Glenmark Pharma’s cancer drug receive FDA ‘fast track’ status

6 May 2025 , 09:31 AM

Glenmark Pharmaceuticals announced that its innovation subsidiary, Ichnos Glenmark Innovation (IGI) has received the ‘fast track’ designation to ISB 2001 from United States Food and Drug Administration (USFDA). It is investigational therapy for multiple myeloma.

The drug is used specifically for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three therapies previously. This includes a proteasome inhibitor. It is an immunomodulatory agent and an anti-CD38 monoclonal antibody.

ISB 2001 is a tri-specific antibody therapeutic for targeting BCMA and CD38 on myeloma cells, as well as CD3 on T cells. As per the company, enabling a targeted immune response towards the cancer. The therapy is currently undergoing evaluation in phase 1 dose expansion clinical study.

Ichnos Glenmark Innovation has recently concluded the dose increase portion of its phase 1 clinical study in patients with heavily pre-treated myeloma.

The company will exhibit the results from the dose escalation portion in a rapid oral session at the 2025 American Society of Clinical Oncology (ASCO) at its annual meeting on Monday, June 2, 2025.

The company has recently announced a Class-II recall of 39 drugs from the US unit of the company. The company initiated this recall in March 2025 and was classified as class-II recall on April 8, 2025.

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