FDA clears text

DeltaRex-G Secures FDA Authorization as Adjuvant Therapy For TNBC

June 29, 2021

An investigational gene therapy for treatment of triple negative breast cancer (TNBC) developed by the Aveni Foundation and the Cancer Center of Southern California has received FDA authorization as first-line therapy for patients suffering from early-stage disease.

DeltaRex-G was cleared for use under the FDA’s Right to Try program which allows patients to use investigational new drugs and biologics outside of clinical trials.

DeltaRex-G is a tumor-targeted gene therapy that works by starving tumors of their blood supply and destroying cells that build into tumors.

The authorization was supported by results from several early- and mid-stage trials showing the drug had minimal toxicity and could be effective in prolonging life for Stage 4 TNBC patients.

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