---
title: "FDA approves Zenbexus (iberdomide) for multiple myeloma, first of a novel drug class"
id: "stat-news-1-stat-fda-approves-bristol-multiple-myeloma-treatment-marking-debut-of-novel"
canonical_url: "https://medichelpline.com/clinical-feed/stat-news-1-stat-fda-approves-bristol-multiple-myeloma-treatment-marking-debut-of-novel"
content_type: "clinical_feed_article"
specialty: "Oncology"
source_name: "STAT News"
source_url: "https://www.statnews.com/2026/08/14/fda-approves-bristol-multiple-myeloma-drug-zenbexus/?utm_campaign=rss"
published_at: "2026-08-14T12:03:41.000Z"
evidence_level: "Verified Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# FDA approves Zenbexus (iberdomide) for multiple myeloma, first of a novel drug class
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/stat-news-1-stat-fda-approves-bristol-multiple-myeloma-treatment-marking-debut-of-novel
- **Specialty:** [Oncology](https://medichelpline.com/clinical-feed/oncology.md)
- **Primary Source:** STAT News
- **Source URL:** [Original Journal Publication](https://www.statnews.com/2026/08/14/fda-approves-bristol-multiple-myeloma-drug-zenbexus/?utm_campaign=rss)
- **Published At:** 2026-08-14T12:03:41.000Z
- **Evidence Rating:** Verified Feed
## Executive GIST (TL;DR)
- The FDA approved an oral treatment for advanced **multiple myeloma** developed by Bristol Myers Squibb: **iberdomide**, to be marketed as **Zenbexus**. - Zenbexus is authorized for use in combination with Darzalex (daratumumab) and dexamethasone in patients who have received at least one prior line of therapy. - The approval represents the debut of a **novel class of drugs** for multiple myeloma, according to the reporting. - The FDA clearance was also notable because it is the first U.S. approval that relied on a **more sensitive measure of remission**; the article states Zenbexus is the first drug cleared using that measure. - Bristol’s chief medical officer Cristian Massacesi commented that the approval opens opportunities for additional combinations using the new drug class. - The report was published by Adam Feuerstein for STAT on Aug. 14, 2026; substantial portions of the original article are behind the STAT+ paywall and were not available in the provided source text. - Details such as clinical trial results, safety profile, exact indications beyond the regimen and prior-line requirement, and data supporting the regulatory decision were not reported in the accessible portion of the source. - The article notes the approval is an important regulatory and commercial milestone for Bristol Myers Squibb and for the treatment landscape of this blood cancer.
## Clinical Analysis & Structured Key Points
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Test your knowledge with our new weekday mini crossword [ Start solving ](https://www.statnews.com/stat-mini-crossword/) [STAT Plus](https://www.statnews.com/stat-plus/)[Biotech](https://www.statnews.com/category/biotech/) # FDA approves Bristol multiple myeloma treatment, marking debut of novel drug class ## Zenbexus is also first drug cleared using more sensitive measure of cancer remission * [Manage alerts for this article](https://www.statnews.com/my-account/edit/#emails) * Email this article * [Share this article](https://www.statnews.com/2026/08/14/fda-approves-bristol-multiple-myeloma-drug-zenbexus/?utm_campaign=rss) ![malignant plasma cells of multiple myeloma](https://www.statnews.com/wp-content/uploads/2022/12/AdobeStock_251916311-645x645.jpeg) Bone marrow aspirate cytology of multiple myeloma.Adobe ![](https://www.statnews.com/wp-content/uploads/2021/02/adam-f-avatar-small2-80x80.png) By [Adam Feuerstein](https://www.statnews.com/staff/adam-feuerstein/) Aug. 14, 2026 Adam Feuerstein, a senior writer and biotech columnist, is the author of [Adam’s Biotech Scorecard](https://www.statnews.com/signup/scorecard/), a subscriber-only newsletter about the crossroads of drug development, business, Wall Street, and biotechnology. ![](https://www.statnews.com/wp-content/uploads/2021/02/adam-f-avatar-small2-80x80.png) [Adam Feuerstein](https://www.statnews.com/staff/adam-feuerstein/) 1. [](https://x.com/adamfeuerstein "X") adam.feuerstein@statnews.com Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast [The Readout Loud](https://www.statnews.com/category/readout-loud/) and author of the newsletter [Adam’s Biotech Scorecard.](https://www.statnews.com/signup/scorecard/) You can reach Adam on Signal at stataf.54. The Food and Drug Administration on Thursday approved an oral treatment for advanced multiple myeloma made by Bristol Myers Squibb, marking the debut of a new class of medicine for the blood cancer and the first drug cleared by U.S. regulators using a more sensitive measure of remission. The Bristol drug, iberdomide, will be sold under the brand name Zenbexus. It will be used in combination with two other drugs, Darzalex and dexamethasone, to treat patients with multiple myeloma who have received at least one prior line of therapy. Advertisement “With the Zenbexus approval, Bristol is the first company to bring a novel class of drugs to patients with multiple myeloma, opening venues for many more potential combinations,” said Cristian Massacesi, Bristol’s chief medical officer, in an interview with STAT ahead of the approval announcement. [![STAT+](https://www.statnews.com/wp-content/themes/stat/images/stat-plus-logo.svg)](https://www.statnews.com/stat-plus/) To read the rest of this story subscribe to STAT+. [Subscribe](https://www.statnews.com/stat-plus/) [Log In](https://www.statnews.com/login/) [biotechnology](https://www.statnews.com/topic/biotechnology/), [Bristol Myers Squibb](https://www.statnews.com/topic/bristol-myers-squibb/), [Cancer](https://www.statnews.com/topic/cancer/), [drug development](https://www.statnews.com/topic/drug-development/), [Pharmaceuticals](https://www.statnews.com/topic/pharmaceuticals/), [STAT+](https://www.statnews.com/topic/stat-plus/) [Submit a correction request](https://www.statnews.com/contact/?how_can_we_help_=Editorial%20Correction%20Request)[Reprints](https://www.parsintl.com/publications/stat/) 1. ![](https://www.statnews.com/wp-content/uploads/2021/02/adam-f-avatar-small2-80x80.png) [Adam Feuerstein](https://www.statnews.com/staff/adam-feuerstein/) 1. [](https://x.com/adamfeuerstein "X") 2. Senior Writer, Biotech 1. [](https://x.com/adamfeuerstein "X") 2. Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast [The Readout Loud](https://www.statnews.com/category/readout-loud/) and author of the newsletter [Adam’s Biotech Scorecard.](https://www.statnews.com/signup/scorecard/) You can reach Adam on Signal at stataf.54. ![](https://www.statnews.com/wp-content/themes/stat/images/article-new/envelope-open.svg) ![](https://www.statnews.com/wp-content/uploads/2024/03/Biotech-Scorecard-Logo-NoSTAT-640x290.png) ### STAT+ Newsletter Senior writer Adam Feuerstein's unfiltered, uncompromising analysis on the biotech world Please enter a valid email address. Sign Up Your data will be processed in accordance with our [Privacy Policy](https://www.statnews.com/privacy/) and [Terms of Service](https://www.statnews.com/terms-conditions/). You may opt out of receiving STAT communications at any time. 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