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Glenmark Pharma's relapsed cancer drug gets FDA 'fast track' statusInitial study results for ISB 2001, which treats relapsed or refractory multiple myeloma, demonstrated a high overall response rate (ORR) with durable responses and a favourable safety profile. Shares of Glenmark Pharmaceuticals Ltd ended at ₹1,400.30, up by ₹24.65, or 1.79%, on the BSE.By Jomy Jos Pullokaran   May 5, 2025, 6:04:02 PM IST (Updated)2 Min ReadPharma major Glenmark Pharmaceuticals Ltd on Monday (April 5) said its innovation arm, Ichnos Glenmark Innovation (IGI), announced that the US Food and Drug Administration (FDA) has granted ‘fast track’ designation to ISB 2001, its investigational therapy for multiple myeloma.

The designation is specifically for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

ISB 2001 is a tri-specific antibody therapeutic designed to target BCMA and CD38 on myeloma cells, as well as CD3 on T cells, enabling a targeted immune response against the cancer. The therapy is currently undergoing evaluation in a phase 1 dose expansion clinical study.

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Ichnos Glenmark Innovation recently completed the dose escalation portion of its phase 1 clinical study in patients with heavily pre-treated multiple myeloma.

Initial study results, presented in an oral session at the American Society of Hematology (ASH) Annual Meeting in December 2024, demonstrated a high overall response rate (ORR) with durable responses and a favourable safety profile.

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

The FDA’s fast track designation is designed to enable the development and expedite the review of drugs that treat serious conditions and address unmet medical needs, with the ultimate goal of getting important new drugs to patients earlier.

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A drug that receives fast track designation may be eligible for more frequent meetings and communications with the FDA and rolling review of any application for marketing approval.

Further, it may be eligible for priority review if relevant criteria are met. ISB 2001 was previously granted ‘orphan drug’ designation by the FDA in July 2023.

Shares of Glenmark Pharmaceuticals Ltd ended at ₹1,400.30, up by ₹24.65, or 1.79%, on the BSE.

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Continue Reading(Edited by : Shoma Bhattacharjee)First Published: May 5, 2025 6:02 PM ISTCheck out our in-depth Market Coverage, Business News & get real-time Stock Market Updates on CNBC-TV18. Also, Watch our channels CNBC-TV18, CNBC Awaaz and CNBC Bajar Live on-the-go!TagsGlenmark Pharmaceuticalsshare market today