Melanoma one of fastest growing cancers in Canada
MONTREAL, Feb. 7, 2012 /CNW/ - The approval by Health Canada of YERVOYTM (ipilimumab) is welcome news for Canadians with the deadliest form of
skin cancer, metastatic melanoma, who are fighting to live longer.
Yervoy, a cancer immunotherapy, is the first and only treatment
approved for advanced melanoma in Canada that has been proven to extend
survival in a phase three trial. Yervoy (3 mg/kg) is indicated for the
treatment of unresectable or metastatic melanoma in patients who have
failed or do not tolerate other systemic therapy for advanced disease.
Melanoma is one of the fastest growing cancers in Canada and the second
most common cancer in young adults aged 15 to 34. The incidence has
more than tripled over the last 30 years and continues to increase. An
estimated 5,500 Canadians will be diagnosed with melanoma this year and
950 will die from it. Advanced melanoma cases represent 15 per cent of
new melanoma patients in Canada. It is estimated that 1,200 Canadians
are living with unresectable melanoma. Melanoma is responsible for 75
per cent of the deaths associated with skin cancer.
Demonstrated longer survival with Yervoy
In a pivotal randomized phase three clinical study, the median overall
survival was 10 months for Yervoy and six months for the comparator
treatment, a peptide vaccine (gp100).
Furthermore, the Kaplan-Meier estimated survival rate with Yervoy at
both one and two years was almost doubled when measured against
patients treated with gp100, 46 per cent versus 25 per cent at one year
and 24 per cent versus 14 per cent at two years. Yervoy also showed
long-term survival with some patients alive at three and four years.
The types of adverse events (AEs) attributed to Yervoy are generally
related to its mechanism of action, i.e., immune-based.
Immune-mediated adverse reactions, sometimes fatal, include
enterocolitis, intestinal perforation, hepatitis, dermatitis,
neuropathy, endocrinopathy as well as toxicity in other organ systems.
Adverse events associated with Yervoy are managed by the administration
of systemic corticosteroids, dose discontinuation and/or the use of
"Once diagnosed with metastatic melanoma, a patient's average life
expectancy is about three to 18 months, depending upon the extent and
location of disease. This dismal prognosis has not changed in over 40
years. With approval of Yervoy we now have the chance to offer some
patients with advanced melanoma real hope for long-term survival," said
Dr. David Hogg, a medical oncologist with a large melanoma practice in
Toronto. "With its unique mode of action, it is also an important step
forward in the use of immunotherapy to treat cancer. It activates a
patient's own immune system to better identify and kill the melanoma
Mode of action
Unlike traditional chemotherapy, Yervoy indirectly targets the tumour by
stimulating the patient's immune system to recognize and destroy
melanoma cells. Yervoy specifically blocks cytotoxic T
lymphocyte-associated antigen-4 (CTLA-4), which plays a role in
suppressing the normal immune response. Yervoy blocks that suppression
to allow the immune system to respond to melanoma cancer cells.
Also unlike most other medicines for advanced cancer, which are commonly
given until the disease progresses, a complete course of treatment with
Yervoy includes four infusions over a three-month period. Patients
receive Yervoy every three weeks for four doses.
Last year, Derek Mason of Belleville, Ontario, was considered to be in
the final stages of melanoma when his doctor was able to enroll him in
a clinical trial with Yervoy. "Last year during my battle with melanoma
I wasn't expecting to reach my 40th birthday or celebrate Christmas, but I did," Mason said. "Thanks to
Yervoy, I am seeing progress and the melanoma, which had spread to many
parts of my body, is regressing. I'm so thankful for my much improved
condition. I'm living each day to the fullest, enjoying time with my
wife and three young daughters."
Kathy Barnard, founder of Save Your Skin Foundation, a group dedicated
to raising awareness about skin cancer, providing information about
treatment options and funding research, said, "It's heartbreaking to
see so many Canadians losing their battle with melanoma and, given that
most patients with advanced melanoma survive less than a year, time is
critical. My wish is for all Canadians who need it to have access to
Yervoy as soon as possible to give them a chance to survive this
Bristol-Myers Squibb Canada (BMS Canada) is working with federal,
provincial and territorial authorities to ensure patients in Canada
will have access to Yervoy through provincial and private drug plans as
quickly as possible.
BMS Canada is committed to making Yervoy available to previously treated
patients who meet specific eligibility requirements through the BMS
Canada Access to Hope patient assistance program.
"Melanoma is growing fastest in young adults and prevention is vital
because 90 per cent of melanomas are caused by exposure to UV light and
sunlight, including tanning beds," said Annette Cyr, Chair of the
Melanoma Network of Canada. "We are so pleased that the approval of
Yervoy in Canada will provide a treatment option that can potentially
extend survival of people who receive this terrible diagnosis. We also
hope that this will encourage governments to make melanoma a priority."
"The Canadian Dermatology Association is committed to raising awareness
of melanoma, and we encourage Canadians to take steps to protect their
skin from this serious disease," said Dr. Denise Wexler, President of
the Canadian Dermatology Association. "Today's approval is great news
for patients with advanced melanoma and we welcome this new treatment
Yervoy is the first compound from Bristol-Myers Squibb's robust
immuno-oncology pipeline, which includes a variety of other compounds
with the potential to harness the patient's immune system to fight
cancer. The company is an important player in the fight against cancer.
It provided its first anti-cancer medication to Canadians more than
four decades ago and continues to invest in research and development to
respond to critical needs.
