Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.)
Food and Drug Administration (FDA) has approved TRAZIMERA™
(trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab),1 for
the treatment of human epidermal growth factor receptor-2 (HER2)
overexpressing breast cancer and HER2 overexpressing metastatic
gastric or gastroesophageal junction adenocarcinoma.2
“This is an important milestone in the U.S. which both adds to
our growing portfolio of oncology treatments and has the potential
to improve access to cancer care,” said Andy Schmeltz, Global
President, Pfizer Oncology. “We are proud to be able to offer
treatment options that can help address the diverse needs of
patients.”
The FDA approval was based on review of a comprehensive data
package, which demonstrated a high degree of similarity between
TRAZIMERA and the originator product. This includes results from
the REFLECTIONS B327-02 clinical comparative study that was
recently published in the British Journal of Cancer, which showed
clinical equivalence, finding a high degree of similarity and no
clinically meaningful differences between TRAZIMERA and the
originator product in patients with first line HER2 overexpressing
metastatic breast cancer.3
“Approximately 15-30% of breast cancers and 10-30% of gastric
cancers are HER2-positive, which is associated with aggressive
disease and poor prognoses for patients,” said Dr. Mark Pegram,
associate director for clinical research at the Stanford
Comprehensive Cancer Institute, and director of the Breast Oncology
Program at the Stanford Women’s Cancer Center.4 “With the
availability of biosimilars like TRAZIMERA in the U.S., oncologists
will have additional treatment options to choose from, which may
help provide patients with greater access to the medicines they
need.”
Pfizer has a robust portfolio of potential biosimilar candidates
in mid- to late-stage development.5 TRAZIMERA is Pfizer’s first
oncology monoclonal antibody (mAb) biosimilar and Pfizer’s fifth
biosimilar to be approved by the FDA.2,6,7,8,9 TRAZIMERA was also
approved for use in the EU in July 2018 for the treatment of HER2
overexpressing breast cancer and HER2 overexpressing metastatic
gastric or gastroesophageal junction adenocarcinoma.10
About TRAZIMERA (trastuzumab-qyyp)
TRAZIMERA is a monoclonal antibody (mAb) biosimilar of the
originator biologic medicine, Herceptin, which targets HER2, a
protein found on the surface of some cancer cells which can
stimulate the cells to divide and grow.11 TRAZIMERA locks on to the
HER2 protein and blocks the receptors, stopping cell division and
growth.10
As part of the REFLECTIONS clinical trial program, TRAZIMERA has
been studied in nearly 500 patients and across more than 20
countries to date.12,13,14,15,16
TRAZIMERA IMPORTANT SAFETY INFORMATION
Possible Serious Side Effects With TRAZIMERA
(trastuzumab–qyyp)
Not all people have serious side effects, but side effects with
TRAZIMERA therapy are common.
Although some people may have a life-threatening side effect,
most do not.
Your doctor will stop treatment if any serious side effects
occur.
TRAZIMERA is not for everyone. Be sure to contact your doctor
if you are experiencing any of the following:
HEART PROBLEMS
These include heart problems—such as congestive heart failure or
reduced heart function—with or without symptoms. The risk for and
seriousness of these heart problems were highest in people who
received both trastuzumab and a certain type of chemotherapy
(anthracycline). In a study of adjuvant (early) breast cancer, one
patient died of significantly weakened heart muscle. Your doctor
will check for signs of heart problems before, during, and after
treatment with TRAZIMERA.
INFUSION REACTIONS, including:
- Fever and chills
- Feeling sick to your stomach
(nausea)
- Throwing up (vomiting)
- Pain (in some cases at tumor
sites)
- Headache
- Dizziness
- Shortness of breath
These signs usually happen within 24 hours after receiving
TRAZIMERA.
Be sure to contact your doctor if you:
Are a woman who could become pregnant, or may be
pregnant
TRAZIMERA may result in the death of an unborn baby or birth
defects. Contraception should be used while receiving TRAZIMERA and
after your last dose of TRAZIMERA. If you are exposed to TRAZIMERA
during pregnancy or within 7 months of becoming pregnant, you are
encouraged to report TRAZIMERA exposure to Pfizer at
1-800-438-1985.
Have any signs of SEVERE LUNG PROBLEMS, including:
- Severe shortness of breath
- Fluid in or around the lungs
- Weakening of the valve between the
heart and the lungs
- Not enough oxygen in the body
- Swelling of the lungs
- Scarring of the lungs
Your doctor may check for signs of severe lung problems when he
or she examines you.
Have LOW WHITE BLOOD CELL COUNTS
Low white blood cell counts can be life threatening. Low white
blood cell counts were seen more often in patients receiving
trastuzumab plus chemotherapy than in patients receiving
chemotherapy alone.
Your doctor may check for signs of low white blood cell counts
when he or she examines you.
Side Effects Seen Most Often With trastuzumab
Some patients receiving trastuzumab for breast cancer had the
following side effects:
- Fever
- Feeling sick to your stomach
(nausea)
- Throwing up (vomiting)
- Infusion reactions
- Diarrhea
- Infections
- Increased cough
- Headache
- Feeling tired
- Shortness of breath
- Rash
- Low white and red blood cell
counts
- Muscle pain
Some patients receiving trastuzumab for metastatic stomach
cancer had the following side effects:
- Low white blood cell counts
- Diarrhea
- Feeling tired
- Low red blood cell counts
- Swelling of the mouth lining
- Weight loss
- Upper respiratory tract infections
- Fever
- Low platelet counts
- Swelling of the mucous membranes
- Swelling of the nose and throat
- Change in taste
You should contact your doctor immediately if you have any of
the side effects listed above.
Please see full Prescribing Information for TRAZIMERA
(trastuzumab-qyyp), including BOXED WARNING.
