Dexamethasone Sodium Phosphate

On October 23, 2025, the Food and Drug Administration approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate, with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.Full prescribing information for Blenrep will be posted on Drugs@FDA.Efficacy was evaluated in DREAMM-7 (NCT04246047), an open-label, randomized, multicenter trial in adults with relapsed or refractory multiple myeloma who had received at least one line of prior therapy. The trial excluded patients who were refractory or intolerant to daratumumab or bortezomib, had received prior BCMA-directed therapy, and had existing corneal disease, except for mild punctate keratopathy.Patients were randomized (1:1) to receive either belantamab mafodotin-blmf, bortezomib, and dexamethasone (BVd) or daratumumab, bortezomib, and dexamethasone (DVd). The efficacy population included 217 patients (108 and 109 in respective arms) who had received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.Efficacy was established based on progression-free survival (PFS) and overall survival (OS). The median PFS was 31.3 months (95% confidence interval [CI]: 23.5, not reached [NR]) in the BVd arm and 10.4 months (95% CI: 7, 13.4) in the DVd arm (hazard ratio [HR] 0.31, 95% CI: 0.21, 0.47). The median OS was NR and 35.7 months (95% CI: 21.1, NR) in respective arms (HR 0.49, 95% CI: 0.32, 0.76).Prescribing information includes a Boxed Warning for the risk of ocular toxicity, including corneal epithelium changes resulting in vision deterioration. Among those receiving belantamab mafodotin-blmf in DREAMM-7, ocular toxicity occurred in 92% of patients, including Grade 3 or 4 in 77%, with 83% requiring dosage modification due to ocular toxicity.Because of the risk of ocular toxicity, belantamab mafodotin-blmf is available only through a Risk Evaluation and Mitigation Strategy (REMS), called the BLENREP REMS. Other Warnings and Precautions include thrombocytopenia and embryo-fetal toxicity.The recommended belantamab mafodotin-blmf dosage is 2.5 mg/kg once every three weeks in combination with bortezomib and dexamethasone for the first eight cycles, followed by belantamab mafodotin-blmf 2.5 mg/kg once every three weeks as a single agent until disease progression or unacceptable toxicity. Prescribing information contains dosing instructions of the drugs administered in combination with belantamab mafodotin-blmf.This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA's assessment.Belantamab mafodotin-blmf received orphan drug designation.Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA's MedWatch Reporting System or by calling 1-800-FDA-1088.For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE's Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.Follow the Oncology Center of Excellence on X: @FDAOncology.

Plus, news about Merck, Beijing Jacobio, Immunai, BridGene Biosciences and Spyre Therapeutics: 🇨🇳 Dianthus Therapeutics licenses autoimmune asset from China: The biotech will pay $30 million upfront to Nanjing Leads Biolabs for its bifunctional BDCA2 and BAFF/APRIL inhibitor. The company plans to start a Phase 1 this year in China in healthy volunteers and patients with systemic lupus erythematosus. The deal also includes up to $8 million in near-term milestones, with a total of $962 million on the table and royalties. — Jaimy Lee 💵 C4 Therapeutics’ $125M offering: The company is selling about 21.9 million shares for $2.22 apiece. RA Capital led the offering. Other investors include OrbiMed and Soleus Capital. Part of the cash will fund trials of cemsidomide, which is being tested in combination with dexamethasone in patients with relapsed/refractory multiple myeloma. — Jaimy Lee 🩺 Merck’s Keytruda combo improves survival odds in ovarian cancer: The KEYNOTE-B96 study tested Keytruda plus chemotherapy, with or without bevacizumab. Merck said the study met the overall survival endpoint in all comers at the final analysis. The trial previously hit its primary endpoint of progression-free survival as well as overall survival in patients whose tumors expressed PD-L1. — Lei Lei Wu 🤝 Oceanpine Capital and unnamed ‘industry partner’ to acquire 80% stake in Beijing Jacobio: The firm is paying RMB 125 million upfront (about $17.5 million) and up to RMB 75 million (about $10.5 million) in milestones. Beijing Jacobio is a subsidiary of Jacobio Pharma. It’s working on cancer drugs. — Jaimy Lee 🧪​ Immunai partners with AstraZeneca on inflammatory bowel disease target: The companies, which first teamed up in 2024, said the undisclosed target was detected by ​Immunai’s AI platform. The drugmaker is now paying up to $85 million for the exclusive rights to any therapies directed at the target. — Jaimy Lee 🔬 BridGene Biosciences raises $28M Series B+: The company plans to use the funding to advance its covalent TEAD inhibitor for solid tumors through Phase 2. It’s also aiming to get a second program into the clinic in 2027. Bayland Capital led the round. — Jaimy Lee 💰 Spyre Therapeutics raised $316 million in its offering, exceeding the $275 million it had targeted. — Jaimy Lee