Biosimilar Equivalent to Pegfilgrastim for Chemo-induced Neutropenia Prophylaxis

Share this content:
MYL-1401H is equivalent in efficacy to pegfilgrastim for the prevention of chemotherapy-induced neutropenia among patients with breast cancer.
MYL-1401H is equivalent in efficacy to pegfilgrastim for the prevention of chemotherapy-induced neutropenia among patients with breast cancer.

MYL-1401H, a biosimilar product, is equivalent in efficacy to its reference product, pegfilgrastim, for the prevention of chemotherapy-induced neutropenia among patients with breast cancer, according to a study presented at the European Society for Medical Oncology (ESMO) 2016 Congress.1           

For the multicenter, double-blind, phase 3 trial (EudraCT Number: 2014-002324-27), investigators enrolled 194 patients with newly diagnosed stage II or III breast cancer eligible to receive a chemotherapy regimen of docetaxel, doxorubicin, and cyclophosphamide every 3 weeks for 6 cycles.

Participants were randomly assigned 2:1 to receive either the biosimilar or the reference product on day 2 of each cycle.

The average duration of severe neutropenia during cycle 1 was 1.2 ± 0.93 days with MYL-1401H compared with 1.2 ± 1.10 with pegfilgrastim, suggesting that the biosimilar product is equivalent to pegfilgrastim.

The rates of grade 3 to 4 neutropenia, time to absolute neutrophil count nadir, and duration of post-nadir recovery were similar between treatment arms. The safety profiles of both agents were similar and toxicities were manageable. The most common treatment-related adverse event in both groups was bone pain.

RELATED: Q&A: With Dr Anna Boltong: The Link Between Alcohol and Breast Cancer

The European Medicines Agency has accepted a regulatory submission for MYL-1401H for review, though it is unclear if developers Mylan and Biocon will submit a Therapeutic Biologic Application for the biosimilar product to the U.S. Food and Drug Administration.                            

Reference

  1. Waller CF, Blakeley C, Pennella E, et al. Phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H vs EU-neulasta in the prophylaxis of chemotherapy-induced neutropenia. Paper presented at: European Society for Medical Oncology (ESMO) 2016 Congress; October 7-11, 2016; Copenhagen, Denmark.

Related Resources

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

Sign Up for Free e-newsletters



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