Janssen-Cilag, announced the European Commission's favorable reception of VELCADE
in compounding with melphalan and liquid Pred for the treatment of patients
with previously untreated multiple myeloma (MM) world Health Organization are not eligible for
high-dose chemotherapy with ivory marrow transplant.
In more than than 87 countries world-wide, VELCADE monotherapy had already been
approved for the treatment of relapsed and / or refractory MM in patients who
make received at least one prior therapy.
"VELCADE has already made an authoritative contribution for patients with
multiple myeloma at first relapse," said Professor Jesus San Miguel, M.D.,
University of Salamanca in Spain, the corpus investigator for the VISTA
trial. "The marketing mandate from the EMEA is encouraging as it
suggests that more patients may benefit from earlier handling."
The frontline approval is based on phase III results from the VISTA
trial, latterly published in the New England Journal of Medicine, which
demonstrated statistically higher-ranking results across all efficaciousness endpoints
compared to melphalan and meticorten. In special, complete response (CR)
rates were like to those that experience been achieved in the transplant
setting.
Notes
- Multiple myeloma (MM) is the second most common blood cancer,
representing approximately one percent of all cancers and 2 percent
of all cancer deaths(i).
- In 2002, there were approximately 85,700 cases of MM world-wide(ii).
- Only 30 percent of MM patients survive yearner than five years(tercet),
with more than 18,000 people in the European Union dying each year
from the disease(iv).
About the VISTA study
VISTA stands for: VELCADE as Initial Standard Therapy in Multiple
Myeloma: Assessment with melphalan and prednisone (VISTA) results. More
information is available upon request.
About VELCADE(R)
VELCADE is the showtime proteasome inhibitor to receive worldwide regulatory
approval for the treatment of multiple myeloma (MM). In 2005, VELCADE was
approved in the European Union for MM after first fall back and has now
received approval from the European Commission in combination with melphalan
and prednisone for the treatment of patients with antecedently untreated MM who
ar not eligible for high-dose chemotherapy with bone sum transplant.
Clinical trials ar underway to investigate the potential of VELCADE in
additional settings and in combination with other antineoplastic drugs to
enhance discourse effects or reverse resistance(v).
VELCADE has a well-defined safety profile and a favorable benefit-risk
proportion. The most common side effects reported with VELCADE include tiredness,
gastrointestinal adverse events, transient thrombocytopenia and neuropathy,
which is reversible in the majority of patients.
VELCADE is a market leader in treating relapsed multiple myeloma with
over C,000 patients treated planetary. VELCADE is being co-developed by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) and
Millennium: The Takeda Oncology Company. Millennium is responsible for
commercialisation of VELCADE in the U.S. Janssen-Cilag companies are
responsible for commercialization in Europe and the rest of the world.
Janssen Pharmaceutical K.K. is responsible for commercialisation in Japan.
About Janssen-Cilag
The Janssen-Cilag companies have a long racecourse record in developing and
marketing treatments for central nervous system disorders, pain management,
oncology, infectious diseases, reproductive health and gastrointestinal
disorders.
Janssen-Cilag
View drug information on Velcade.
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