The Cancer Letter

The leading source for information on the issues that shape oncology since 1973

Drugs & Targets

Supportive care biosimilar Nyvepria approved by FDA

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print
BYLINE
IN THIS ISSUE
DOWNLOAD PDFTABLE OF CONTENTS

Nyvepria (pegfilgrastim-apgf), a biosimilar to Neulasta (pegfilgrastim), received FDA approval.

Nyvepria is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Nyvepria is sponsored by Pfizer.

The FDA approval was based on the review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of NYVEPRIA to its reference product.

Table of Contents

YOU MAY BE INTERESTED IN

News Analysis

GRAIL presses on with Galleri test despite missed primary endpoint in pivotal study
Where GRAIL sees signals of benefit in the subgroups, screening experts see signs of overdiagnosis

If you listen to GRAIL executives discuss the results of the long-awaited trial of the company’s multicancer detection test, you might be led to conclude that the company’s pivotal NHS-Galleri study had an overwhelmingly positive result.
By Jacquelyn Cobb and Sara Willa Ernst
Conversation with The Cancer Letter

GRAIL’s Megan Hall: “I think we can be confident that there is clinical benefit to implementing this technology. And I think that’s really hard to argue with.”
Mainstream epidemiologists beg to differ

Undeterred by the negative topline result of its pivotal trial of Galleri, a multicancer detection test, the test’s sponsor, GRAIL, said it’s forging ahead with its plan to get FDA approval and reimbursement from CMS and private insurers.
By Jacquelyn Cobb and Sara Willa Ernst
Conversation with The Cancer Letter

NCI’s Philip Castle on NHS-Galleri results: “I’m sorry that it didn’t work, but it keeps the national conversation going.”
Castle is “disappointed” by Galleri results but not discouraged by implications for MCDs

Philip E. Castle, director of the NCI Division of Cancer Prevention, said he was disappointed to hear that GRAIL’s NHS-Galleri trial did not meet its primary endpoint of reduction in late-stage cancers.
By Jacquelyn Cobb and Sara Willa Ernst
Table of Contents

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login

Site license subscribers:
Log in with your IP | Register a sponsored account