Aveed (nda 022219)?

Aveed (177Lu‑PSMA‑I&T)
FDA NDA #022219 – approved March 21 2023

What is Aveed?

Aveed is a targeted radiopharmaceutical that delivers beta‑particle radiation directly to prostate cancer cells that express Prostate‑Specific Membrane Antigen (PSMA). The active compound is an iodine‑tetrasodium (I‑T) chelator that carries the radioactive isotope lutetium‑177 (Lu‑177). When injected, the antibody‑chelator complex binds to PSMA on the cancer cell surface, is internalized, and the Lu‑177 emits beta particles that damage the DNA of the tumor cell while sparing most normal tissues.

Approved Indication

• Metastatic Castration‑Resistant Prostate Cancer (mCRPC)
  • PSMA‑positive disease confirmed by 68Ga‑PSMA PET/CT (or equivalent imaging).
  • Patients who have progressed after, or are intolerant to, at least one taxane‑based chemotherapy (e.g., docetaxel).
  • Must have adequate bone‑marrow reserve (hematologic, hepatic, renal).

How It’s Administered

The drug is prepared at a licensed radiopharmacy and must be handled with standard radiation‑safety precautions. Patients are advised to limit contact with infants and pregnant women for a few weeks after each cycle.

Mechanism of Action (in plain language)

1. Targeting – The antibody part of the drug homes in on PSMA, a protein over‑expressed on most prostate cancer cells.
2. Internalization – Once bound, the complex is taken inside the cancer cell.
3. Radiation delivery – Inside the cell, Lu‑177 emits beta particles that cause double‑strand DNA breaks, leading to cell death.
4. Minimized systemic toxicity – Because the drug concentrates where PSMA is expressed, healthy tissues receive far less radiation.

Key Clinical Trial Findings