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21-09-2017 | FDA | Drug approval | News


Bevacizumab biosimilar approved in USA


medwireNews: Following a positive decision by the US FDA, a bevacizumab biosimilar – bevacizumab-awwb – is now available for the treatment of various cancers.

The agent is the first biosimilar to be approved in the oncology setting in the USA, and can be used for the following indications:

  • First- or second-line treatment of metastatic colorectal cancer (CRC); to be given alongside 5-fluorouracil-based chemotherapy.
  • Second-line therapy of metastatic CRC that has progressed after first-line treatment with regimen containing a bevacizumab product; to be given together with chemotherapy containing fluoropyrimidine–irinotecan or fluoropyrimidine–oxaliplatin.
  • First-line treatment of inoperable, locally advanced, recurrent, or metastatic nonsquamous non-small-cell lung cancer; alongside carboplatin and paclitaxel.
  • Glioblastoma that has progressed after previous treatment, based on improvement in objective response rate.
  • Metastatic renal cell carcinoma; in combination with interferon α.
  • Persistent, relapsed, or metastatic cervical cancer; to be given in combination with paclitaxel plus cisplatin or topotecan.

The announcement specifies that bevacizumab-awwb is not indicated for the adjuvant treatment of patients with surgically resected CRC and highlights the lack of data in the glioblastoma setting showing improvement in disease-related symptoms or survival with bevacizumab products.

Similar to the reference product, bevacizumab-awwb carries a Boxed Warning regarding an increased risk for gastrointestinal perforations, surgery and wound healing complications, and severe or fatal hemorrhage. Healthcare professionals are asked to report any serious adverse events considered related to the drug to the FDA’s MedWatch Reporting System.

By Shreeya Nanda

medwireNews is an independent medical news service provided by Springer Healthcare. © 2017 Springer Healthcare part of the Springer Nature group