– Approval based on Phase III ALINA study
showing Alecensa reduced the risk of disease recurrence or death by
an unprecedented 76% in people with ALK-positive early-stage
resected non-small cell lung cancer (NSCLC) –
– This approval helps address an urgent unmet
need, with about half of people living with early-stage NSCLC
experiencing disease recurrence following surgery, despite adjuvant
chemotherapy –
– The National Comprehensive Cancer Network®
(NCCN®) Guidelines recommend routine testing for ALK, EGFR and
PD-L1 biomarkers in people with early-stage NSCLC to inform
adjuvant therapy selection –
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:
RHHBY), announced today that the U.S. Food and Drug Administration
(FDA) has approved Alecensa® (alectinib) for adjuvant treatment
following tumor resection for patients with anaplastic lymphoma
kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥
4 cm or node positive), as detected by an FDA-approved test.
Alecensa is now the first and only ALK inhibitor approved for
people with ALK-positive early-stage NSCLC who have undergone
surgery to remove their tumor.
“With an unprecedented 76% reduction in the risk of disease
recurrence or death versus chemotherapy, Alecensa significantly
improves upon the standard of care for people with early-stage
ALK-positive lung cancer,” said Levi Garraway, M.D., Ph.D., chief
medical officer and head of Global Product Development. “At
Genentech, our goal is to give patients the best chance of cure by
bringing effective, targeted treatments to early-stage disease
before their cancer has spread. This approval brings us one step
closer to achieving that mission.”
“The approval of Alecensa marks a pivotal moment for people
newly diagnosed with early-stage ALK-positive lung cancer, who
until now, were not able to receive ALK-specific therapy,” said Ken
Culver, Director of Research and Clinical Affairs at ALK Positive,
Inc. “These patients, who are typically diagnosed at a younger age,
often face recurrence and have a higher risk of developing brain
metastases than those with other types of NSCLC. Now, with this
significant advance, it is more important than ever that all people
diagnosed with early-stage lung cancer undergo testing for ALK and
other recommended biomarkers to receive the treatment most
appropriate for them.”
The approval is based on positive results from the Phase III
ALINA study that demonstrated Alecensa reduced the risk of disease
recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI:
0.13-0.43, p<0.0001) compared with platinum-based chemotherapy
in people with completely resected IB (tumor ≥ 4 cm) to IIIA
(UICC/AJCC 7th edition) ALK-positive NSCLC. In an exploratory
analysis, an improvement of central nervous system
(CNS)-disease-free survival (DFS) was observed (HR=0.22; 95% CI:
0.08-0.58). The safety and tolerability of Alecensa in this trial
were generally consistent with previous trials in the metastatic
setting and no unexpected safety findings were observed. These data
were presented as a late-breaking oral at the European Society of
Medical Oncology Congress 2023 Presidential Symposium in October
2023 and were also recently published in the New England Journal of
Medicine in April 2024.
Alecensa is a kinase inhibitor currently approved as first- and
second-line treatment for ALK-positive metastatic NSCLC. It has
demonstrated significant efficacy in patients, including those with
CNS metastases, and now with this approval, these benefits could
extend to people with early-stage disease. Routine testing of
resected surgical tissue or biopsy for ALK, EGFR and PD-L1
biomarkers in patients with stage IB to IIIA and select IIIB
(UICC/AJCC 8th edition) NSCLC, in addition to in the advanced
setting, is recommended by international guidelines, including the
National Comprehensive Cancer Network® (NCCN®) Clinical Practice
Guidelines in Oncology (NCCN Guidelines®), to support clinicians’
decision-making. About 5% of people with NSCLC are
ALK-positive.
The review of this application was conducted under the FDA’s
Project Orbis initiative, which provides a framework for concurrent
submission and review of oncology medicines among international
partners. According to the FDA, collaboration among international
regulators may allow patients with cancer to receive earlier access
to products in other countries where there may be significant
delays in regulatory submissions. For this review, FDA collaborated
with the Australian Therapeutics Goods Administration (TGA), Health
Canada (HC), Israel's Ministry of Health (IMoH) Pharmaceutical
Administration, Switzerland’s Swissmedic, and the United Kingdom’s
Medicines and Healthcare Products Regulatory Agency (UK MHRA).
