FDA Accepts Biologics License Application for Proposed Biosimilar Trastuzumab

Share this content:
The FDA has accepted Mylan's Biologics License Application (BLA) for MYL-1401O.
The FDA has accepted Mylan's Biologics License Application (BLA) for MYL-1401O.

The U.S. Food and Drug Administration (FDA) has accepted Mylan's Biologics License Application (BLA) for MYL-1401O, a proposed biosimilar to branded trastuzumab (Herceptin), a human epidermal growth factor receptor 2 (HER2)/neu receptor antagonist indicated for the treatment of HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma.1

The BLA submission is based on findings from the multicenter, double-blind, phase 3 HERITAGE trial (ClinicalTrials.gov Identifier: NCT02472964), which evaluated the efficacy and safety of MYL-1401O plus paclitaxel or docetaxel compared with trastuzumab plus a taxane in 458 treatment-naive women with ERBB2 (HER2)-positive metastatic breast cancer.

Results of the study showed that 69.6% (95% CI, 63.62-75.51) of patients who received the proposed biosimilar achieved a response by week 24 compared with 64.0% (95% CI, 57.81-70.26) of those given trastuzumab.

There was no statistically significant difference in progression-free survival, time to tumor progression, or overall survival between the 2 treatment arms at week 48.

RELATED: Biosimilar to Trastuzumab Has Equivalent Activity in Breast Cancer

The safety profiles of the 2 agents were similar, with the most frequently reported adverse events being neutropenia, peripheral neuropathy, and diarrhea.

The FDA is expected to take action on the BLA by September 3, 2017. If approved, MYL-14010 could be the first biosimilar trastuzumab in the US.

Reference

  1. U.S. FDA accepts Biologics License Application (BLA) for Mylan and Biocon's proposed biosimilar trastuzumab. Mylan website. http://newsroom.mylan.com/2017-01-11-U-S-FDA-Accepts-Biologics-License-Application-BLA-for-Mylan-and-Biocons-Proposed-Biosimilar-Trastuzumab. Published January 11, 2017. Accessed January 11, 2017.

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