d.d. 21 januari 2004:
Bron: persbericht van Scheering

Zevalin een immunologisch middel te gebruiken naast bestralingen van non-Hodgkin heeft van de Europese commissie toestemming gekregen als officieel geregistreerd medicijn te mogen worden gebruikt. De resultaten uit o.a. een gerandomiseerde fase III studie waren: 143 patiënten met een herhaald recidief van non-Hodgkin werden verdeeld over twee groepen. Bij de groep patiënten die Zevalin kregen reageerde 80% op dit medicijn tegenover 56 procent bij de groep die alleen Rituxan kreeg toegediend. 30% van de Zevalin groep kreeg een complete remissie en 4 procent een onbevestigde complete remissie tegenover respectievelijk 16% en 4% in de andere groep. Deze resultaten worden aangemerkt als significant. De remissie bij de patiënten duurde over vier trials gezien bijna twee jaar met een aantal patiënten die tot 6,5 jaar geen recidief vertoonden. Dit lijkt erg goed nieuws, aan de andere kant zit hier ook het addertje onder het gras namelijk met Zevalin wordt wel een remissie bereikt maar vaak geen definitieve genezing. Maar goed dit is o.i. weer een stap voorwaarts. Lees overigens ook eens het verhaal van mw. Bruins die met alleen dieet en suppletie nu al jaren geen recidief heeft van non-Hodgkin. Voor OPS-leden hebben we adresgegevens van contactpersonen bij Schering en Biogen voor u beschikbaar. 


CAMBRIDGE, Mass. and SAN DIEGO, Calif., Jan. 22 /PRNewswire-FirstCall/--
Biogen Idec (Nasdaq: BIIB) today announced that the European Commission has
granted marketing approval for ZEVALIN(R) (Ibritumomab tiuxetan)
radioimmunotherapy. ZEVALIN is approved in Europe for the treatment of adult
patients with CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL) who are
refractory to or have relapsed following RITUXAN(R) (rituximab) therapy. ZEVALIN
was approved in February 2002 by the U.S. Food and Drug Administration (FDA). It
is marketed and distributed by Biogen Idec in the U.S. Schering AG, Biogen
Idec's corporate partner, holds marketing and distribution rights for ZEVALIN
outside the U.S. and expects to launch the product in Europe within the next few
months.

"ZEVALIN radioimmunotherapy represents a major advancement in the treatment
of certain non-Hodgkin's lymphomas," said Burt Adelman, Executive Vice
President, Development for Biogen Idec. "We are pleased that through this
partnership with Schering AG, patients in Europe will soon have access to this
innovative therapy."
Radioimmunotherapy is a new area of cancer treatment that combines the
targeting power of monoclonal antibodies with the cell-damaging ability of
localized radiation. ZEVALIN is made by linking monoclonal antibodies to
radioactive isotopes. When infused into a patient, these radiation-carrying
antibodies circulate in the body until they locate and bind to the surface of
specific cells, and then deliver their cytotoxic radiation directly to malignant
cells. ZEVALIN binds to malignant and normal B-cells. Normal B-cells generally
are replenished by CD20-negative progenitor cells within six-to-nine months
following therapy.

About Clinical Studies
Extensive clinical studies of ZEVALIN have confirmed high response rates and
durable responses in patients with relapsed, refractory follicular or
transformed B-cell NHL:

