The Cancer Letter

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

Drugs & Targets

Pfizer gets Complete Response Letter for trastuzumab biosimilar

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

Pfizer Inc. announced it has received a Complete Response Letter from FDA in response to the Biologics License Application for the company’s proposed trastuzumab biosimilar. In the CRL, FDA highlighted the need for additional technical information.

The additional requested information does not relate to safety or clinical data submitted in the application, the company said. Pfizer said it’s working closely with FDA to address the contents of the letter.

Table of Contents

YOU MAY BE INTERESTED IN

Podcast

What happened at FDA? Replimune approval raises questions

Last week, FDA granted accelerated approval to Replimune Group Inc. for it’s biologic, RP1 (vusolimogene oderparepvec), following the FDA Cellular, Tissue, and Gene Therapies Advisory Committee’s 10:3 vote in support of the biologic in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.
Regulatory News

FDA grants Replimune’s RP1 an accelerated approval on third submission after 10:3 vote from advisory committee
Amid political outcry, advisors accept weak data and give sponsor a chance to complete phase III trial

FDA has granted an accelerated approval to RP1 (vusolimogene oderparepvec) following the agency’s Cellular, Tissue, and Gene Therapies Advisory Committee’s 10:3 vote in support of the biologic in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.
By Jacquelyn Cobb and Paul Goldberg
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