Αρχική World News EMA Recommends Granting a Marketing Authorisation for Equidacent

EMA Recommends Granting a Marketing Authorisation for Equidacent

On 23 July 2020, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Equidacent, a biosimilar bevacizumab, intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer (NSCLC), renal cell cancer (RCC), epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

The applicant for this medicinal product is Centus Biotherapeutics Europe Limited.

Equidacent will be available as 25 mg/ml concentrate for solution for infusion. The active substance of Equidacent is bevacizumab, a monoclonal antibody (ATC code: L01XC07) which binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, thereby inhibiting the binding of VEGF to its receptors on endothelial cells. Neutralising the biological activity of VEGF regresses the vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth.

Equidacent is a biosimilar medicinal product. It is highly similar to the reference product Avastin (bevacizumab), which was authorised in the EU on 12 January 2005.

Data show that Equidacent has comparable quality, safety and efficacy to Avastin.

The full indication is:

  • Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.
  • Bevacizumab 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, it should be refered to section 5.1.
  • Bevacizumab 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 Equidacent in combination with capecitabine. For further information as to HER2 status, it should be referred to section 5.1.
  • Bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent NSCLC other than predominantly squamous cell histology.
  • Bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous NSCLC with epidermal growth factor receptor activating mutations (section 5.1).
  • Bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic RCC.
  • Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (section 5.1).
  • Bevacizumab, 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 VEGF inhibitors or VEGF receptor-targeted agents.
  • Bevacizumab, 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 (section 5.1).

Equidacent should be prescribed by physicians experienced in the use of antineoplastic medicinal products.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the European Commission decision, which will normally be issued 67 days from adoption of the opinion.

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