About Pfizer Oncology
At Pfizer Oncology, we are committed to advancing medicines
wherever we believe we can make a meaningful difference in the
lives of patients. Today, Pfizer Oncology has an industry-leading
portfolio of 18 approved innovative cancer medicines and
biosimilars across more than 20 indications, including breast,
prostate, kidney, lung and hematology. Pfizer Oncology is striving
to change the trajectory of cancer.
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
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like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is
as of March 11, 2019. 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
TRAZIMERA (trastuzumab-qyyp), 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, uncertainties regarding the launch timing and commercial
success of TRAZIMERA in the United States; the uncertainties
inherent in research and development, including the ability to meet
anticipated clinical endpoints, commencement and/or completion
dates for our clinical trials, regulatory submission dates,
regulatory approval dates and/or launch dates, as well as the
possibility of unfavourable new clinical data and further analyses
of existing clinical data; the risk that clinical trial data are
subject to differing interpretations and assessments by regulatory
authorities; whether regulatory authorities will be satisfied with
the design of and results from our clinical studies; whether and
when applications for TRAZIMERA may be filed in any other
jurisdictions; whether and when any such other applications for
TRAZIMERA that may be pending or filed may be approved by
regulatory authorities, which will depend on myriad factors,
including making a determination as to whether the product’s
benefits outweigh its known risks and determination of the
product’s efficacy and, if approved, whether TRAZIMERA will be
commercially successful; intellectual property and/or litigation
implications; decisions by regulatory authorities impacting
labeling, manufacturing processes, safety and/or other matters that
could affect the availability or commercial potential of TRAZIMERA;
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, 2018 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 Herceptin® is a registered trademark of Genentech Inc.2
TRAZIMERA™ (trastuzumab-qyyp) Prescribing Information. New York.
NY: Pfizer Inc: 2019. Available at
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761081s000lbl.pdf.3
Pegram M, Bondarenko I, Zorzetto MMC, et al. PF-05280014 (a
trastuzumab biosimilar) plus paclitaxel compared with reference
trastuzumab plus paclitaxel for HER2-positive metastatic breast
cancer: a randomised, double-blind study. Br J Cancer. 2019
Jan;120(2):172-182. doi: 10.1038/s41416-018-0340-2. Epub 2018 Dec
20.4 Iqbal N, Iqbal N. Human Epidermal Growth Factor Receptor 2
(HER2) in Cancers: Overexpression and Therapeutic Implications. Mol
Biol Int. 2014. 10.1155/2014/852748.5 Pfizer Pipeline (as of
January 29, 2019). Available at
https://www.pfizer.com/sites/default/files/product-pipeline/Pipeline_Update_29JAN2019.pdf.
Accessed March 2019.6 INFLECTRA® (infliximab-dyyb) Prescribing
Information. New York. NY: Pfizer Inc: 2016. Available at
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125544s000lbl.pdf7
IXIFI™ (infliximab-qbtx) Prescribing Information. New York. NY:
Pfizer Inc: 2017. Available at
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761072s000lbl.pdf8
RETACRIT™ (epoetin alfa-epbx) Prescribing Information. New York.
NY: Pfizer Inc: 2018. Available at
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125545s003lbl.pdf9
NIVESTYM™ (filgrastim-aafi) Prescribing Information. New York. NY:
Pfizer Inc: 2018. Available at
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761080s000lbl.pdf10
European Medicines Agency. Herceptin Summary of Product
Characteristics. Available at
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000278/WC500074922.pdf.
Accessed March 2019.11 Macmillan Cancer Support. Trastuzumab.
Available at
https://www.macmillan.org.uk/cancerinformation/cancertreatment/treatmenttypes/biologicaltherapies/monoclonalantibodies/trastuzumab.aspx.
Accessed March 2019.12 Pegram M, Tan-Chiu E, Freyman A, et al.
Abstract 238PD. A randomized, double-blind study of PF-05280014 (a
potential trastuzumab biosimilar) vs trastuzumab, both in
combination with paclitaxel, as first-line treatment for
HER2-positive metastatic breast cancer. Presented at ESMO 2017.13
Lammers PE, Dank M, Masetti R, et al. A randomized, double-blind
study of PF-05280014 (a potential biosimilar) vs trastuzumab, both
given with docetaxel (D) and carboplatin (C), as neoadjuvant
treatment for operable human epidermal growth factor receptor
2-positive (HER2+) breast cancer. Abstract 154PD. Presented at ESMO
2017.14 Yin D, Barker K B, Li R, et al. A randomized phase 1
pharmacokinetic trial comparing the potential biosimilar
PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS
B327-01). BR J Clin Pharmacol. 2014. 78(6): 1281-90.15
Clinicaltrials.gov. NCT01989676. A study of PF-05280014
[trastuzumab-Pfizer] or Herceptin (trastuzumab) plus paclitaxel in
HER2 positive first line metastatic breast cancer treatment
(REFLECTIONS B327-02). Available at
https://clinicaltrials.gov/ct2/show/NCT01989676?term=NCT01989676&rank=1.
Accessed March 2019.16 Clinicaltrials.gov. NCT02187744. A study of
PF-05280014 or trastuzumab plus taxotere and carboplatin in HER2
positive breast cancer in the neoadjuvant setting (REFLECTIONS
B327-04). Available at
https://clinicaltrials.gov/ct2/show/NCT02187744?term=NCT02187744&rank=1.
Accessed March 2019.
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version on businesswire.com: https://www.businesswire.com/news/home/20190311005932/en/
Pfizer Inc.Media:Jessica Smith, +1 (212)
733-6213Jessica.M.Smith@pfizer.com
Investor:Ryan Crowe, +1 (212) 733-8160Ryan.Crowe@pfizer.com
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