Boruzu Approved by FDA For Multiple Myeloma, Mantle Cell Lymphoma

The Food and Drug Administration (FDA) has approved Boruzu (bortezomib injection), a new presentation of Velcade (bortezomib), for ready-to-use subcutaneous (under the skin) or intravenous (IV) administration for the treatment of multiple myeloma and mantle cell lymphoma.

The approval was announced by manufacturer Amneal Pharmaceuticals, Inc. and developer Shilpa Medicare Limited, who stated in a news release that this product reduces the compounding preparation steps typically required for administration. Velcade is a powder requiring reconstitution before use, according to the news release, which stated that Boruzu is expected to launch in the second quarter of 2025.

“These ready-to-use injectable presentations are important innovations for oncology providers as they reduce the pharmacy preparation steps for clinicians. We look forward to bringing more branded oncology products to the market for providers while expanding access for patients,” said Sean McGowan, vice president, biosimilars and branded Oncology at Amneal Pharmaceuticals, noting that this is the fourth such injectable treatment approved by the company this year.

Boruzu is a proteasome inhibitor, a type of drug that, according to the National Cancer Institute, blocks the action of proteasomes, a large protein complex that works to destroy other cellular proteins when they are no longer needed.

“This second [new drug application] 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. This development exemplifies Shilpa’s constant endeavor to work towards introducing novel first-of-its-kind pharmaceutical products that help improve the health care requirements of a large patient pool,” said Vishnukant Bhutada, managing director of Shilpa Medicare, in the news release.

The most common side effects for Boruzu in clinical studies, according to the news release, include asthenic conditions (weakness or lack of energy or strength), diarrhea, nausea, constipation, peripheral neuropathy (tingling or numbness in the hands or feet), vomiting, pyrexia (fever), thrombocytopenia (low levels of platelets), psychiatric disorders, anorexia and decreased appetite, neutropenia (low counts of neutrophils, a type of white blood cell), neuralgia (nerve pain), leukopenia (low white blood cell count) and anemia (low red blood cells).

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