Ready-to-use bortezomib formula Boruzu OK’d for multiple myeloma
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The U.S. Food and Drug Administration (FDA) has approved Boruzu, a ready-to-use injectable formulation of bortezomib, for treating adults with multiple myeloma and mantle cell lymphoma.
While a bortezomib formulation sold as Velcade has been used for years for these forms of blood cancer, Boruzu is expected to be more convenient for clinicians by bypassing some of the steps needed to prepare Velcade. The newly approved formulation was developed by Shilpa Medicare Limited and will be manufactured and commercialized by Amneal Pharmaceuticals, with an expected U.S. launch by June 2025.
“These ready-to-use injectable presentations are important innovations for oncology providers as they reduce the pharmacy preparation steps for clinicians,” Sean McGowan, Amneal’s vice president of biosimilars and branded oncology, said in a joint company press release. “We look forward to bringing more branded oncology products to the market for providers while expanding access for patients.”
Bortezomib belongs to an important class of myeloma therapies called proteasome inhibitors. Proteasomes are protein complexes inside cells that break down old or unneeded proteins and recycle them. If the proteasome doesn’t work properly, protein waste accumulates and damages cells.
Bortezomib blocks the activity of 26S proteasomes, leading to toxic protein accumulation and cancer cell death. Myeloma cells are more dependent on 26S proteasomes than healthy cells, which is why the therapy has a greater effect on cancer cells.
How Boruzu differs from Velcade
Velcade, which is marketed by Takeda Pharmaceuticals, is a formulation of bortezomib approved in 2003 for difficult to treat multiple myeloma then later as a first-line myeloma therapy. It’s also used in mantle cell lymphoma and is part of several different treatment regimens used in various stages of myeloma.
The treatment comes as a powder that has to be dissolved in liquid before it can be administered to patients via injections under the skin, that is, subcutaneously, or into the vein, or intravenously. Several generics of Velcade have been approved in the U.S.
Boruzu works the same way as Velcade, but comes as a solution that doesn’t have to be dissolved and prepared before administration, although it may still be diluted in saline to reach the right concentration for dosing. As with Velcade, Boruzu can be given subcutaneously or intravenously, but is expected to offer more convenience for healthcare providers administering it.
Boruzu was approved under the FDA’s 505(b)(2) pathway, which is used to clear new drugs whose active ingredients have been previously approved. The process let developers utilize earlier clinical studies that show bortezomib’s safety and efficacy to support its application without having to conduct additional trials.
“This second … approval in the U.S. market from our novel injectable portfolio is a testament of our capabilities and commitment to introduce pharmacy efficient solutions that enhance preparation and have the potential to reduce patient wait times,” said Vishnukant Bhutada, managing director of Shilpa. “This development exemplifies Shilpa’s constant endeavor to work towards introducing novel first-of-its-kind pharmaceutical products that help improve the healthcare requirements of a large patient pool.”
Per the prescribing label, the most common side effects expected with Boruzu include nausea, diarrhea, reductions in blood cell counts, damage to nerves outside the brain and spinal cord, fatigue, nerve pain, anemia, constipation, vomiting, rash, fever, and loss of appetite. Boruzu shouldn’t be used in patients with a history of whole-body allergic reactions to bortezomib, related molecules, or any of the therapy’s ingredients. It shouldn’t be given via injection into the spinal canal.
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