1.原文連結(必須檢附)：http://goo.gl/LaEEvK
2.原文內容：
FDA Approves MM-398 Regimen for Metastatic Pancreatic Cancer
Silas Inman @silasinman
Published Online: Thursday, October 22, 2015
Dr. Richard Pazdur
Richard Pazdur, MD
The FDA has approved MM-398 (irinotecan liposome injection; Onivyde) in
combination with 5-fluorouracil (5-FU) and leucovorin as a treatment for
patients with metastatic pancreatic cancer following prior administration of
a gemcitabine-based regimen.
The approval was based on data from the phase III NAPOLI-1 trial, which
demonstrated a 1.9-month improvement in overall survival (OS) with the
addition of MM-398 to 5-FU and leucovorin. In the combination arm, the median
OS was 6.1 months compared with 4.2 months with 5-FU and leucovorin alone
(HR, 0.57; 95% CI, 0.41-0.80; P = .0009).
“Many FDA staff who review drug applications are clinicians as well, so it’
s especially rewarding when we are able to expedite access to new treatments
for patients with unmet needs,” Richard Pazdur, MD, director of the Office
of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation
and Research, said in a statement. “By using the Priority Review designation
for the application for Onivyde, patients will have earlier access to a drug
that helps extend survival.”
In the international trial, 417 patients with gemcitabine-refractory
metastatic pancreatic cancer were randomized to MM-398 monotherapy, 5-FU with
leucovorin (control), or MM-398 plus 5-FU and leucovorin. Per standard
irinotecan protocols, dexamethasone and a 5-HT3 antagonist could be
administered in the combination arms.
In the control, 5-FU was administered at 2000 mg/m2 with racemic leucovorin
at 200 mg/m2 weekly for 4 weeks followed by 2 weeks of rest (n = 149). In the
combination arm, intravenous MM-398 was administered at 80 mg/m2 prior to
5-FU at 2400 mg/m2 and racemic leucovorin at 400 mg/m2 every 2 weeks (n =
117). In the monotherapy group, MM-398 was administered at 120 mg/m2 every 3
weeks (n = 151).
Altogether, 61% of patients had cancer in the head of the pancreas and 68%
had liver metastases. A majority of the patients (83%) were enrolled outside
of the United States. In the combination arm, the median age of patients was
63 years, 64% were Caucasian, and 29% were Asian.
The median progression-free survival was 3.1 months for the combination
compared with 1.5 months with the control (HR, 0.56; 95% CI, 0.41-0.75; P =
.0001). At 12 weeks, 57% of patients treated with the combination were alive
and progression-free compared with 26% with 5-FU and leucovorin alone.
The objective response rate by RECIST v1.1 criteria was 16% versus 1%, for
the combination and control, respectively (P <.001). For those with baseline
CA19-9 levels of >30 U/ml at baseline (84% in the combination arm), there was
a duction inC
3.心得/評論(必需填寫)：
http://finance.yahoo.com/q?s=mack
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警語來應景一下：
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