View source for VAL-083 (Dianhydrogalactitol)

{{TreatmentInfo
|drug_name=VAL-083 (Dianhydrogalactitol)
|FDA_approval=Approved in China for CML and lung cancer; not yet approved outside of China for GBM
|used_for=Recurrent Glioblastoma Multiforme (GBM) with unmethylated MGMT promoter
|clinical_trial_phase=Phase 2 (ongoing evaluation in GBM AGILE for various GBM subtypes)
|common_side_effects=Myelosuppression, including neutropenia and lymphopenia; some instances of serious adverse events possibly related to VAL-083
|OS_without=Historical mOS for similar patient population using lomustine is 7.2 months
|OS_with=8.0 months mOS observed in phase 2 trial for patients receiving treatment dose of 30 mg/m2/day
|PFS_without=Not specified
|PFS_with=Not fully established from available data
|usefulness_rating=Pending further clinical trials
|usefulness_explanation=Shows potential for treating recurrent GBM, especially in specific genetic profiles like unmethylated MGMT promoter. Comparative mOS suggests potential improvement over lomustine.
|toxicity_level=3
|toxicity_explanation=The most common adverse event reported is myelosuppression, including instances of neutropenia and lymphopenia. A few patients experienced serious adverse events possibly related to VAL-083, indicating a moderate toxicity profile. Ongoing monitoring and management of these side effects are essential to minimize risks to patients.
|book_text=VAL-083 represents an innovative approach to treating recurrent GBM, leveraging a unique mechanism of action that differs from other alkylating agents. Its effectiveness in patients with specific genetic markers, such as an unmethylated MGMT promoter, underscores the importance of targeted genetic testing in guiding GBM treatment. Further studies are crucial to confirm these preliminary findings and fully establish VAL-083's therapeutic potential and safety profile in GBM treatment.
|treatment_category=Other chemotherapy agents at recurrence
}}