FDA Grants Genentech’s Alecensa® (Alectinib) Accelerated Approval for People with a Specific Type of Lung Cancer

Guía de Regalos

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
announced today that the U.S. Food and Drug Administration (FDA) granted
accelerated approval to Alecensa® (alectinib) for the
treatment of people with anaplastic lymphoma kinase (ALK)-positive,
metastatic non-small cell lung cancer (NSCLC) who have progressed on or
are intolerant to crizotinib. In the pivotal studies, Alecensa shrank
tumors in up to 44 percent of people with ALK-positive NSCLC who
progressed on crizotinib (objective response rate [ORR] of 38 percent
[95 percent CI 28-49] and 44 percent [95 percent CI 36-53]). In a subset
of people with tumors that spread to the brain or other parts of the
central nervous system (CNS), Alecensa shrank CNS tumors in about 60
percent of people (CNS ORR of 61 percent [95 percent CI 46-74]).

“Alecensa is now approved as a new option for people with ALK-positive
NSCLC who progress on or are intolerant to crizotinib,” said Sandra
Horning, M.D., chief medical officer and head of Global Product
Development. “Sixty percent of people enrolled in our studies had tumors
that had spread to their central nervous systems, and Alecensa shrank
tumors in many people in a subset of patients with CNS disease.”

Possible serious side effects with Alecensa include liver problems, lung
problems, slow heartbeat, muscle pain, tenderness and weakness. The most
common side effects of Alecensa include tiredness, constipation and
swelling in the hands, feet, ankles and eyelids.

The FDA’s Accelerated Approval Program allows conditional approval of a
medicine that fills an unmet medical need for a serious condition based
on early evidence suggesting clinical benefit. The indication for
Alecensa is approved under accelerated approval based on tumor response
rate and duration of response (DOR). Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in confirmatory trials.

Alecensa will be available to people in the United States within two
weeks. For those who qualify, Genentech plans to offer patient
assistance programs for people taking Alecensa through Genentech Access
Solutions. Doctors can contact Genentech Access Solutions at (888)
249-4918. More information is also available at http://www.Genentech-Access.com.

In addition, Alecensa is being studied for use as an initial
(first-line) treatment for people with advanced ALK-positive NSCLC. ALEX
is a global, randomized Phase III study comparing Alecensa to crizotinib
as an initial treatment for people with advanced NSCLC whose tumors were
characterized as ALK-positive by a companion VENTANA ALK (D5F3) CDx
Assay immunohistochemistry (IHC) test developed by Roche Diagnostics.
This study is part of the company’s commitment to convert the current
accelerated approval in people with ALK-positive, metastatic NSCLC who
have progressed on or are intolerant to crizotinib to a full approval as
an initial treatment.

About NP28761 (Study 1) and NP28673 (Study 2)

Study 1 is a Phase II North American, single-arm, open-label,
multicenter trial evaluating the safety and efficacy of Alecensa (600 mg
orally twice daily) in 87 people with ALK-positive NSCLC whose disease
progressed on crizotinib. Study 2 is a Phase I/II global, single-arm,
open-label, multicenter trial evaluating the safety and efficacy of
Alecensa (600 mg orally twice daily) in 138 people with ALK-positive
NSCLC whose disease progressed on crizotinib. People in the Phase II
studies received 600 mg of Alecensa orally twice daily. In both trials,
the primary endpoint was ORR according to Response Evaluation Criteria
in Solid Tumors (RECIST v1.1), as evaluated by an Independent Review
Committee (IRC). Secondary endpoints included DOR and efficacy against
disease that had spread to the CNS (CNS ORR and CNS DOR). A summary of
the efficacy and safety data from both studies that support this
approval is included below.

   

Efficacy
Parameter

Study 1 (North American)

n=87

  Study 2 (Global)

n=138

 

IRC*
Assessment

 

Investigator
Assessment

 

IRC*
Assessment

 

Investigator
Assessment

Objective Response Rate (ORR, primary endpoint)
ORR (%)

 

(95% CI)

  38

 

(28, 49)

  46

 

(35, 57)

  44

 

(36, 53)

  48

 

(39, 57)

Number of Responders

Number of
responders

  33   40   61   66

Duration of Response (DOR, secondary endpoint)

DOR (median in months)

 

(95% CI)

  7.5

 

(4.9, Not Estimable)

  NE

 

(4.9, Not Estimable)

  11.2

 

(9.6, Not Estimable)

  7.8

 

