Last Updated on September 30, 2024 by The Health Master
CDSCO
CDSCO: Belantamab Mafodotin, a promising medication for relapsed and refractory multiple myeloma, has recently faced scrutiny following the revelation of serious adverse events in the phase-I & II study data.
In this article, we delve into the details of the drug, the study it’s part of, and the recommendations put forth by the Subject Expert Committee (SEC) under the Central Drug Standard Control Organisation (CDSCO).
Introduction
The introduction sets the stage, providing readers with a brief overview of Belantamab Mafodotin and hinting at the challenges it faces due to adverse events in the preliminary study phases.
Study Details
Our exploration then shifts to the phase 3 study, a randomized and open-label examination of Belantamab Mafodotin’s effectiveness when administered in combination with other medications.
A comparative analysis sheds light on the drug’s performance with and without additional treatments.
Adverse Reactions
A critical aspect of any medication is its side effects.
Here, we highlight the common adverse reactions associated with Belantamab Mafodotin, including keratopathy, visual acuity issues, nausea, and more. Understanding these reactions is crucial for both medical professionals and patients.
Mechanism of Action
To comprehend the drug’s impact, we explore its mechanism of action. Belantamab Mafodotin’s anti-BCMA antibody moiety selectively binds to BCMA on tumor cell surfaces.
The subsequent internalization triggers a series of events, leading to G2/M phase arrest and, ultimately, tumor cell apoptosis.
SEC Meeting Details
Transitioning to the CDSCO SEC meeting held on the 6th and 7th of December 2023, we provide an overview of the discussions pertaining to the phase-I Clinical trial, protocol no. 209664.
Committee’s Statement
The committee acknowledged the gravity of the adverse events presented by GSK Pharma and recommended a detailed evaluation.
Furthermore, they insisted on a separate presentation of the toxicity profile concerning Indian subjects.
Further Consideration
In response to the committee’s suggestions, the article discusses the importance of re-deliberating the proposal.
A thorough analysis of adverse events in the ongoing study is deemed necessary for the progression of the drug’s therapeutic cycle.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
NPPA’s Directive: Streamlining Drug Formulation Pricing
Govt Job: For M.Pharm, Pharm.D under (IPC) Indian Pharmacopoeia Commission
UK MHRA’s Revolutionary International Recognition Procedure
Drug recall: Benzocaine Topical Anesthetic Spray recalled Due to this reason
DCA Telangana’s Battle Against Spurious Drugs
USFDA issued Form 483 with 5 observations to Torrent
National Single Window System for Medical Devices
Unveiling the Top 20 Most Expensive Drugs in the World
The Need for Parallel Drug Approval in India: OPPI’s Urgent Plea
National Human Rights Commission’s Inquiry into Medicines Standards
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
