|[August 08, 2014]
FDA Approves VELCADE® (bortezomib) Retreatment in Patients with Multiple Myeloma
CAMBRIDGE, Mass. --(Business Wire)--
Millennium: The Takeda Oncology Company with its parent company, Takeda
Pharmaceutical Company Limited (TSE:4502), today announced that the U.S.
Food and Drug Administration (FDA) has approved VELCADE® (bortezomib)
for the retreatment of adult patients with multiple myeloma (MM) who had
previously responded to VELCADE therapy and relapsed at least six months
following completion of prior VELCADE treatment. The labeling update
includes dosing guidelines as well as safety and efficacy findings for
the use of VELCADE as a single agent or VELCADE in combination with
dexamethasone in patients previously treated with VELCADE. VELCADE
retreatment may be started at the last tolerated dose.
The approved retreatment sNDA consisted of a Phase 2 study and other
supportive data. The Phase 2 international RETRIEVE trial showed a 38.5
percent overall response rate (ORR) in multiple myeloma patients who had
been previously treated with a VELCADE-based regimen (median of two
prior lines of therapy) and had previously achieved a partial response
or better. The safety profile seen with VELCADE retreatment was
consistent with the known safety profile of intravenous VELCADE in
relapsed multiple myeloma; no cumulative toxicities were observed upon
retreatment. The most common adverse drug reaction was thrombocytopenia,
which occurred in 52 percent of the patients.
"For the past 11 years, VELCADE has played an important role as the only
therapy proven to extend overall survival for patients with newly
diagnosed and relapsed multiple myeloma," said Michael Vasconcelles, MD,
Global Head, Oncology Therapeutic Area Unit, Takeda. "With these newly
approved dosing guidelines, physicians will be able to provide their
patients, who have previously received VELCADE, with an effective
treatment extending VELCADE use across the continuum of care of multiple
RETRIEVE was a single arm, open-label trial. The study enrolled 130
patients ages 18 years and older who had previously responded to
VELCADE-based therapy and relapsed at least six months after prior
treatment with VELCADE. The study met its primary endpoint of best
confirmed response to retreatment as assessed by European Group for
Blood and Marrow Transplantation (EBMT) criteria.
Patients had received a median of two prior therapies (range of 1-7).
Dexamethasone was administered in combination with VELCADE in 94
Of the 130 patients, one patient achieved complete response and 49
achieved partial response (50/130; ORR 38.5 percent).
In the 50 responding patients, the median duration of response was 6.5
months (range of 0.6 to 19.3 months).
The incidence ofgrade =3 thrombocytopenia was 24 percent. Peripheral
neuropathy occurred in 28 percent of patients, with the incidence of
grade =3 peripheral neuropathy reported at 6 percent. The incidence of
serious adverse reactions was 12.3 percent; the most commonly reported
serious adverse reactions were thrombocytopenia (3.8 percent),
diarrhea (2.3 percent), herpes zoster and pneumonia (1.5 percent
each). Adverse reactions leading to discontinuation occurred in 13
percent of patients.
VELCADE: Important Safety Information
VELCADE® (bortezomib) is approved for the treatment of patients with
multiple myeloma. VELCADE is also approved for the treatment of patients
with mantle cell lymphoma who have already received at least one prior
Patients should not receive VELCADE if they are allergic to bortezomib,
boron or mannitol. VELCADE should not be administered intrathecally.
Women should avoid becoming pregnant or breastfeeding while taking
VELCADE. Patients with diabetes may require close monitoring and
adjustment of their medication. VELCADE can cause serious side effects,
Peripheral neuropathy. Nerve problems, which can
be severe including muscle weakness, tingling, burning, pain, or loss
of feeling in the hands and feet.
Low blood pressure. A drop in blood pressure
resulting in dizziness, light headedness or fainting.
Heart problems. Heart rhythm problems and heart
failure including worsening of existing conditions. Symptoms may
include chest pressure or pain, palpitations, swelling of the ankles
or feet, or shortness of breath.
Lung problems, some of which have been fatal. Symptoms
include cough, shortness of breath, wheezing or difficulty breathing.
Liver problems. Liver failure including a yellow
discoloration of the eyes and skin.
Posterior reversible encephalopathy syndrome (PRES). A
rare, reversible condition involving the brain. Symptoms may include
seizures, high blood pressure, headaches, tiredness, confusion,
blindness, or other vision problems
Gastrointestinal problems. Nausea, vomiting, diarrhea
Thrombocytopenia and neutropenia. Lowering
the levels of blood cells, which could result in a higher risk for
infections or bleeding.
Tumor lysis syndrome (TLS). TLS is a
syndrome that causes a chemical imbalance in the blood that could lead
to heart and/or kidney problems.
Common side effects seen in patients receiving VELCADE include: fever,
decreased appetite, fatigue, rash.
These are not all of the possible side effects with VELCADE. Please see
the full Prescribing Information for VELCADE for a complete list
available at VELCADE.com.
VELCADE® (bortezomib) is co-developed by Millennium/Takeda and Janssen
Pharmaceutical Companies. Millennium is responsible for
commercialization of VELCADE in the U.S.; Janssen Pharmaceutical
Companies are responsible for commercialization in Europe and the rest
of the world. Takeda Pharmaceutical Company Limited and Janssen
Pharmaceutical K.K. co-promote VELCADE in Japan. VELCADE is approved in
more than 90 countries and has been used to treat more than 550,000
About Millennium: The Takeda Oncology Company
Millennium: The Takeda Oncology Company, a leading biopharmaceutical
company based in Cambridge, Mass., markets a first-in-class proteasome
inhibitor and has a robust pipeline of oncology product candidates.
Additional information about Millennium is available through its
Located in Osaka, Japan, Takeda is a research-based global company with
its main focus on pharmaceuticals. As the largest pharmaceutical company
in Japan and one of the global leaders of the industry, Takeda is
committed to strive towards better health for patients worldwide through
leading innovation in medicine. Additional information about Takeda is
available through its corporate website, www.takeda.com.
Editors' Note: This press release is also available under the Media
section of the Company's website at: www.millennium.com/InTheNews.aspx.
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