammation of the lung
Infusion-related reactions
-
- Symptoms of an infusion-related reaction may include one or more of
the following: the skin getting hot or red (flushing), chills, fever,
trouble breathing, low blood pressure, wheezing, tightening of the
muscles in the chest around the airways, or a fast heartbeat. A
patient’s doctor will monitor the patient for infusion-related
reactions.
- Symptoms of an infusion-related reaction may include one or more of
Serious bleeding
-
- Kadcyla can cause life-threatening bleeding. Taking Kadcyla with other
medications used to thin the blood (antiplatelet) or prevent blood
clots (anticoagulation) can increase the risk of bleeding. A patient’s
doctor should provide additional monitoring if the patient is taking
one of these other drugs while on Kadcyla. Even when blood thinners
are not also being taken, life-threatening bleeding may occur with
Kadcyla.
- Kadcyla can cause life-threatening bleeding. Taking Kadcyla with other
Low platelet count
-
- Low platelet count may happen during treatment with Kadcyla. Platelets
help the blood to clot. Signs of low platelets may include easy
bruising, bleeding, and prolonged bleeding from cuts. In mild cases
there may not be any symptoms.
- Low platelet count may happen during treatment with Kadcyla. Platelets
Nerve damage
-
- Symptoms may include numbness and tingling, burning or sharp pain,
sensitivity to touch, lack of coordination, muscle weakness, or loss
of muscle function.
- Symptoms may include numbness and tingling, burning or sharp pain,
Skin reactions around the infusion site
-
- Kadcyla may leak from the vein or needle and cause reactions such as
redness, tenderness, skin irritation, or pain or swelling at the
infusion site. If this happens, it is more likely to happen within 24
hours of the infusion.
- Kadcyla may leak from the vein or needle and cause reactions such as
Most common side effects of Kadcyla
The most common side effects in people taking Kadcyla for early breast
cancer are:
-
- Tiredness
-
- Nausea
-
- Liver problems
-
- Pain that affects the bones, muscles, ligaments and tendons
-
- Bleeding
-
- Low platelet count
-
- Headache
-
- Weakness, numbness, and pain in the hands and feet
-
- Joint pain
The most common side effects seen in people taking Kadcyla for
metastatic breast cancer are:
-
- Tiredness
-
- Nausea
-
- Pain that affects the bones, muscles, ligaments and tendons
-
- Bleeding
-
- Low platelet count
-
- Headache
-
- Liver problems
-
- Constipation
-
- Nosebleeds
Patients are encouraged to report side effects to Genentech and the FDA.
Patients may contact Genentech by calling (888) 835-2555. Patients may
contact the FDA by visiting http://www.fda.gov/medwatch
or calling (800) FDA-1088.
Please click
here for Kadcyla full Prescribing Information, including Most
Important Safety Information, for additional Important Safety
Information.
About Genentech in breast cancer
Genentech has been advancing breast cancer research for more than 30
years with the goal of helping as many people with the disease as
possible. Our medicines, along with companion diagnostic tests, have
substantially improved outcomes for HER2-positive breast cancer. As our
understanding of breast cancer biology rapidly improves, we are working
to identify new biomarkers and approaches to treatment for other
subtypes of the disease, including triple-negative and hormone
receptor-positive.
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology
company that discovers, develops, manufactures and commercializes
medicines to treat patients with serious and life-threatening medical
conditions. The company, a member of the Roche Group, has headquarters
in South San Francisco, California. For additional information about the
company, please visit http://www.gene.com.
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Contacts
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(650) 467-6800
Advocacy Contact:
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(202) 258-8228
Investor Contacts:
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(650) 225-3217
Karl Mahler
011 41 61 687 8503