(7.4, 9.2)

CNS Efficacy (secondary endpoints, based on a pooled analysis of
51 people in Studies 1 and 2 with measurable CNS lesions at baseline
according to RECIST v1.1
a)
CNS ORR (%)

 

(95% CI)

  61

 

(46, 74)

CNS complete
response rate (%)

  18

CNS partial
response rate (%)

  43

CNS DOR (median
in months)

(95% CI)

 

9.1

(5.8, Not Evaluable)

*18 patients in Study 1 and 16 patients in Study 2 did not have
measurable disease at baseline as per IRC assessment and were classified
as non-responders in the IRC analysis.

aOf 51 people in the subgroup, 35 (69 percent) had
received prior brain radiation, including 25 (49 percent) who completed
radiation treatment at least 6 months before starting treatment with
Alecensa.

The most common Grade 3 or higher adverse events in the pooled analysis
of both studies were an increase in muscle enzymes (creatine
phosphokinase; 4.6 percent), shortness of breath (dyspnea; 3.6 percent),
increased liver enzymes (aspartate transaminase; 3.6 percent, and
alanine transaminase; 4.8 percent), evidence of liver dysfunction
(hyperbilirubinemia; 2.4 percent), increased blood glucose
(hyperglycemia; 2 percent), decreased levels of minerals (hypokalemia; 4
percent, hypophosphatemia; 2.8 percent, and hyponatremia; 2 percent),
decreased red blood cells (anemia; 2 percent) and decreased white blood
cells (lymphopenia; 4.6 percent).

About Lung Cancer

According to the American Cancer Society, it is estimated that more than
221,000 Americans will be diagnosed with lung cancer in 2015, and NSCLC
accounts for 85 percent of all lung cancers. It is estimated that
approximately 60 percent of lung cancer diagnoses in the United States
are made when the disease is in the advanced stages. Approximately 5
percent of people with NSCLC in the United States are ALK-positive.
ALK-positive NSCLC is often found in younger people who have a light or
non-smoking history.

About Genentech Access Solutions

Access Solutions is part of Genentech’s commitment to helping people
access the Genentech medicines they are prescribed, regardless of their
ability to pay. The team of 350 in-house specialists at Access Solutions
is dedicated to helping people navigate the access and reimbursement
process, and to providing assistance to eligible patients in the United
States who are uninsured or cannot afford the out-of-pocket costs for
their medicine. To date, the team has helped more than 1.2
million patients access the medicines they need. Please contact Access
Solutions (866) 4ACCESS/(866) 422-2377 or visit http://www.Genentech-Access.com for
more information.

About Alecensa

Alecensa is a kinase inhibitor approved for the treatment of people with
anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell
lung cancer (NSCLC) who have progressed on or are intolerant to
crizotinib.

This indication is approved under accelerated approval based on tumor
response rate and duration of response (DOR). Continued approval for
this indication may be contingent upon verification and description of
clinical benefit in confirmatory trials.

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
serious 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). Alecensa may cause liver injury.
A doctor will do blood tests at least every 2 weeks for the first 2
months 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
  • Fever
  • Cough

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 faint during treatment with Alecensa. Patients taking
Alecensa should tell their doctor if they take any heart or blood
pressure medicines.

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.

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. Patients taking Alecensa should tell their doctor right away if
    they become pregnant during treatment with Alecensa or think they may
    be pregnant

    • Women who are able to become pregnant should use effective
      birth control during treatment with Alecensa and for one week
      after the final dose of Alecensa
    • Men who have female partners that are able to become
      pregnant should use effective birth control during treatment with
      Alecensa and for three months after the final 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 one week after the final 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 seven days after the final dose
of Alecensa. Patients taking Alecensa may burn more easily and get
severe sunburns. Patients taking Alecensa should use sunscreen and lip
balm with a SPF 50 or greater to help protect against sunburn.

The most common side effects of Alecensa include:

  • Tiredness
  • Constipation
  • Swelling in hands, feet, ankles, and eyelids

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 three 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.

About Genentech

Founded more than 35 years ago, Genentech is a leading biotechnology
company that discovers, develops, manufactures and commercializes
medicines to treat patients with serious or 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.

Contacts

Genentech
Media Contact:
Andrew Villani, 650-467-6800
Advocacy
Contact:
Nicole Martin, 650-826-9223
Investor Contacts:
Stefan
Foser, 650-467-2016
Karl Mahler, 011 41 61 687 8503