Pfizer Inc. (NYSE:PFE) today announced that the European
Commission has approved MYLOTARG™ (gemtuzumab ozogamicin) in
combination with daunorubicin and cytarabine for the treatment of
patients age 15 years and above with previously untreated, de novo,
CD33-positive acute myeloid leukemia (AML), except acute
promyelocytic leukemia (APL). MYLOTARG is the first and only AML
therapy approved in the European Union (EU) that targets CD33, an
antigen expressed on AML cells in up to 90% of patients.1,2,3
“The marketing authorization of MYLOTARG provides a much-needed
treatment option offering renewed hope for many acute myeloid
leukemia patients in Europe,” said Andreas Penk, M.D., regional
president, Pfizer Oncology. “In clinical trials, the addition of
MYLOTARG to standard chemotherapy resulted in deeper, more durable
remission, thus providing an additional treatment option with the
potential to prevent relapse for these patients.”
AML is a rapidly progressing, life-threatening blood and bone
marrow cancer.4 If left untreated, patients with AML will die
within months, if not weeks, of their disease. AML is the most
common type of acute leukemia in adults and accounts for
approximately 80% of all cases of acute leukemia.5 About 16,800
people are expected to be newly diagnosed with AML in Europe
annually.6 The goal of AML treatment is for the patient to achieve
a complete, prolonged remission. Longer periods of remission prior
to relapse are associated with better long-term outcomes for
patients. Thus, medicines that delay the time until the disease
comes back and extend life can provide meaningful clinical
benefit.
“I am thrilled that MYLOTARG will be available soon in Europe as
a first-line treatment for patients with acute myeloid leukemia,”
said Doctor Sylvie Castaigne, Professeur des Universités,
Université de Versailles - Saint Quentin, Praticien Hospitalier,
Centre Hospitalier de Versailles, and lead investigator of the
ALFA-0701 study. “This important milestone is a result of close
collaboration between Pfizer and clinical investigators around the
world, particularly the ALFA investigators in France, who believed
in the promise of this therapy. We thank all of the investigators,
nurses and patients who participated in these studies.”
The European Commission’s approval of MYLOTARG was based on data
from an investigator-led, Phase 3 randomized, open-label study
(ALFA-0701) in previously untreated, de novo patients. MYLOTARG
received approval by the U.S. Food and Drug Administration in
September 2017 for adults with newly diagnosed CD33-positive acute
myeloid leukemia (AML), and adults and children 2 years and older
with relapsed or refractory CD33-positive AML.
Pfizer is advancing a broad range of therapies that leverage
multiple pathways and mechanisms of action (MOAs) to address acute
and chronic leukemias, myeloproliferative disorders and lymphomas.
Pfizer currently has four marketed therapies for hematologic
cancers worldwide as well as several therapies in clinical
development. Pfizer is also forging collaborations with a diversity
of industry, academic and community partners to study multiple
paths to advancing treatment. By working together, Pfizer and its
partners aim to overcome the challenges of hematologic cancers and
deliver meaningful benefits to patients.
Indication for MYLOTARG ™ (gemtuzumab ozogamicin) in the
EU
MYLOTARG is approved in combination with daunorubicin and
cytarabine for the treatment of patients age 15 and above with
previously untreated, de novo, CD33-positive acute myeloid leukemia
(AML), except acute promyelocytic leukemia (APL).
IMPORTANT MYLOTARG™ (gemtuzumab ozogamicin) SAFETY
INFORMATION in the EU
The overall safety profile of MYLOTARG is based on data from
patients with acute myeloid leukemia from the combination therapy
study ALFA-0701, monotherapy studies, and from post-marketing
experience.
Hepatotoxicity, including life-threatening, and sometimes fatal
hepatic failure and VOD/SOS have been reported in patients treated
with MYLOTARG. Other special warnings and precautions include
myelosuppression and infusion-related reactions.
In the combination therapy study ALFA-0701, clinically relevant
serious adverse reactions were hepatotoxicity, including VOD/SOS
(3.8%), hemorrhage (9.9%), severe infection (41.2%), and tumour
lysis syndrome (1.5%). In monotherapy studies, clinically relevant
serious adverse reactions also included infusion related reactions
(2.5%), thrombocytopenia (21.7%), and neutropenia (34.3%).
The most common adverse reactions (> 30%) in the combination
therapy study were hemorrhage and infection. In monotherapy studies
the most common adverse reactions (> 30%) included pyrexia,
nausea, infection, chills, hemorrhage, vomiting, thrombocytopenia,
fatigue, headache, stomatitis, diarrhea, abdominal pain, and
neutropenia.
The most frequent (≥ 1%) adverse reactions that led to permanent
discontinuation in the combination therapy study were
thrombocytopenia, VOD, hemorrhage and infection. The most frequent
(≥ 1%) adverse reactions that led to permanent discontinuation in
monotherapy studies were infection, hemorrhage, multi-organ
failure, and VOD.
