Glenmark Pharmaceuticals’ subsidiary, Ichnos Glenmark Innovation (IGI), has received a “fast track” designation from the United States Food and Drug Administration (USFDA) for its investigational therapy, ISB 2001. This therapy is intended for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have previously received at least three therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
ISB 2001 is a tri-specific antibody therapeutic that targets BCMA and CD38 on myeloma cells, as well as CD3 on T cells, enabling a targeted immune response towards the cancer. The therapy is currently undergoing evaluation in a phase 1 dose expansion clinical study. IGI has recently concluded the dose increase portion of its phase 1 clinical study in patients with heavily pre-treated myeloma and plans to present the results from the dose escalation portion at the 2025 American Society of Clinical Oncology (ASCO) annual meeting.
The “fast track” designation from the USFDA is expected to expedite the development and review of ISB 2001, which could potentially lead to earlier approval and availability of the therapy for patients with RRMM. This designation is typically granted to therapies that have shown promise in treating serious or life-threatening conditions with limited treatment options.
In a separate development, Glenmark Pharmaceuticals has initiated a Class-II recall of 39 drugs from its US unit, which was classified as a Class-II recall on April 8, 2025. The recall was initiated in March 2025, and the company is taking steps to address the issue.
The development of ISB 2001 and the “fast track” designation from the USFDA represent a significant milestone for Glenmark Pharmaceuticals and its subsidiary, IGI. The company’s focus on innovation and research is expected to drive growth and expansion in the pharmaceutical industry. With the potential for earlier approval and availability of ISB 2001, patients with RRMM may have access to a new and potentially effective treatment option in the near future.