FDA Grants Spectrum Pharmaceuticals Approval of EVOMELA™ (melphalan) for Injection
EVOMELA Received FDA Approval for Two Indications:
High-Dose Conditioning Treatment for Multiple Myeloma (MM)
Patients Undergoing Autologous Stem Cell Transplantation (ASCT)
Palliative Treatment of Patients with MM Who Cannot Take Oral
EVOMELA Admixture Solution is Stable for 4 Hours at Room
Temperature in Addition to the 1 Hour Following Reconstitution
EVOMELA Does Not Contain Propylene Glycol
Company Plans to Launch EVOMELA with Existing Sales Force in a
Market Estimated at Approximately $100 Million
HENDERSON, Nev.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with
fully integrated commercial and drug development operations with a
primary focus in Hematology and Oncology, announced today that the U.S.
Food and Drug Administration (FDA) has granted approval of EVOMELA for
use in two indications: 1) use as a high-dose conditioning treatment
prior to hematopoietic progenitor (stem) cell transplantation (ASCT) in
patients with multiple myeloma (MM), and 2) for the palliative treatment
of patients with MM for whom oral therapy is not appropriate. This is
the first product to be FDA-approved for the high-dose conditioning
indication in MM.
"I am very proud to announce that Spectrum has been able to bring
another new cancer drug to the market," said Rajesh C. Shrotriya, MD,
Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "This
represents the commercialization of our sixth Hematology/Oncology
product in the U.S. Our EVOMELA formulation does not contain propylene
glycol and is reconstituted and admixed with normal saline. This new
formulation also uses Captisol technology, which allows the admixture
solution to be stable for 4 hours at room temperature in addition to the
1 hour following reconstitution and has been used in several other
FDA-approved products. We are very excited about the approval of EVOMELA
as this fits seamlessly into our existing commercial infrastructure. In
addition to our five other currently marketed products, we believe
revenues from EVOMELA will help us expeditiously develop the potential
blockbusters that we have in our late-stage pipeline."
"The approval of EVOMELA marks the first new formulation of melphalan
approved by the FDA, since its initial approval in 1964," said Dr.
Parameswaran Hari, Armand J. Quick/William F. Stapp Professor of
Hematology at the Medical College of Wisconsin, Director of the Adult
Blood and Marrow Transplant Program at Froedtert Hospital and the
Section Head of Hematologic Malignancies and Transplantation, in the
Division of Hematology and Oncology in the Department of Medicine.
"Melphalan is extensively used in the treatment of multiple myeloma and
is the main drug in conditioning therapy pre-transplant. EVOMELA's new
formulation does not contain propylene glycol and is stable for 4 hours
at room temperature in addition to the 1 hour following reconstitution."
Spectrum Pharmaceuticals gained global development and commercialization
rights to EVOMELA from Ligand Pharmaceuticals Incorporated (NASDAQ:
LGND) in March 2013. Spectrum assumed responsibility for completing the
pivotal Phase 2 clinical trial, and was responsible for filing the NDA.
Under the license agreement, Ligand received a license fee and is
eligible to receive milestone payments, as well as royalties following
About Multiple Myeloma
Multiple Myeloma is a systemic malignancy of plasma cells that
accumulate in the bone marrow, usually associated with monoclonal
antibody secretion, and results in bone marrow failure and bone
destruction. It is the second most common hematologic disease with
nearly 30,000 new cases projected in the US in 2016 and over 11,000
deaths annually (American Cancer Society Stats, 2016). The rate of ASCT
for patients with MM is growing by approximately 3.3% annually.
Melphalan is the most commonly used IV agent for high-dose conditioning
for patients undergoing ASCT for MM. The current IV melphalan market is
approximately $100 million annually, with predominant use in ASCT;
EVOMELA is the only intravenous melphalan product that is approved for
use in the high-dose conditioning indication.
EVOMELA was approved by FDA based on its bioequivalence to the standard
melphalan formulation (Alkeran) in a Phase 2 clinical study (Aljitawi et
al, Bone Marrow Transplant, 2014) via the 505(b)(2) regulatory pathway.
EVOMELA has been granted Orphan Drug Designation by the FDA for its use
as a high-dose conditioning regimen for patients with MM undergoing ASCT.
EVOMELA's new melphalan formulation does not contain propylene glycol.
The use of the Captisol® technology to reformulate also
contributes to the 4-hour admixture stability of EVOMELA at room
temperature. This is in addition to the 1 hour stability of
reconstituted EVOMELA drug product at room temperature and 24 hour
stability at refrigerated temperature (5°C).
Please see the Important Safety Information below and the full
prescribing information, including BOXED WARNINGS, for EVOMELA at www.evomela.com.
Important Safety Information
WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY, and
Severe bone marrow suppression with resulting infection or
bleeding may occur. Controlled trials comparing intravenous (IV)
melphalan to oral melphalan have shown more myelosuppression
with the IV formulation. Monitor hematologic laboratory
Hypersensitivity reactions, including anaphylaxis, have
occurred in approximately 2% of patients who received the IV
formulation of melphalan. Discontinue treatment with EVOMELA for
serious hypersensitivity reactions.
Melphalan produces chromosomal aberrations in vitro
and in vivo. EVOMELA should be considered potentially
leukemogenic in humans.
History of serious allergic reaction to melphalan.
