Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a
biopharmaceutical company focused on novel and targeted oncology
announced today that a permanent J-code, J1449, has been issued for
ROLVEDON (eflapegrastim-xnst) Injection by the U.S. Centers for
Medicare & Medicaid Services (CMS) effective as of April 1,
2023.
“This is an important milestone in the ROLVEDON launch. A
permanent J-code will enable a more efficient and predictable
reimbursement in the outpatient setting. The combination of a
permanent J-code on April 1, 2023 and ROLVEDON’S inclusion in the
National Comprehensive Cancer Network® Supportive Care Guidelines
(NCCN Guidelines) announced on December 6, 2022 are key elements in
establishing brand awareness and building customer confidence in
our novel product,” said Tom Riga, President and Chief Executive
Officer of Spectrum Pharmaceuticals.
J-codes are permanent reimbursement codes used by commercial
insurance plans, Medicare, Medicare Advantage, and other government
payers for Medicare Part B drugs like ROLVEDON that are
administered by a physician. Claims submission and documentation
are simplified with a permanent J-code, facilitating and
streamlining the billing and reimbursement process.
The permanent J-code for ROLVEDON, J1449 (Injection,
eflapegrastim-xnst, 0.1 mg), will take effect April 1, 2023. The
permanent J-code is published online on the CMS website here.
About ROLVEDON™
ROLVEDON™ (eflapegrastim-xnst) injection is a long-acting
granulocyte colony-stimulating factor (G-CSF) with a novel
formulation. Spectrum has received an indication to decrease the
incidence of infection, as manifested by febrile neutropenia, in
adult patients with non-myeloid malignancies receiving
myelosuppressive anti-cancer drugs associated with clinically
significant incidence of febrile neutropenia. ROLVEDON is not
indicated for the mobilization of peripheral blood progenitor cells
for hematopoietic stem cell transplantation. The BLA for ROLVEDON
was supported by data from two identically designed Phase 3,
randomized, open-label, noninferiority clinical trials, ADVANCE and
RECOVER, which evaluated the safety and efficacy of ROLVEDON in 643
early-stage breast cancer patients for the management of
neutropenia due to myelosuppressive chemotherapy. In both studies,
ROLVEDON demonstrated the pre-specified hypothesis of
non-inferiority (NI) in mean duration of severe neutropenia (DSN)
and a similar safety profile to pegfilgrastim. ROLVEDON also
demonstrated non-inferiority to pegfilgrastim in the mean DSN
across all four cycles (all NI p<0.0001) in both trials.
Please see the Important Safety Information below and the full
prescribing information for ROLVEDON at www.rolvedon.com.
Indications and Usage
ROLVEDON is indicated to decrease the incidence of infection, as
manifested by febrile neutropenia, in adult patients with
non-myeloid malignancies receiving myelosuppressive anti-cancer
drugs associated with clinically significant incidence of febrile
neutropenia.
Limitations of Use
ROLVEDON is not indicated for the mobilization of peripheral
blood progenitor cells for hematopoietic stem cell
transplantation.
Important Safety Information
Contraindications
- ROLVEDON is contraindicated in patients with a history of
serious allergic reactions to eflapegrastim, pegfilgrastim or
filgrastim products. Reactions may include anaphylaxis.
Warnings and Precautions
Splenic Rupture
- Splenic rupture, including fatal cases, can occur following the
administration of recombinant human granulocyte colony-stimulating
factor (rhG-CSF) products. Evaluate patients who report left upper
abdominal or shoulder pain for an enlarged spleen or splenic
rupture.
Acute Respiratory Distress Syndrome (ARDS)
- ARDS can occur in patients receiving rhG-CSF products. Evaluate
patients who develop fever, lung infiltrates, or respiratory
distress. Discontinue ROLVEDON in patients with ARDS.
Serious Allergic Reactions
- Serious allergic reactions, including anaphylaxis, can occur in
patients receiving rhG-CSF products. Permanently discontinue
ROLVEDON in patients who experience serious allergic
reactions.
Sickle Cell Crisis in Patients with Sickle Cell
Disorders
- Severe and sometimes fatal sickle cell crises can occur in
patients with sickle cell disorders receiving rhG-CSF products.
Discontinue ROLVEDON if sickle cell crisis occurs.
Glomerulonephritis
- Glomerulonephritis has occurred in patients receiving rhG-CSF
products. The diagnoses were based upon azotemia, hematuria
(microscopic and macroscopic), proteinuria, and renal biopsy.
