US patients gain new generic drug option for myeloma treatment
Avenacy launches Bortezomib for Injection for 2 rare cancer types
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Adults in the U.S. now have a new generic drug option — Bortezomib for Injection, an equivalent of the approved medication Velcade (bortezomib) — for the treatment of multiple myeloma and mantle cell lymphoma, two types of rare cancer.
Avenacy announced the U.S. launch of its generic therapy, which began shipping to wholesale partners last week, in a company press release. The developer noted that this is its 28th product launch since the company’s founding in 2023.
Generic medicines are developed to have the same safety, dosage, strength, and therapeutic properties as brand-name therapies, but they usually cost less. According to the company, Bortezomib for Injection will feature differentiated packaging and labeling to ensure accurate medication selection. The generic will be available as a carton of one 3.5 mg single-dose vial, per the company.
The launch “marks expansion of Avenacy’s oncology portfolio, reflecting the Company’s ongoing commitment to supplying high-impact injectable medications,” the release stated.
In multiple myeloma, a type of blood cancer, immune plasma cells in the bone marrow grow out of control in multiple areas of the bone. As cancer cells build up and crowd out healthy cells, they produce abnormal proteins that can damage bones and kidneys and weaken the immune system. Myeloma often leads to anemia, marked by low red blood cell counts, for patients.
Mantle cell lymphoma is a rare, generally aggressive subtype of non-Hodgkin lymphoma that develops from white blood cells called lymphocytes in lymph nodes. This cancer can also affect the blood, bone marrow, and other tissues throughout the body.
Bortezomib used for over two decades as myeloma treatment
Bortezomib works by blocking the proteasome, a protein complex within cells that degrades damaged or misfolded proteins. By disrupting this function, the therapy causes proteins to accumulate within the cancer cells, leading to cellular stress and cell death.
Velcade is a formulation of bortezomib first approved in 2003 for refractory, or difficult-to-treat, multiple myeloma, then later as a first-line myeloma therapy. It’s also used in people with mantle cell lymphoma and is part of several treatment regimens for various stages of myeloma.
The treatment comes as a powder that must be dissolved in a liquid before it can be administered to patients via subcutaneous (under-the-skin) injections or intravenous (into-the-vein) injections. Several Velcade generics have already been approved in the U.S.
One such generic is Boruzu, a ready-to-use injectable formulation of bortezomib approved by the U.S. Food and Drug Administration in 2024 for adults with multiple myeloma and mantle cell lymphoma. As with Velcade, Boruzu can be administered subcutaneously or intravenously.
Per the prescribing label, Bortezomib for Injection is indicated for the treatment of patients ages 18 and older with multiple myeloma and mantle cell lymphoma. For injection, given subcutaneously or intravenously, each single-dose vial of the new formulation contains 3.5 mg of bortezomib as a sterile, white-to-off-white powder for reconstitution in liquid and withdrawal of the appropriate individual dose.
The therapy should not be used in patients with a history of whole-body allergic reactions to bortezomib, related compounds, or any of its components. Commonly reported side effects with this medication are nausea, diarrhea, fatigue, anemia, constipation, and vomiting. Rash, fever, loss of appetite, reduced blood cell counts, peripheral neuropathy, and nerve pain also commonly occur among patients.
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