FDA Accepts BMY's NDA for Iberdomide Combo in Multiple Myeloma

Core Insights - Bristol Myers Squibb (BMY) has received FDA acceptance for the new drug application (NDA) of iberdomide, in combination with daratumumab and dexamethasone, for treating relapsed or refractory multiple myeloma (RRMM) [1][7] - The FDA has granted a priority review for the NDA, with a decision expected on August 17, 2026 [1] - Iberdomide is part of a new class of drugs known as cereblon E3 ligase modulators (CELMoDs), which are under investigation for RRMM treatment [2][8] BMY's Price Performance - Over the past six months, BMY shares have increased by 24.8%, outperforming the industry average rise of 21.4% [3] Iberdomide Development - The NDA filing is based on data from the phase III EXCALIBER-RRMM study, which showed a statistically significant improvement in minimal residual disease (MRD) negativity rates compared to the control arm [4][7] - The study is ongoing, with patients being assessed for progression-free survival [5] Regulatory Designations - Iberdomide has received Breakthrough Therapy designation from the FDA for the treatment of RRMM [2][7] - The review process is part of the FDA's Project Orbis initiative, allowing simultaneous evaluation by regulatory authorities in other countries [8] Strategic Focus - The successful development of iberdomide and other key pipeline candidates is crucial for Bristol Myers as it aims to expand and diversify its portfolio amid challenges from generic competition [9]