Vegzelma

RSS

bevacizumab

Authorised
This medicine is authorised for use in the European Union.

Overview

Vegzelma is a cancer medicine used to treat adults with the following types of cancer, in combination with other cancer medicines:

  • cancer of the colon (large intestine) or rectum that is metastatic (has spread to other parts of the body), in combination with chemotherapy medicines that include a ‘fluoropyrimidine’;
  • metastatic breast cancer, in combination with paclitaxel or capecitabine;
  • advanced non-small cell lung cancer in patients whose cancer cells are not mainly of the squamous type, where it is given with platinum-based chemotherapy;
  • advanced non-small cell lung cancer in patients whose cancer cells have a certain change (‘activating mutations’) in the gene for a protein called EGFR, where it is given in combination with erlotinib;
  • advanced or metastatic kidney cancer, in combination with interferon alfa-2a;
  • epithelial cancer of the ovary, cancer of the fallopian tube (that connect the ovaries to the womb) or the peritoneum (the membrane lining the abdomen). Vegzelma is used in combination with certain chemotherapy medicines in newly diagnosed patients when the cancer is advanced, or in previously treated patients whose cancer has come back (recurrent);
  • cancer of the cervix (the neck of the womb) that is persistent, recurrent or metastatic. Vegzelma is given in combination with paclitaxel and either the platinum-based medicine cisplatin or, if this cannot be used, another chemotherapy medicine, topotecan.

Vegzelma is a ‘biosimilar medicine’. This means that Vegzelma is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Vegzelma is Avastin. For more information on biosimilar medicines, see here.

Vegzelma contains the active substance bevacizumab.

This EPAR was last updated on 26/09/2022

Authorisation details

Product details
Name
Vegzelma
Agency product number
EMEA/H/C/005534
Active substance
bevacizumab
International non-proprietary name (INN) or common name
bevacizumab
Therapeutic area (MeSH)
  • Colorectal Neoplasms
  • Breast Neoplasms
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Peritoneal Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Uterine Cervical Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XC07
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

BiosimilarBiosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Publication details
Marketing-authorisation holder
Celltrion Healthcare Hungary Kft.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
17/08/2022
Contact address

Vaci ut 1-3
WestEnd Office Building B torony
1062 Budapest
Hungary

Product information

22/09/2022 Vegzelma - EMEA/H/C/005534 - N/0001

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

VEGZELMA in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.

VEGZELMA in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1.

VEGZELMA in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with VEGZELMA in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1.

VEGZELMA, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer (NSCLC) other than predominantly squamous cell histology.

VEGZELMA, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent NSCLC with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1).

VEGZELMA, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.

VEGZELMA, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1).

VEGZELMA, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor–targeted agents.

VEGZELMA in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents (see section 5.1).

VEGZELMA, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).

Assessment history

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