加拿大批准Onivyde安能得於胰腺癌使用 - 股票

1.原文連結：
https://goo.gl/JYKaRg

2.原文內容：
ONIVYDE, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), is the
first and only treatment shown to increase median overall survival by up to t
wo months for adult pancreatic cancer patients who have disease progression fo
llowing gemcitabine-based therapy.2

TORONTO, Aug. 11, 2017 /CNW/ - Shire Pharma Canada ULC (Shire Canada) today an
nounced that ONIVYDE (irinotecan liposome for injection) has been approved for
the treatment of metastatic adenocarcinoma of the pancreas, in combination wi
th 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have disea
se progression following gemcitabine-based therapy.3 ONIVYDE is the first and
only approved treatment option for this patient population who have no univers
ally accepted standard of treatment until now.4 Based on the NAPOLI-1 trial, O
NIVYDE has been shown to extend patients' overall survival by two additional m
onths.5

"At Shire, we have a clear goal to develop and deliver innovative therapies fo
r underserved cancer patients in need of breakthrough therapies," said Eric Ts
e, General Manager of Shire Canada. "We are proud to launch ONIVYDE in Canada
and continue our mission of making a real difference in the lives of people li
ving with cancer."

Pancreatic cancer is the fourth leading cause of cancer-related death in Canad
a. Yet little progress has been made in preventing, detecting and treating the
disease relative to other leading cancer killers.6 Survival rates for pancrea
tic cancer remain the lowest among other types of cancer. If recent trends con
tinue, the disease is expected to surpass breast cancer as the third leading c
ause of cancer deaths in the country.7

With the pancreas so deep in the abdomen, about 60 per cent of pancreatic canc
ers are detected at a late stage, which significantly contributes to its poor
prognosis.8 It is estimated that 5,500 Canadians will be diagnosed with pancre
atic cancer in 2017, but only 50 per cent of those are expected to survive bey
ond about four months after diagnosis.9 While first-line treatments are availa
ble to patients, disease progression after initial therapy is common, leaving
patients with no options for further treatment.10 About 4,800 Canadians are pr
edicted to succumb to pancreatic cancer this year.11

"There have been very few treatment advancements for metastatic pancreatic can
cer over the years. Until now, when patients failed on their first line drug,
they would be left without any good options," says Dr. Jeff Rothenstein, medi
cal oncologist at the R.S. McLaughlin Durham Regional Cancer Center in Oshawa.
"The approval of ONIVYDE means pancreatic cancer patients have another treatm
ent option that could help them continue their fight against the disease."

ONIVYDE was evaluated in NAPOLI-1, the first global, phase III trial to demons
trate a positive outcome in patients with disease progression following gemcit
abine-based therapy.12 Patients who received ONIVYDE in combination with 5-FU/
LV saw significant improvements in median overall survival (45 per cent increa
se), progression-free survival (100 per cent increase) and objective response
rate (16.2 per cent) relative to those who received 5-FU/LV alone (0.8 per cen
t).13

"Treating pancreatic cancer is challenging, especially given the disease's vag
ue symptoms which are often mistaken for benign conditions. This frequent misd
iagnosis means many patients are diagnosed with pancreatic cancer at a late st
age," says Stefanie Condon-Oldreive, Founder and Director of Craig's Cause Pan
creatic Cancer Society. "This new treatment is exciting news because it means
patients have a new option to turn to, one that could improve their quality of
life and provide them with meaningful time with those they love. For pancreat
ic cancer patients, that time is of the utmost importance."

"We lose thousands of Canadians to pancreatic cancer every year and yet we don
't see quite as much advancement in the treatment of this disease compared to
other types of cancer," says Michelle Capobianco, Executive Director of Pancre
atic Cancer Canada. "This new treatment option is a step in the right directio
n and is the kind of progress we want to see for years to come."

About ONIVYDE

ONIVYDE is indicated for the treatment of metastatic adenocarcinoma of the pan
creas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult
patients who have disease progression following gemcitabine-based therapy.14

ONIVYDE's active ingredient irinotecan is encapsulated in a long-circulating l
iposomal form.15 Through this unique delivery system, ONIVYDE prolongs drug ci
rculation and may lead to increased accumulation of the drug and its active me
tabolite (SN-38) in the tumor.16 Studies have suggested that encapsulation hel
ps to improve delivery of irinotecan to tumors, such as metastatic pancreatic
cancer.17

Do not substitute ONIVYDE for or with other drug products containing irinoteca
n. ONIVYDE is not indicated as a single agent for the treatment of patients wi
th metastatic adenocarcinoma of the pancreas and should only be administered u
nder the supervision of a physician who is experienced in the use of cancer ch
emotherapeutic agents.18

