NEWS DETAIL

  • Source : Press Release
  • Date : 2022-02-09
  • Event type : Marketed
  • Companies : EVER Pharma GmbH

EVER Pharma Receives EU Approval for a Liquid Ready to Use Bortezomib Formulation

EVER Pharma is pleased to announce EU-wide approval of Bortezomib for the treatment of patients with multiple myeloma and mantle cell lymphoma1.

Bortezomib EVER Pharma is an innovative liquid ready to use formulation that offers several advantages over the many powder formulations available on the market. It does not require reconstitution prior to preparation, allowing the safe handling of cytotoxics and improving the economics and efficiency in the preparation. Moreover, no dilution would be needed prior to subcutaneous injection (SC), which is most common route of administration for patients with Multiple Myeloma.

In addition to the standard 3.5mg/1.4ml presentation, the EVER product also adds a new 2.5mg/1ml vial size which covers the most common patient doses for SC injection with minimal wastage.

It is estimated that about 86,000 cases of multiple myeloma occur annually worldwide, accounting for about 0.8% of all new cancer cases. About 63,000 patients are reported to die from the disease each year.

“Bortezomib is an extremely important cancer medication and we are pleased to offer this innovative EVER product. It not only enables safe and efficient patient dose preparation but has the potential to significantly improve access for cancer patients” said Georges Kahwati, General Manager of EVER Pharma.

Further to the European approval of EVER Pharma Bortezomib, EVER Pharma plans to register and launch the product in major markets around the world.

1. Bortezomib EVER Pharma is indicated:

As monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.

In combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.

In combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.

In combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

Multiple myeloma is a cancer that forms in a type of white blood cell called a plasma cell. Normal plasma cells help fight infections by making antibodies against the infection. In multiple myeloma, cancerous plasma cells accumulate in the bone marrow and crowd out healthy blood cells. Rather than produce helpful antibodies, the cancer cells produce abnormal proteins that can cause complications.