The U.S. Food and Drug Administration today approved Onivyde
(irinotecan liposome injection), in combination with fluorouracil and
leucovorin, to treat patients with advanced (metastatic) pancreatic
cancer who have been previously treated with gemcitabine-based
chemotherapy.
The FDA granted Priority Review and orphan drug designations for Onivyde. Priority Review
status is granted to applications for drugs that, if approved, would be
a significant improvement in safety or effectiveness in the treatment
of a serious condition. Orphan drug designation
provides incentives such as tax credits, user fee waivers, and
eligibility for orphan drug exclusivity to assist and encourage the
development of drugs for rare diseases.
The effectiveness of
Onivyde was demonstrated in a three-arm, randomized, open label study of
417 patients with metastatic pancreatic adenocarcinoma whose cancer had
grown after receiving the chemotherapeutic drug gemcitabine or a
gemcitabine-based therapy. The study was designed to determine whether
patients receiving Onivyde plus fluorouracil/leucovorin or Onivyde alone
lived longer than those receiving fluorouracil/leucovorin. Patients
treated with Onivyde plus fluorouracil/leucovorin lived an average of
6.1 months, compared to 4.2 months for those treated with only
fluorouracil/leucovorin. There was no survival improvement for those who
received only Onivyde compared to those who received
fluorouracil/leucovorin.
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