Melanoma is a rare but deadly form of skin cancer. It is characterized
by the uncontrolled growth of pigment-producing cells (melanocytes)
located in the skin. Unlike many cancers, melanoma is clearly visible
on the skin. Ninety per cent of melanomas are caused by exposure to UV
light, including tanning beds.
Metastatic melanoma occurs when cancer spreads beyond the surface of the
skin to other organs, such as the lymph nodes, lungs, brain or other
areas of the body. Unresectable melanoma is a melanoma that cannot be
removed or resected by surgery. The survival rate for melanoma is high
if it is detected early but the advanced form, metastatic melanoma, is
an aggressive disease which, until now, was characterized by high
The total direct and indirect cost of skin cancer in Canada in 2004 was
estimated at $531.75 million, of which more than 80 per cent ($443.48
million) was from malignant melanoma.
Yervoy is a recombinant, human monoclonal antibody and the first
approved cancer immunotherapy for melanoma to target the CTLA-4
(cytotoxic T lymphocyte-associated antigen-4), which plays a role in
suppressing normal immune function.
Yervoy was approved by the United States Food and Drug Administration on
March 25, 2011, and by the drug regulatory bodies of the European Union
and Australia in July 2011.
In a pivotal randomized phase three clinical study, published in The New
England Journal of Medicine, 676 patients in the study had all
undergone previous treatment. The median overall survival was 10 months
(95 per cent CI: 8.0-13.8) for Yervoy, six months (95 per cent CI:
5.5-8.7) for the comparator treatment (gp100) and 10 months (95 per
cent CI: 8.5-11.5) for Yervoy + gp100, with p-values of 0.0026 (not
adjusted for multiple comparisons) for Yervoy and 0.0004 for Yervoy +
gp100 vs. gp100, respectively. The Kaplan-Meier estimated survival rate
at one year was 46 per cent (95 per cent CI: 37.0, 54.1) in the Yervoy
arm vs. 25 per cent (95 per cent CI: 18.1, 32.9) in the gp100 arm. The
estimated survival rate at two years was 24 per cent (95 per cent CI:
16.0, 31.5) in the Yervoy arm vs. 14 per cent (95 per cent CI: 8.0,
20.0) in the gp100 arm. In the study, Yervoy showed long-term survival
with some patients alive at three and four years.
Early diagnosis and appropriate management are essential to minimize
life-threatening complications. Signs and symptoms suggestive of
immune-mediated adverse reactions may be non-specific and should be
considered Yervoy-related, unless an alternate etiology is identified.
Most immune-mediated adverse reactions occurred during the treatment
period; however, onset months after the last dose of Yervoy has also
In the phase three study, the most common adverse reactions were
diarrhea (27 per cent), rash (26 per cent), pruritus (26 per cent),
fatigue (24 per cent), nausea (23 per cent), vomiting (12 per cent),
decreased appetite (11 per cent), and abdominal pain (11 per cent) for
the Yervoy alone arm; diarrhea (29 per cent), rash (20 per cent),
pruritus (18 per cent), fatigue (23 per cent), nausea (19 per cent),
vomiting (9 per cent), decreased appetite (10 per cent), and abdominal
pain (10 per cent) for gp100 arm. Ten per cent of patients treated with
Yervoy and four per cent of patients treated with gp100 had to
discontinue their therapy because of adverse reactions.
About Bristol-Myers Squibb Canada
Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of
Bristol-Myers Squibb Company, a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines that
help patients prevail over serious diseases. Bristol-Myers Squibb
Canada is a leading provider of medicines to fight cancer,
cardiovascular and metabolic disorders, infectious diseases (including
HIV/AIDS), nervous system diseases and serious mental illness.
Bristol-Myers Squibb Canada's operations are headquartered in Montreal,
For medical information about Yervoy, please contact BMS Canada medical information line at: 1-866-463-6267
For information about the BMS Canada Access to Hope Patient Assistance Program, please contact 1-877-967-6626
YervoyTM is a trademark of Bristol-Myers Squibb Company.
Video with caption: "Video: Health Canada approves Yervoy". Video available at: http://stream1.newswire.ca/cgi-bin/playback.cgi?file=20120207_C9949_VIDEO_EN_9722.mp4&posterurl=http://photos.newswire.ca/images/20120207_C9949_PHOTO_EN_9722.jpg&clientName=BRISTOL%2DMYERS%20SQUIBB%20CANADA&caption=Video%3A%20Health%20Canada%20approves%20Yervoy&title=BRISTOL%2DMYERS%20SQUIBB%20CANADA%20%2D%20Health%20Canada%20approves%20Yervoy&headline=First%20and%20only%20treatment%20to%20extend%20survival%20for%20people%20with%20metastatic%20melanoma%2C%20the%20most%20deadly%20form%20of%20skin%20cancer%2C%20approved%20in%20Canada
Image with caption: "Yervoy Product Shot. (CNW Group/BRISTOL-MYERS SQUIBB CANADA)". Image available at: http://photos.newswire.ca/images/download/20120207_C9949_PHOTO_EN_9726.jpg
Image with caption: "Examination of moles. (CNW Group/BRISTOL-MYERS SQUIBB CANADA)". Image available at: http://photos.newswire.ca/images/download/20120207_C9949_PHOTO_EN_9728.jpg
Audio with caption: "Audio: Yervoy approved in Canada". Audio available at: http://stream1.newswire.ca/media/2012/02/07/20120207_C9949_AUDIO_EN_9730.mp3
Audio with caption: "Audio:Yervoy patient story ". Audio available at: http://stream1.newswire.ca/media/2012/02/07/20120207_C9949_AUDIO_EN_9731.mp3
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