ONIVYDE should not be taken by patients who have experienced severe hypersensi
tivity reactions to ONIVYDE, other non-liposomal irinotecan or any other ingre
dient in the formulation or component of the container. It should also not be
taken while breastfeeding.19

Patients may experience diarrhea while on ONIVYDE and should be monitored clos
ely, and given fluids and electrolytes as needed. Early onset diarrhea can occ
ur with cholinergic symptoms, but happen infrequently and can be treated with
atropine. Late onset diarrhea can be life threatening and must be treated prom
ptly with loperamide or equivalent medications. Antibiotic therapy should be a
dministered if patients develop ileus (a lack of movement in the intestines),
fever or severe neutropenia (abnormally low levels of white blood cells that h
elps fight infection20).21

ONIVYDE is a registered trademark used under license from Ipsen Biopharm Ltd.

About NAPOLI-1

NAPOLI-1 is a randomized, open-label, multicentre, global, phase III trial in
417 patients with metastatic adenocarcinoma of the pancreas who had progressed
following gemcitabine-based therapy.22 Patients were enrolled in 76 sites in
14 across North America, South America, Europe, Asia and Australia.23

The study evaluated three regimens: 5-fluorouracil (5-FU) and leucovorin (LV),
ONIVYDE in combination with 5-FU/LV and ONIVYDE as a monotherapy.24 Patients
randomized to ONIVYDE+5-FU/LV arm received ONIVYDE 70 mg/m2 as an intravenous
infusion over 90 minutes, followed by LV 400 mg/m2 intravenously over 30 minut
es, followed by 5-FU 2400 mg/m2 intravenously over 46 hours, every 2 weeks. Th
e ONIVYDE dose of 70 mg/m2 is based on irinotecan anhydrous free base (equival
ent to 80 mg/m2 of irinotecan as the hydrochloride trihydrate).25

NAPOLI-1 demonstrated that ONIVYDE combined with 5-FU/LV improved overall surv
ival by 45 per cent and progression-free survival by 100 per cent as well as d
isplayed an objective response rate of 16.2 per cent compared to 0.8 per cent
with 5-FU/LV alone.26 ONIVYDE plus 5-FU/LV demonstrated a significant increase
in median overall survival versus 5-FU/LV alone: 6.1 months vs 4.2 months (ba
sed on a non-stratified hazard ratio [HR] of 0.67; 95% CI 0.49-0.92, p=0.012).
27

The following adverse events occurred at a higher incidence in the ONIVYDE+5-F
U/LV arm or ONIVYDE arm than in the 5-FU/LV arm (arm difference of 5%, Grade
1-4): diarrhea (59 per cent), vomiting (52 per cent), nausea (51 per cent), d
ecreased appetite (44 per cent), fatigue (40 per cent), neutropenia or a decre
ase in neutrophil white blood cells (39 per cent), anemia (38 per cent) and hy
pokalemia or decreased potassium level (12 per cent).28 Grade 3 or 4 adverse e
vents that occurred most frequently in patients assigned ONIVYDE plus 5-FU/LV
were neutropenia (27 per cent), diarrhea (13 per cent), vomiting (11 per cent)
, and fatigue (14 per cent).29

About Pancreatic Cancer

Most pancreatic cancers start in exocrine cells which produce enzymes that hel
p the body digest food and absorb nutrients.30 As the pancreas is located so d
eep in the abdomen, pancreatic cancer often develop for weeks or months withou
t presenting symptoms.31 As tumors grow, they begin to put pressure on nearby
organs causing pain, nausea, weight loss, jaundice and itching.32

Most cases of pancreatic cancer are discovered at a late stage when curative s
urgery is no longer an option. It is also relatively unresponsive to chemother
apy and radiation. As a result, prognosis for the disease is often poor.33

About Shire

Shire is the leading global biotechnology company focused on serving people wi
th rare diseases and other highly specialized conditions. We strive to develop
best-in-class products, many of which are available in more than 100 countrie
s, across core therapeutic areas including Hematology, Immunology, Neuroscienc
e, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal Medic
ine / Endocrine and Hereditary Angioedema; and a growing franchise in Oncology
.

Our employees come to work every day with a shared mission: to develop and del
iver breakthrough therapies for the hundreds of millions of people in the worl
d affected by rare diseases and other high-need conditions, and who lack effec
tive therapies to live their lives to the fullest.

About Shire Pharma Canada ULC

Shire Pharma Canada ULC is a subsidiary of Shire. Our Canadian office is locat
ed in Toronto, Ontario. For more information, please visit:

3.心得/評論：
所以這不算是智擎的利多嗎？怎都沒有新聞報導？還是這只是無關痛癢的消息？最近除了
這則報導之外，似乎沒看到其他特別的進展了。

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