Spectrum Pharmaceuticals Announces Submission to the U.S. Food & Drug Administration of Updated Biologics License Application...
October 24 2019 - 4:00PM
Business Wire
ROLONTIS BLA filing is based on two large pivotal randomized
controlled studies that met all primary and secondary
endpoints.
ROLONTIS is a novel, long-acting granulocyte colony-stimulating
factor (G-CSF) seeking an indication for the treatment of
neutropenia in patients receiving myelosuppressive anti-cancer
drugs.
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology
company with a primary focus in hematology and oncology, announced
today that the company submitted an updated Biologics License
Application (BLA) to the U.S. Food and Drug Administration (FDA)
for ROLONTIS (eflapegrastim).
The BLA for ROLONTIS is supported by data from two identically
designed Phase 3 clinical trials, ADVANCE and RECOVER, which
evaluated the safety and efficacy of ROLONTIS in 643 early-stage
breast cancer patients for the treatment of neutropenia due to
myelosuppressive chemotherapy. In both studies, ROLONTIS
demonstrated the pre-specified hypothesis of non-inferiority (NI)
in Duration of Severe Neutropenia (DSN) and a similar safety
profile to pegfilgrastim. ROLONTIS also demonstrated
non-inferiority to pegfilgrastim in the DSN across all 4 cycles
(all NI p<0.0001) in both studies.
“We have submitted a robust package to the FDA that incorporates
strong clinical data and addresses previously communicated FDA
requests relating to manufacturing processes,” said Joe Turgeon,
President and CEO of Spectrum. “ROLONTIS could be the first novel
G-CSF available to healthcare providers in over 15 years and, if
approved, we are looking forward to competing in this
multibillion-dollar market.”
In March 2019, Spectrum voluntarily withdrew the ROLONTIS BLA
that it filed with the FDA in 2018. The updated BLA filed today
includes additional information in the Chemistry, Manufacturing and
Controls (CMC) section.
About ADVANCE
The ADVANCE trial was a Phase 3, multicenter, randomized,
active-controlled, open label trial that enrolled 406 early-stage
breast cancer patients, who received docetaxel and cyclophosphamide
chemotherapy every 21 days for four cycles. Patients were
randomized in a 1:1 ratio to receive ROLONTIS or pegfilgrastim
(eflapegrastim n=196; pegfilgrastim n=210). The primary trial
endpoint was the DSN (absolute neutrophil counts [ANC]
<0.5×109/L) in Cycle 1, based on central laboratory assessment
of ANC over the 21-day cycle. Secondary endpoints included the DSN
in Cycles 2, 3, and 4, time to ANC recovery, depth of ANC nadir and
incidence of febrile neutropenia at Cycle 1. Patients with stage I
to stage IIIA breast cancer were treated with four cycles of
adjuvant/neo-adjuvant docetaxel and cyclophosphamide. On Day 2 of
each cycle, patients received a single dose of either eflapegrastim
13.2 mg/0.6 mL (3.6 mg G-CSF) or pegfilgrastim (6 mg)
subcutaneously. ADVANCE was conducted under a special protocol
assessment (SPA) with the FDA.
About RECOVER
The RECOVER trial was a Phase 3, multicenter, randomized,
active-controlled, open label trial that enrolled 237 breast cancer
patients who received docetaxel and cyclophosphamide chemotherapy
every 21 days. Patients were randomized in a 1:1 ratio to receive
ROLONTIS (n=118) or pegfilgrastim (n=119). The primary trial
endpoint was the DSN in Cycle 1 of chemotherapy (absolute
neutrophil count [ANC] <0.5×10^9/L), based on central laboratory
assessment of ANC over a 21-day cycle. Secondary endpoints included
the DSN in Cycles 2, 3, and 4, time to ANC recovery, depth of ANC
nadir and incidence of febrile neutropenia at Cycle 1. Patients
with stage I to stage IIIA breast cancer were treated on Day 1 of
each of the four cycles with adjuvant/neo-adjuvant docetaxel and
cyclophosphamide. On Day 2 of each cycle, patients received a
single dose of either eflapegrastim 13.2 mg/0.6 mL (3.6 mg G-CSF)
or pegfilgrastim (6 mg) subcutaneously.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biopharmaceutical company focused
on acquiring, developing, and commercializing novel and targeted
products, with a primary focus in hematology and oncology. 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. Spectrum has a late-stage
pipeline with novel assets that serve areas of unmet need. This
pipeline has the potential to transform the company in the near
future.
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 Spectrum’s 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, the timing and results of FDA decisions,
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 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 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.® and ROLONTIS® are registered
trademark of Spectrum Pharmaceuticals, Inc and its affiliate.
REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are
trademarks owned by Spectrum Pharmaceuticals, Inc. Any other
trademarks are the property of their respective owners.
© 2019 Spectrum Pharmaceuticals, Inc. All Rights Reserved
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COMPANY CONTACT Shiv Kapoor Vice President, Strategic Planning
& Investor Relations 702-835-6300
InvestorRelations@sppirx.com
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