The EU Summary of Product Characteristics (SmPC) will be
available at http://www.ema.europa.eu.
About MYLOTARG™ (gemtuzumab ozogamicin)
MYLOTARG is an antibody-drug conjugate (ADC) composed of the
cytotoxic agent calicheamicin, attached to a monoclonal antibody
(mAB) targeting CD33, an antigen expressed on the surface of
myeloblasts in up to 90 percent of AML patients.1,2,3 When MYLOTARG
binds to the CD33 antigen on the cell surface it is absorbed into
the cell and calicheamicin is released causing cell death.2,3
MYLOTARG was approved by the U.S. Food and Drug Administration
in September 2017 for adults with newly diagnosed CD33-positive
acute myeloid leukemia (AML), and adults and children 2 years and
older with relapsed or refractory CD33-positive AML.
MYLOTARG originates from a collaboration between Pfizer and
Celltech, now UCB. Pfizer has sole responsibility for all
manufacturing, clinical development and commercialization
activities for this molecule.
Pfizer also collaborated with SFJ Pharmaceuticals Group on the
registrational program for MYLOTARG.
About Pfizer Oncology
Pfizer Oncology is committed to pursuing innovative treatments
that have a meaningful impact on people living with cancer. Our
growing pipeline of biologics, small molecules, and immunotherapies
is focused on identifying and translating the best scientific
breakthroughs into clinical application for patients across a
diverse array of solid tumors and hematologic cancers. Today, we
have 10 approved oncology medicines and 17 assets currently in
clinical development. By maximizing our internal scientific
resources and collaborating with other companies, government and
academic institutions, as well as non-profit and professional
organizations, we are bringing together the brightest and most
enterprising minds to take on the toughest cancers. Together we can
accelerate breakthrough treatments to patients around the world and
work to redefine life with cancer.
Pfizer Inc: Working together for a healthier world™
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best‐known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, we have worked to make a difference for
all who rely on us. We routinely post information that may be
important to investors on our website at www.pfizer.com. In
addition, to learn more, please visit us on www.pfizer.com and
follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube
and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is
as of April 23, 2018. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result
of new information or future events or developments.
This release contains forward-looking information about MYLOTARG
(gemtuzumab ozogamicin), an antibody-drug conjugate, and Pfizer’s
oncology portfolio, including their potential benefits, that
involve substantial risks and uncertainties that could cause actual
results to differ materially from those expressed or implied by
such statements. Risks and uncertainties include, among other
things, uncertainties regarding the commercial success of MYLOTARG;
the uncertainties inherent in research and development, including
the ability to meet anticipated clinical trial commencement and
completion dates and regulatory submission dates, as well as the
possibility of unfavorable clinical trial results, including
unfavorable new clinical data and additional analyses of existing
clinical data; whether and when applications for MYLOTARG may be
filed in any other jurisdictions and whether and when applications
for any other oncology products may be filed in any jurisdictions;
whether and when any such applications for MYLOTARG or any such
other oncology products that may be pending or filed may be
approved by regulatory authorities, which will depend on the
assessment by such regulatory authorities of the benefit-risk
profile suggested by the totality of the efficacy and safety
information submitted, and, if approved, whether such products will
be commercially successful; decisions by regulatory authorities
regarding labeling and other matters that could affect the
availability or commercial potential of MYLOTARG or any such other
oncology products; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2017 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
_________________________________1 Griffin JD, Linch D, Sabbath
K, et al: A monoclonal antibody reactive with normal and leukemic
human myeloid progenitor cells. Leuk Res 8: 521-534, 1984
CrossRefMedline.2 Tanaka M, Kano Y, et al. The Cytotoxic Effects of
Gemtuzumab Ozogamicin (Mylotarg) in Combination with Conventional
Antileukemic Agents by Isobologram Analysis In Vitro. Anticancer
Research. 2009; 29: 4589-4596.3 O’Hear C, Heiber JF, Schubert I,
Fey G, Geiger TL. Anti-CD33 chimeric antigen receptor targeting of
acute myeloid leukemia. Haematologica. 2015;100(3):336-344.4
Orpha.net. The portal for rare diseases and orphan drugs. Accessed
December 2017.
http://www.orpha.net/consor4.01/www/cgi-bin/OC_Exp.php?lng=EN&Expert=5195
Leukemia & Lymphoma Society, Acute Myeloid Leukemia Booklet.
Developed 2011. Accessed July 2017.
https://www.lls.org/sites/default/files/file_assets/aml.pdf6
RARECARE. Surveillance of rare cancers in Europe. Available at:
http://dcnapp4.dcn.ed.ac.uk/rcnet/searchpage.aspx. Accessed March
14, 2018.
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Pfizer Inc.Media:Jessica Smith, 212-733-6213Lisa O’Neill,
+44-1737-331536orInvestors:Ryan Crowe, 212-733-8160
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