-- In a Phase 2 study evaluating patients with follicular NHL who did not
respond to or responded inadequately to RITUXAN, ZEVALIN produced an
overall response rate of 74 percent, with 15 percent of patients
achieving a complete remission (disappearance of all evidence of
disease), according to International Workshop Response Criteria (IWRC).
-- A pivotal Phase 3 randomized, controlled trial was conducted in 143
patients with relapsed or refractory, low-grade or follicular NHL or
transformed B-cell NHL. The 73 patients who received the ZEVALIN
regimen showed an overall response rate of 80 percent, compared to 56
percent in the 70 patients who received RITUXAN alone. Thirty percent
of ZEVALIN patients achieved a complete remission and 4 percent
achieved an unconfirmed complete remission to therapy, compared to 16
percent of RITUXAN patients who achieved a complete remission and 4
percent who achieved an unconfirmed complete remission. The improvement
in ORR and CR were statistically significant.
-- ZEVALIN has been shown to induce durable remissions in many patients
with relapsed or refractory B-cell NHL, as evidenced by long-term
follow-up of complete responders from four registrational clinical
trials. The median duration of remission for these patients approached
two years, with some responses still ongoing at 75 months (6.25 years).
-- Thirty-seven percent of the responding patients treated in the
registrational trials achieved long-term responses, defined as time to
progression of longer than 12 months. Among these long-term responders,
the median duration of response was 28.1 months.
-- The registrational trials of ZEVALIN involved more than 30 academic and
community cancer centers in the U.S. and included the only randomized
clinical trial to date comparing radioimmunotherapy to another standard
therapy. A high proportion of the patients in the trials were greater
than 60 years old and had received three or more prior therapies.

Schering AG, Germany is currently investigating the use of ZEVALIN in the
treatment of aggressive NHL (i.e., diffuse large B-cell lymphoma) and as
consolidation therapy for follicular NHL in earlier disease stages.

About ZEVALIN
On February 19, 2002, the FDA approved ZEVALIN, a new type of targeted cancer
therapy called radioimmunotherapy, making it the first commercially available
radioimmunotherapy for the treatment of B-cell non-Hodgkin's lymphoma (NHL). A
unique treatment regimen for patients with certain types of B-cell NHL, the
ZEVALIN therapeutic regimen combines a monoclonal antibody with a radioisotope.
The monoclonal antibody in ZEVALIN recognizes and attaches to a particular
cell-surface part of a B-cell called the CD20 antigen. This allows ZEVALIN to
specifically target B-cells, destroying the malignant NHL B-cells and also
normal B-cells. ZEVALIN, as part of the ZEVALIN therapeutic regimen, is
indicated in the U.S. for the treatment of relapsed, or refractory low-grade,
follicular or transformed B-cell NHL, including patients with RITUXAN refractory
follicular NHL.
Today, ZEVALIN is being investigated in multiple clinical trials at major
medical centers in the U.S. and in a variety of treatment strategies, including
combinations with front-line and salvage chemotherapy regimens and as part of
autologous and allogeneic stem cell transplantation.

ZEVALIN Safety Profile
In safety data based upon 349 patients, the most serious adverse reactions of
the ZEVALIN therapeutic regimen were primarily hematologic, with grade 4
neutropenia, thrombocytopenia, and anemia occurring in 30 percent, 10 percent
and 3 percent of patients treated at the 0.4 mCi/kg dose, respectively.
Infusion-related toxicities were typically grade 1 or 2 and were associated with
pre-administration of Rituximab (RITUXAN). The risk of hematologic toxicity
correlated with the degree of bone marrow involvement prior to ZEVALIN therapy.
Seven percent of patients were hospitalized with infection or febrile neutropena
(3 percent) and fatal cerebral hemorrhage (less than 1 percent) has occurred in
a minority of patients in clinical studies. The annualized rate for the
development of treatment-related myelodysplasia or acute myelogenous leukemia is
less than 1 percent of patients and can occur at 8 to 34 months after treatment.
ZEVALIN should only be used by health care professionals qualified by
training and experience in the safe use of radionuclides. Fatal Infusion
Reactions: Rare deaths have occurred within 24 hours of Rituximab infusions.
These fatalities were associated with an infusion reaction symptom complex that
included hypoxia, pulmonary infiltrates, acute respiratory distress syndrome,
myocardial infarction, ventricular fibrillation, or cardiogenic shock. Prolonged
and Severe Cytopenias: Yttrium-90 Zevalin administration results in severe and
prolonged cytopenias in most patients.