Item 7.01 Regulation FD Disclosure.
On July 3, 2014, Spectrum Pharmaceuticals, Inc. (the "Company") received
notification from the U.S. Food and Drug Administration ("FDA") of their early
action granting accelerated approval of the Company's New Drug Application
("NDA") for Beleodaq™ (belinostat) for Injection for the treatment of patients
with relapsed or refractory peripheral T-cell lymphoma ("PTCL"). This indication
was approved by FDA under accelerated approval based on tumor response rate and
duration of response. An improvement in survival or disease-related symptoms has
not been established. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in the confirmatory trial.
Important Beleodaq safety information is included in the attachment hereto as
Exhibit 99.1 and is incorporated herein by reference.
Item 2.04. Triggering Events That Accelerate or Increase a Direct Financial
Obligation or an Obligation under an Off-Balance Sheet Arrangement.
As previously announced, in 2010 the Company licensed the oncology drug asset
Beleodaq (belinostat) for Injection from TopoTarget A/S ("TopoTarget") through a
License and Collaboration Agreement (the "Agreement") for all uses in North
, with an option for China
(as is defined in the Agreement). In
connection with the transaction, TopoTarget remained eligible to receive
contingent consideration upon the achievement of certain regulatory and sales
milestones. As a result of the satisfaction of a NDA approval milestone,
described above, pursuant to the Agreement, the Company becomes obligated to pay
TopoTarget $25 million
Item 8.01 Other Events.
On July 3, 2014
, the Company received further notifications from the FDA
regarding the post marketing requirements ("PMRs") for each of Beleodaq and
Folotyn®. With respect to Folotyn, the two previous Folotyn PMRs for the Phase 3
PTCL trial and the Phase 3 cutaneous T-cell lymphoma ("CTCL") trial have been
released by FDA
. The new PMRs for Beleodaq and Folotyn include a main study that
evaluates the comparative efficacy and safety of Folotyn when used in
combination with the treatment regimen cyclophosphamide/
vincristine/doxorubicin/prednisone ("CHOP") or the combination of Beleodaq plus
CHOP, versus CHOP alone for the initial therapy of patients with PTCL. Important
safety information for Beleodaq and Folotyn is included in the attachment hereto
as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
Exhibit No. Description
99.1 Important Safety Information for BELEODAQ (belinostat) for
Injection and FOLOTYN (pralatrexate injection)