FDA Approves Boruzu for Subcutaneous, Intravenous Administration for Multiple Myeloma, Mantle Cell Lymphoma

Image Credit: Adobe Stock Images/kamonrat

The FDA has approved Amneal Pharmaceuticals and Shilpa Medicare’s Boruzu (bortezomib) as the first ready-to-use version of bortezomib for subcutaneous (SC) and intravenous administration. Currently, Boruzu is used to treat multiple myeloma and mantle cell lymphoma. According to the companies, the treatment streamlines oncology treatment by reducing the compounding preparation steps required with existing bortezomib products, such as Velcade, which requires reconstitution before use.¹

"We are building a distinct branded oncology injectable portfolio. The approval of Boruzu is our fourth 505(b)(2) injectable approval this year. 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, VP, biosimilars and branded oncology, Amneal Pharmaceuticals, in a press release.

Bortezomib was first approved by the FDA in 2003 as Velcade as an injection treatment for relapsed and refractory multiple myeloma. Under the name Velcade, it was approved in three other indications between 2007 and 2010. Finally in 2012, it was approved for SC administration in all of the previously approved indications.²

In most cases, bortezomib is usually administered twice a week, for two weeks. After a break of 10 days, a patient will continue for up to eight cycles. According to Cancer Research UK, patients will undergo blood or urine tests after four cycles of treatment, continuing treatment if a response is reported.³

Common adverse events (AEs) of bortezomib include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia, and anemia.1 AEs can be different in each patient and may also depend on other treatments that are being administered. Data show that common AEs generally occur in 10% of patients being treated with bortezomib.³

Patients with pre-existing severe neuropathy should be treated with bortezomib only after careful risk-benefit assessment. Additionally, patients should use caution if they are currently taking anti-hypertensives, with a history of syncope, or with dehydration. Other issues that have been reported include worsening of and development of cardiac failure, acute respiratory systems, and a number of other syndromes and conditions.⁴

"This second NDA approval in the US 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 healthcare requirements of a large patient pool," said Vishnukant Bhutada, managing director, Shilpa Medicare, in the press release.

Boruzu was developed by Shilpa, with Amneal responsible for manufacturing and commercialization, and is expected to launch in Q2 of next year. IQVIA states that annual sales for bortezomib in the United States ending in December of last year were approximately $96 million.¹

References

1. Amneal and Shilpa Announce U.S. FDA Approval of BORUZU™, the First Ready-to-Use Version of Bortezomib for subcutaneous administration. Yahoo!finance. September 5, 2024. Accessed September 6, 2024. https://finance.yahoo.com/news/amneal-shilpa-announce-u-fda-200500094.html?guccounter=1

2. Velcade FDA Approval History. Drugs.com. Accessed September 6, 2024. https://www.drugs.com/history/velcade.html

3. Bortezomib (Velcade). Cancer Research UK. Accessed September 6, 2024. https://www.cancerresearchuk.org/about-cancer/treatment/drugs/bortezomib#:~:text=Bortezomib%20is%20a%20type%20of,or%20with%20other%20cancer%20drugs.

4. Bortezomib Prescribing Information. Drugs.com. Accessed September 6, 2024. https://www.drugs.com/pro/bortezomib.html