The Multiple Myeloma Research Foundation (MMRF) today announced that its
partner, Onyx Pharmaceuticals, Inc., received U.S. Food and Drug
Administration (FDA) approval for Kyprolis™ (carfilzomib) for the
treatment of patients with multiple myeloma who have received at least
two prior therapies, including Velcade (bortezomib) for Injection and an
immunomodulatory agent, such as Thalomid (thalidomide) or Revlimid
(lenalidomide), and have demonstrated disease progression on or within
60 days of completion of the last therapy. The approval of Kyprolis is
based on response rate.
The MMRF's affiliate organization, the Multiple Myeloma Research
Consortium (MMRC), a clinical trials network of 16 leading multiple
myeloma centers in North America, has bolstered the clinical development
of Kyprolis for the past six years, providing clinical trial support and
resources, including driving accrual to the pivotal Phase IIb trial
(003-A1) that supported the accelerated approval of the treatment.
"The approval of Kyprolis is an immensely important milestone for the
multiple myeloma patient community, which continues to face significant
unmet need in terms of safe and effective treatments for advanced
disease. While we have seen tremendous progress in the past decade,
multiple myeloma remains incurable," stated Kathy Giusti, Founder and
CEO of the MMRF and MMRC and a multiple myeloma patient. "We commend the
FDA and Onyx for their dedication to enabling patient access to
Kyprolis, and are proud of our long-term and continued partnership with
Onyx throughout the development of this critical new treatment."
In 2006, the MMRF identified Kyprolis as a promising new treatment for
advanced multiple myeloma during its development by Proteolix, Inc.
(acquired by Onyx in 2009), and entered into a collaboration to support
the therapy's development. Since that time, the MMRF has provided
integral support to advance its clinical development, including:
Facilitating early Phase I clinical trials and three Phase II trials
with Kyprolis within the MMRC network, including: the pivotal Phase
IIb trial (003-A1) that supported its approval by the FDA, the
original Phase II trial (003), and the Phase II trial (004) in
patients who had relapsed after one to three prior therapies. Today,
three combination trials involving Kyprolis are ongoing within the
MMRC, including a Phase II trial for newly diagnosed patients and two
Phase I trials evaluating the drug in combination with other
Providing Onyx access to the MMRC network of clinical experts,
securing trial investigators, supplying centralized contracts,
providing guidance on site selection and protocol design, and accruing
patients to ensure that clinical work was done in the most
high-quality and efficient way possible to benefit patients.
Raising awareness and driving enrollment to ASPIRE, Onyx's pivotal
Phase III clinical trial with Kyprolis, which is now fully enrolled,
and informing the entire multiple myeloma community on emerging data
from clinical trials, involving Kyprolis.
Partnering with Onyx on the Carfilzomib Myeloma Access Program
(C-MAP), an Expanded Access program that made carfilzomib available to
hundreds of eligible patients in the U.S. before FDA approval.
"Over the past five years, through C-MAP and trials facilitated by the
MMRC, in partnership with Proteolix and Onyx, the MMRF facilitated
access to Kyprolis to more than 500 patients, many of whom had exhausted
all available treatment options," stated Walter M. Capone, Chief
Operating Officer of the MMRF and MMRC. "Beyond these studies and
programs, Onyx has shown a deep commitment to the multiple myeloma
community through its extensive clinical development program. We are
very much looking forward to the opportunity for a much broader group of
patients, particularly those with the greatest unmet need, to access
this breakthrough therapy."
Source: Multiple Myeloma Research Foundation (MMRF)