Generally, events of glomerulonephritis resolved after
dose-reduction or discontinuation. Evaluate and consider dose
reduction or interruption of ROLVEDON if causality is likely.
Leukocytosis
- White blood cell (WBC) counts of 100 x 109/L or greater have
been observed in patients receiving rhG-CSF products. Monitor
complete blood count (CBC) during ROLVEDON therapy. Discontinue
ROLVEDON treatment if WBC count of 100 x 109/L or greater
occurs.
Thrombocytopenia
- Thrombocytopenia has been reported in patients receiving
rhG-CSF products. Monitor platelet counts.
Capillary Leak Syndrome
- Capillary leak syndrome has been reported after administration
of rhG-CSF products and is characterized by hypotension,
hypoalbuminemia, edema and hemoconcentration. Episodes vary in
frequency and severity and may be life-threatening if treatment is
delayed. If symptoms develop, closely monitor and give standard
symptomatic treatment, which may include a need for intensive
care.
Potential for Tumor Growth Stimulatory Effects on Malignant
Cells
- The granulocyte colony-stimulating factor (G-CSF) receptor
through which ROLVEDON acts has been found on tumor cell lines. The
possibility that ROLVEDON acts as a growth factor for any tumor
type, including myeloid malignancies and myelodysplasia, diseases
for which ROLVEDON is not approved, cannot be excluded.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia
(AML) in Patients with Breast and Lung Cancer
- MDS and AML have been associated with the use of rhG-CSF
products in conjunction with chemotherapy and/or radiotherapy in
patients with breast and lung cancer. Monitor patients for signs
and symptoms of MDS/AML in these settings.
Aortitis
- Aortitis has been reported in patients receiving rhG-CSF
products. It may occur as early as the first week after start of
therapy. Consider aortitis in patients who develop generalized
signs and symptoms such as fever, abdominal pain, malaise, back
pain, and increased inflammatory markers (e.g., c-reactive protein
and white blood cell count) without known etiology. Discontinue
ROLVEDON if aortitis is suspected.
Nuclear Imaging
- Increased hematopoietic activity of the bone marrow in response
to growth factor therapy has been associated with transient
positive bone imaging changes. This should be considered when
interpreting bone imaging results.
Adverse Reactions
- The most common adverse reactions (≥20%) were fatigue, nausea,
diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia,
arthralgia, and back pain.
- Permanent discontinuation due to an adverse reaction occurred
in 4% of patients who received ROLVEDON. The adverse reaction
requiring permanent discontinuation in 3 patients who received
ROLVEDON was rash.
To report SUSPECTED ADVERSE REACTIONS, contact Spectrum
Pharmaceuticals, Inc. at 1-888-713-0688 or FDA at 1800FDA1088
or www.fda.gov/medwatch
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, Inc. is a biopharmaceutical company
focused on acquiring, developing, and commercializing novel and
targeted oncology therapies. Spectrum has a strong track record of
successfully executing across the biopharmaceutical business model,
from in-licensing and acquiring differentiated drugs, clinically
developing novel assets, successfully gaining regulatory approvals
and commercializing in a competitive healthcare marketplace. For
additional information on Spectrum please visit www.sppirx.com.
Notice Regarding Forward-looking Statements
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 the future success of Spectrum’s commercial launch of ROLVEDON,
including the aggregate size of the LA-GCSF market and Spectrum’s
ability to generate future sales into the community oncology clinic
segment, 340B and non-340B hospitals and other systems within the
market, the ability of Spectrum’s pricing strategy to deliver near-
and long-term value to clinics it serves, Spectrum's ability to
identify, acquire, develop and commercialize a broad and diverse
pipeline of late-stage clinical and commercial products, and any
other 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 Spectrum’s 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 dependence on third parties for clinical trials,
manufacturing, distribution and quality control; the impact of the
COVID-19 pandemic, geopolitical issues and inflation on our
business and operations, supply chain and labor force and other
risks that are described in further detail in the Company's reports
filed with the Securities and Exchange Commission. The Company does
not plan to update any such forward-looking statements and
expressly disclaims 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™ and ROLVEDON™ are the Spectrum Pharmaceuticals’ logos
and trademarks owned by Spectrum Pharmaceuticals, Inc. Any other
trademarks are the property of their respective owners.
© 2023 Spectrum Pharmaceuticals, Inc. All Rights Reserved
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Tom Riga Chief Executive Officer 949.788.6700
InvestorRelations@sppirx.com
Lisa Wilson In-Site Communications, Inc. 212.452.2793
lwilson@insitecony.com
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