Warnings and Precautions
Nausea, vomiting, diarrhea or oral mucositis may occur. Provide
supportive care using antiemetic and antidiarrheal medications as
Hepatic disorders ranging from abnormal liver function tests to
clinical manifestations such as hepatitis and jaundice have been
reported after treatment with melphalan. Hepatic veno-occlusive
disease has also been reported. Monitor liver chemistries.
EVOMELA can cause fetal harm when administered to a pregnant woman.
Advise females of reproductive potential to avoid pregnancy during and
after treatment with EVOMELA. If this drug is used during pregnancy or
if the patient becomes pregnant while taking this drug, advise the
patient of potential risk to the fetus.
Melphalan-based chemotherapy regimens have been reported to cause
suppression of ovarian function in premenopausal women, resulting in
persistent amenorrhea in approximately 9% of patients. Reversible or
irreversible testicular suppression has also been reported.
The most common adverse reactions observed in at least 50% of patients
with multiple myeloma treated with EVOMELA were neutrophil count
decreased (100%), white blood cell count decreased (100%), lymphocyte
count decreased (98%), platelet count decreased (98%), diarrhea (93%),
nausea (90%), fatigue (77%), hypokalemia (74%), anemia (66%), and
In a single-arm clinical study, twelve (20%) patients with multiple
myeloma who received EVOMELA conditioning for ASCT experienced a
treatment emergent serious adverse reaction. The most common serious
adverse reactions ( > 1 patient, 1.6%) were pyrexia, hematochezia,
febrile neutropenia, and renal failure.
In a randomized clinical trial studying the palliative treatment of
patients with multiple myeloma, severe myelotoxicity (WBC ≤1,000
and/or platelets ≤25,000) was more common in the IV melphalan arm
(28%) than in the oral melphalan arm (11%).
No formal drug interaction studies have been conducted. When nalidixic
acid and IV melphalan are given simultaneously, the incidence of
severe hemorrhagic necrotic enterocolitis has been reported to
increase in pediatric patients.
Use in Specific Populations
It is not known whether melphalan is present in human milk. Because
many drugs are excreted in human milk and because of the potential for
serious adverse reactions in nursing infants from melphalan, breastfeeding
is not recommended during treatment with EVOMELA.
Advise females of reproductive potential to avoid pregnancy, which may
include the use of effective contraception methods, during and after
treatment with EVOMELA.
For Palliative Treatment, consider dose reduction for patients with
renal impairment receiving EVOMELA.
Captisol is a patent-protected, chemically modified cyclodextrin with a
structure designed to optimize the solubility and stability of drugs.
Captisol was invented and initially developed by scientists in the
laboratories of Dr. Valentino Stella at the University of Kansas'
Higuchi Biosciences Center for specific use in drug development and
formulation. This unique technology has enabled six FDA-approved
products, including Onyx Pharmaceuticals' Kyprolis®, Baxter
International's Nexterone® and Merck's NOXAFIL IV. There are
also more than 30 Captisol-enabled products currently in clinical
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company focused on
acquiring, developing, and commercializing drug products, with a primary
focus in Hematology and Oncology. Spectrum currently markets six
hematology/oncology drugs, and expects an FDA decision on another drug
in the second half of 2016. Additionally, Spectrum's pipeline includes
two drugs targeting blockbuster markets in advanced stages of clinical
development. Spectrum's strong track record for in-licensing and
acquiring differentiated drugs, and expertise in clinical development
have generated a robust, diversified, and growing pipeline of product
candidates in advanced-stage Phase 2 and Phase 3 studies. More
information on Spectrum is available at www.sppirx.com.
Forward-looking statement — This press release may contain
forward-looking statements regarding future events and the future
performance of Spectrum Pharmaceuticals that involve risks and
uncertainties that could cause actual results to differ materially. These
statements are based on management's current beliefs and expectations.
These statements include, but are not limited to, statements that
relate to our business and its future, including certain company
milestones, Spectrum's ability to identify, acquire, develop and
commercialize a broad and diverse pipeline of late-stage clinical and
commercial products, leveraging the expertise of partners and employees
around the world to assist us in the execution of our strategy, and any
statements that relate to the intent, belief, plans or expectations of
Spectrum or its management, or that are not a statement of historical
fact. Risks that could cause actual results to differ include the
possibility that our existing and new drug candidates may not prove safe
or effective, the possibility that our existing and new applications to
the FDA and other regulatory agencies may not receive approval in a
timely manner or at all, the possibility that our existing and new drug
candidates, if approved, may not be more effective, safer or more cost
efficient than competing drugs, the possibility that our efforts to
acquire or in-license and develop additional drug candidates may fail,
our lack of sustained revenue history, our limited marketing experience,
our dependence on third parties for clinical trials, manufacturing,
distribution and quality control and other risks that are described in
further detail in the Company's reports filed with the Securities and
Exchange Commission. We do not plan to update any such
forward-looking statements and expressly disclaim any duty to update the
information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC.® is a registered
trademark of Spectrum Pharmaceuticals, Inc and its affiliates. REDEFINING
CANCER CARE™, EVOMELA™ and the Spectrum Pharmaceuticals logos are
trademarks owned by Spectrum Pharmaceuticals, Inc. Any other
trademarks are the property of their respective owners.
© 2016 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160315005663/en/
Spectrum Pharmaceuticals, Inc.
Shiv Kapoor, 702-835-6300
President, Strategic Planning & Investor Relations
Source: Spectrum Pharmaceuticals, Inc.
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