Application Requests Approval for the Treatment
of Relapsed or Refractory Acute Lymphoblastic Leukemia in
Adults
Pfizer Inc. (NYSE:PFE) today announced that a Biologics License
Application (BLA) for inotuzumab ozogamicin has been accepted for
filing and granted Priority Review by the U.S. Food and Drug
Administration (FDA). Inotuzumab ozogamicin is being evaluated for
the treatment of adult patients with relapsed or refractory B-cell
precursor acute lymphoblastic leukemia (ALL).
Inotuzumab ozogamicin received Breakthrough Therapy designation
from the FDA in October 2015 for ALL. Priority Review status
accelerates FDA review time from 10 months to a goal of six months
from the day of acceptance of filing, and is given to drugs that
may offer major advances in treatment or may provide a treatment
for which no adequate therapy exists. The Prescription Drug User
Fee Act (PDUFA) goal date for a decision by the FDA is in August
2017.
“ALL that has recurred after, or is refractory to, first-line
therapy is a rapidly progressing and deadly disease,” said Mace
Rothenberg, MD, chief development officer, Oncology, Pfizer Global
Product Development. “Based on the positive results of the INO-VATE
1022 Phase 3 trial, we believe inotuzumab ozogamicin, if approved,
represents a new treatment option for adult patients with relapsed
or refractory B-cell precursor ALL.”
In addition, a Marketing Authorization Application (MAA) for
inotuzumab ozogamicin in the same patient population is currently
under review by the European Medicines Agency (EMA).
The submissions are based on results from the Phase 3 INO-VATE
1022 trial, which enrolled 326 adult patients with relapsed or
refractory B-cell ALL and compared inotuzumab ozogamicin to
standard of care chemotherapy. The INO-VATE 1022 study had two
independent primary endpoints, complete response with or without
hematologic remission (CR/CRi) and overall survival (OS). Results
from the trial were published in The New England Journal of
Medicine in June 2016.
About Acute Lymphoblastic Leukemia (ALL)
Acute lymphoblastic leukemia (ALL) is an aggressive type of
leukemia with a poor prognosis in adults.1 The current
foundational treatment is intensive, long-term chemotherapy.2 In
2017, it is estimated that 5,970 cases of ALL will be diagnosed in
the United States, with about 2 in 5 cases occurring in adults.3
Approximately 20 to 40 percent of newly diagnosed adults with ALL
are cured with current treatment regimens.4 For patients with
relapsed or refractory adult ALL, the five-year overall survival
rate is less than 10 percent.5
About Inotuzumab Ozogamicin
Inotuzumab ozogamicin is an investigational antibody-drug
conjugate (ADC) comprised of a monoclonal antibody (mAb) targeting
CD22, a cell surface antigen expressed on approximately 90
percent of B-cell malignancies, linked to a cytotoxic agent.6
When inotuzumab ozogamicin binds to the CD22 antigen on B-cells, it
is internalized into the cell, where the cytotoxic agent
calicheamicin is released to destroy the cell.7 The most common
adverse events (AEs) observed in clinical trials for inotuzumab
ozogamicin were cytopenias, including febrile neutropenia. Common
nonhematologic treatment-emergent AEs with inotuzumab ozogamicin
included nausea, headache and pyrexia. Additionally, veno-occlusive
liver disease (VOD) was observed more frequently in patients
treated with inotuzumab ozogamicin, especially those who went on to
receive hematopoietic stem cell transplantation.
Inotuzumab ozogamicin originates from a collaboration between
Pfizer and Celltech, now UCB. Pfizer has sole responsibility for
all manufacturing and clinical development activities for this
molecule.
About Pfizer Oncology
Pfizer Oncology is committed to pursuing innovative treatments
that have a meaningful impact on those living with cancer. As a
leader in oncology speeding cures and accessible breakthrough
medicines to patients, Pfizer Oncology is helping to redefine life
with cancer. Our strong pipeline of biologics, small molecules and
immunotherapies, one of the most robust in the industry, is studied
with precise focus on identifying and translating the best
scientific breakthroughs into clinical application for patients
across a wide range of cancers. By working collaboratively with
academic institutions, individual researchers, cooperative research
groups, governments and licensing partners, Pfizer Oncology strives
to cure or control cancer with its breakthrough medicines. Because
Pfizer Oncology knows that success in oncology is not measured
solely by the medicines you manufacture, but rather by the
meaningful partnerships you make to have a more positive impact on
people’s lives.
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 healthcare
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer healthcare
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, Pfizer has worked to make a difference for
all who rely on us. For more information, please visit us at
www.pfizer.com. In addition, to learn more, 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 February 21, 2017. 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
inotuzumab ozogamicin, an investigational oncology therapy,
including its potential benefits, that involves 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, 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 inotuzumab
ozogamicin may be filed in any other jurisdictions; whether and
when the BLA, MAA and any other such applications for inotuzumab
ozogamicin may be approved by the FDA, the EMA or other regulatory
authorities, respectively, 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;
decisions by regulatory authorities regarding labeling and other
matters that could affect the availability or commercial potential
of inotuzumab ozogamicin; 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, 2015 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 National Cancer Institute: Adult Acute Lymphoblastic Leukemia
Treatment (PDQ®) – General Information About Adult Acute
Lymphoblastic Leukemia (ALL). Available at:
http://www.cancer.gov/cancertopics/pdq/treatment/adultALL/HealthProfessional/page1.
Accessed March 21, 2016.2 American Cancer Society: Typical
treatment of acute lymphocytic leukemia. Available at:
http://www.cancer.org/cancer/leukemia-acutelymphocyticallinadults/detailedguide/leukemia-acute-lymphocytic-treating-typical-treatment.
Accessed March 21, 2016.3 American Cancer Society: What are the key
statistics about acute lymphocytic leukemia? Available
at:http://www.cancer.org/cancer/leukemia-acutelymphocyticallinadults/detailedguide/leukemia-acute-lymphocytic-key-statistics
. Accessed January 26, 2017.4 Manal Basyouni A. et al. Prognostic
significance of survivin and tumor necrosis factor-alpha in adult
acute lymphoblastic leukemia.
doi:10.1016/j.clinbiochem.2011.08.1147.5 Fielding A. et al. Outcome
of 609 adults after relapse of acute lymphoblastic leukemia (ALL);
an MRC UKALL12/ECOG 2993 study. Blood. 2006; 944-950.6 Leonard J et
al. Epratuzumab, a Humanized Anti-CD22 Antibody, in Aggressive
Non-Hodgkin’s Lymphoma: a Phase I/II Clinical Trial Results.
Clinical Cancer Research. 2004; 10: 5327-5334.7 DiJoseph JF.
Antitumor Efficacy of a Combination of CMC-544 (Inotuzumab
Ozogamicin), a CD22-Targeted Cytotoxic Immunoconjugate of
Calicheamicin, and Rituximab against Non-Hodgkin’s B-Cell Lymphoma.
Clin Cancer Res. 2006; 12: 242-250.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170221005530/en/
For Pfizer Inc.Media:Sally Beatty, 212-733-6566orInvestors:Ryan
Crowe, 212-733-8160
Pfizer (NYSE:PFE)
Historical Stock Chart
From Mar 2024 to Apr 2024
Pfizer (NYSE:PFE)
Historical Stock Chart
From Apr 2023 to Apr 2024