NEW YORK--(BUSINESS WIRE)--
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
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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=519
5
Leukemia & Lymphoma Society, Acute Myeloid Leukemia Booklet. Developed
2011. Accessed July 2017. https://www.lls.org/sites/default/files/file_assets/aml.pdf
6
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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Source: Pfizer Inc.