Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Roche's T-DM1 Early Filing Strategy Backfires As FDA Refuses To File BLA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA issued a refusal to file letter for Roche's BLA for trastuzumab-DM1 (T-DM1) for accelerated approval because all the available treatment choices approved for metastatic breast cancer had not been exhausted in the study population, Roche said Aug. 27

You may also be interested in...

Review Challenge: Deduce Efficacy From One Subset Of One Single-Arm Trial

Genmab and GlaxoSmithKline provided FDA with data from two trials to support the efficacy of Arzerra in refractory chronic lymphocytic leukemia, but the agency only considered a subset of one of the studies to count for proof of efficacy

Avastin Breast Cancer Approval Debate Pits Clinical Benefit Versus Statistics

The Oncology Drugs Advisory Committee's vote against full approval of Roche's Avastin (bevacizumab) for first-line treatment of metastatic breast cancer hinged to a large degree on its feeling that the drug did not delay disease progression long enough to be clinically meaningful

Pfizer Pulls Mylotarg For Safety 10 Years After Accelerated Approval

Although Pfizer's voluntary withdrawal of its acute myeloid leukemia therapy Mylotarg is the first complete withdrawal of an accelerated approval NDA, but as in other cases where the confirmatory trial fails to substantiate the initial signs of efficacy that supported the accelerated approval, FDA is not completely closing the door on access to the drug


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts