BLA for Proposed Trastuzumab Biosimilar Submitted to FDA

Share this content:
Mylan has submitted a biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, to the FDA.
Mylan has submitted a biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, to the FDA.

Mylan has submitted a biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, to the U.S. Food and Drug Administration (FDA). Genentech's trastuzumab is approved by the FDA for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast and gastric cancers.1

This submission is based on findings from the phase 3 HERITAGE study (ClinicalTrials.gov Identifier: NCT02472964), which showed that 69.6% of patients treated with the biosimilar achieved an objective response compared with 64% of patients who received trastuzumab.

Neutropenia was the most frequently reported serious adverse event in both arms; there was no difference in the incidence of cardiac toxicity between the 2 groups.

The study enrolled 500 patients with centrally confirmed, measurable, HER2-positive, metastatic breast cancer who had not received prior chemotherapy or trastuzumab for metastatic disease. Participants were randomly assigned 1:1 to receive MYL1401O or trastuzumab, both in combination with docetaxel or paclitaxel for at least 8 cycles.

RELATED: FCGR3A-158 Polymorphism Predictive of Trastuzumab Efficacy in Breast Cancer

A biosimilar agent is a biologic product that is highly similar to an already approved product with respect to potency, safety, and purity. No biosimilars are approved for the treatment of cancer in the United States, though filgrastim-sndz is approved as a biosimilar to filgrastim for the treatment of neutropenia.                       

Reference

  1. Mylan and Biocon announce U.S. FDA submission for proposed biosimilar trastuzumab. Mylan website. http://newsroom.mylan.com/2016-11-08-Mylan-and-Biocon-Announce-U-S-FDA-Submission-for-Proposed-Biosimilar-Trastuzumab. Updated November 8, 2016. Accessed November 9, 2016.

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs

Sign Up for Free e-newsletters