Brazil's National Health Surveillance Agency (ANVISA) and
Singapore’s Health Sciences Authority (HSA) will also be
participating as Type C Project Orbis Partners. Additionally, the
FDA reviewed and approved the supplemental application under its
Real-Time Oncology Review pilot program, which aims to explore a
more efficient review process to ensure safe and effective
treatments are available to patients as early as possible. Data
from the Phase III ALINA study will also be used for filing
submissions to additional global health authorities, including the
European Medicines Agency.
About the ALINA study
The ALINA study [NCT03456076] is a Phase III, randomized,
active-controlled, multicenter, open-label study evaluating the
efficacy and safety of adjuvant Alecensa® (alectinib) compared with
platinum-based chemotherapy in people with resected Stage IB (tumor
≥ 4 cm) to IIIA (UICC/AJCC 7th edition) anaplastic lymphoma kinase
(ALK)-positive non-small cell lung cancer (NSCLC). The study
included 257 patients who were randomly assigned to either the
Alecensa or chemotherapy treatment arm. The primary endpoint is
disease-free survival (DFS). Secondary outcome measures include
overall survival (OS), central nervous system-DFS, and percentage
of patients with adverse events.
About lung cancer
According to the American Cancer Society, it is estimated that
more than 238,000 Americans will be diagnosed with lung cancer in
2023, and NSCLC accounts for 80-85% of all lung cancers. Treating
lung cancer early, before it has spread, may help prevent the
disease from returning and provide people with the best opportunity
for a cure. Approximately five percent of people with NSCLC are ALK
positive. ALK-positive NSCLC is often found in younger people –
usually 55 and under. Today, about half of all people with early
lung cancer (45-76%, depending on disease stage) still experience a
cancer recurrence following surgery, despite adjuvant
chemotherapy.
About Alecensa® (alectinib)
Alecensa is a prescription medicine used to treat people with
non-small cell lung cancer (NSCLC) that is caused by an abnormal
anaplastic lymphoma kinase (ALK) gene. It can be used to help
prevent lung cancer from coming back in patients after their tumor
has been removed by surgery (adjuvant), or to treat patients when
their lung cancer has spread to other parts of the body
(metastatic).
A doctor will perform a test to make sure that Alecensa is right
for their patient. It is not known if Alecensa is safe and
effective in children.
Important Safety Information
Everyone reacts differently to treatment with Alecensa. It’s
important to know the most serious and most common side effects
with Alecensa.
A doctor may lower the dose or stop treatment with Alecensa if
any side effects occur. Patients taking Alecensa should contact
their doctor right away if they have any of the following side
effects.
Alecensa may cause serious side effects, including:
Liver problems (hepatotoxicity). Liver problems are
common with Alecensa and can be severe. A doctor will do blood
tests at least every 2 weeks for the first 3 months, and then 1
time each month and as needed during treatment with Alecensa.
Patients taking Alecensa should tell their doctor right away if
they experience any of the following signs and symptoms:
- Feeling tired
- Feeling less hungry than usual
- Yellowing of the skin or whites of the eyes
- Dark urine
- Itchy skin
- Nausea or vomiting
- Pain on the right side of stomach area
- Bleeding or bruising more easily than normal
Lung problems. Alecensa may cause severe or
life-threatening swelling (inflammation) of the lungs during
treatment. Symptoms may be similar to those symptoms from lung
cancer. Patients taking Alecensa should tell their doctor right
away if they have any new or worsening symptoms, including trouble
breathing, shortness of breath, cough, or fever.
Kidney problems. Alecensa may cause severe kidney
problems that can lead to death. Patients should tell their doctor
right away if they have a change in the amount or color of their
urine, or if they get new or worsening swelling in their legs or
feet.
Slow heartbeat (bradycardia). Alecensa may cause very
slow heartbeats that can be severe. A doctor will check a patient’s
heart rate and blood pressure during treatment with Alecensa.
Patients taking Alecensa should tell their doctor right away if
they feel dizzy, lightheaded, or if they faint during treatment
with Alecensa. Patients taking Alecensa should tell their doctor if
they take any heart or blood pressure medicines.
Severe muscle pain, tenderness, and weakness (myalgia).
Muscle problems are common with Alecensa and can be severe. A
doctor will do blood tests at least every 2 weeks for the first
month and as needed during treatment with Alecensa. Patients taking
Alecensa should tell their doctor right away if they have any new
or worsening signs and symptoms of muscle problems, including
unexplained muscle pain or muscle pain that does not go away,
tenderness, or weakness.
Breakdown of healthy red blood cells earlier than normal
(hemolytic anemia). Hemolytic anemia can happen in some people
who take Alecensa. If this happens, patients may not have enough
healthy red blood cells. A doctor may temporarily stop Alecensa and
do blood tests, if needed, to check for this problem. If patients
develop hemolytic anemia, their doctor may either restart them on
Alecensa at a lower dose when the hemolytic anemia goes away, or
may stop treatment with Alecensa. Patients should tell their doctor
right away if they experience yellow skin (jaundice), weakness or
dizziness, or shortness of breath.
Before taking Alecensa, patients should tell their doctor
about all medical conditions, including if they:
- have liver problems
- have lung or breathing problems
- have a slow heartbeat
- are pregnant or plan to become pregnant. Alecensa can harm an
unborn baby.
- Females who are able to become pregnant will be tested
by their doctor to see if they are pregnant before starting
treatment with Alecensa. They should use effective birth control
(contraception) during treatment with Alecensa and for 5 weeks
after the last dose of Alecensa. Patients taking Alecensa should
tell their doctor right away if they become pregnant during
treatment with Alecensa or think they may be pregnant
- Males who have female partners that are able to become
pregnant should use effective birth control (contraception) during
treatment with Alecensa and for 3 months after the last dose of
Alecensa
- are breastfeeding or plan to breastfeed. It is not known if
Alecensa passes into breast milk. A patient should not breastfeed
during treatment with Alecensa and for 1 week after the last dose
of Alecensa. Patients should talk with their doctor about the best
way to feed their baby during this time.
Patients taking Alecensa should tell their doctor about all
the medicines they take, including prescription medicines,
over-the-counter medicines, vitamins, and herbal supplements.
Patients taking Alecensa should avoid spending time in the
sunlight during treatment with Alecensa and for 7 days after the
last dose of Alecensa. Patients taking Alecensa may be sensitive to
the sun (photosensitivity), burn more easily and get severe
sunburns. Patients taking Alecensa should use sunscreen and lip
balm with an SPF 50 or greater to help protect against sunburn.
The most common side effects of Alecensa include:
- constipation
- tiredness
- swelling in hands, feet, ankles, face, and eyelids
- rash
- cough
These are not all of the possible side effects of Alecensa. For
more information, patients should ask their doctor or pharmacist.
Patients should call their doctor for medical advice about side
effects.
Report side effects to the FDA at (800) FDA-1088 or
http://www.fda.gov/medwatch. Patients and caregivers may also
report side effects to Genentech at (888) 835-2555.
Please see additional Important Safety Information in
full Prescribing Information, including
Patient Information.
About Genentech in lung cancer
Lung cancer is a major area of focus and investment for
Genentech, and we are committed to developing new approaches,
medicines and tests that can help people with this deadly disease.
Our goal is to provide an effective treatment option for every
person diagnosed with lung cancer. We currently have six approved
medicines to treat certain kinds of lung cancer and more than 10
medicines being developed to target the most common genetic drivers
of lung cancer or to boost the immune system to combat the disease.
Genentech is committed to improving treatment of early-stage lung
cancers to help increase the chance of cure for more people.
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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