Tag: FDA

Practice-Changing Advances in Early HER2-Positive Breast Cancer: ASCO 2026 and FDA Approvals Establish Trastuzumab Deruxtecan as a New Standard

The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk profile at the proposed dosage of belantamab mafodotin (Blenrep®; GSK) combinations for the treatment of patients diagnosed with multiple myeloma.

Daiichi Sankyo and Merck & CO/MSD have voluntarily withdrawn the Biologics License Application (BLA) seeking accelerated approval in the U.S. for patritumab deruxtecan (HER3-DXd) in patients with previously treated locally advanced or metastatic EGFR-mutated Non-Small Cell Lung Cancer (NSCLC) previously treated with two or more systemic therapies.

The U.S. Food & Drug Administration (FDA) has provided clearance of the Investigational New Drug (IND) application for a Phase 1 Tiffany-01 study (NCT06597721) evaluating ADCE-T02 (previously known as AMT 754; see Drugmap), a novel antibody-drug conjugate being developed by Adcendo.

The U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for BL-M11D1, an antibody-drug conjugate (ADC) binding CD33, a sialic acid-dependent cytoadhesion molecule and a member of the sialic acid-binding immunoglobulin (Ig)-like lectins (Siglecs), which is a subset of the immunoglobulin superfamily molecules.

Following intensified investments, new partnerships, out-licensing ADC assets, and major scientific advances from companies including Bristol Myers Squibb (a US $8.4 billion deal with SystImmune), AstraZeneca (the company signed a US $ 600 million dollar deal to obtain global from LaNova Medicines for pre-clinical ADC candidates), Roche, Lonza, MilliporeSigma, BioNTech (acquired 2 different ADC assets from DualityBio for an upfront payment of US $170 million. The company also obtained a novel ADC HER3 assets from MediLink Therapeutics), Myricx Bio (licensed rights to an antibody discovered by WuXi Biologics),  while GlaxoSmithKline (acquired ex-China rights for B7-H4 ADC from Hansoh Pharma in a $1.57 billion deal, plus royalties on sales), and others, China is expected to drive the next research boom in novel, innovative medicines, like antibody-drug conjugates (ADC).

Required adaptations to clinical trial design and execution, implemented during the COVID-19 pandemic, have put a new focus on the development of patient-focused, decentralized...

The U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for OBI-992 (also known as BSI-992), to conduct a...

Enfortumab vedotin + Pembrolizumab Approved by US FDA as the First and Only ADC + PD-1 Combination to Treat Advanced Bladder Cancer

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ARX517, a proprietary anti-PSMA antibody-drug conjugate (ADC) investigational being therapy developed by Ambrx for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) upon progression on an androgen receptor pathway inhibitor.