FDA New Drug Approval Roundup (March 2022)

Pluctivo for PSMA-positive mCRPC

The US Food and Drug Administration has approved ¹⁷⁷Lu-PSMA-617 (Pluctivo; Novartis) for the treatment of patients with metastatic prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) following other therapies. Approval is based on results from the phase 3 VISION trial that demonstrated patients with treated PSMA-positive mCRPC treated with ¹⁷⁷Lu-PSMA-617 in addition to standard of care had a statistically significant reduction in risk of death. (3/23/2022)

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Opdualag for metastatic or unresectable melanoma

The US Food and Drug Administration has approved Opdualag (nivolumab and relatlimab-rmbw; BMS) for the treatment of adult and pediatric patients aged 12 years or older with metastatic melanoma or melanoma which cannot be treated with surgery. Approval is based on results from the phase 2/3 RELATIVITY-047 trial that demonstrated a statistically significant improvement in progression-free survival compared to nivolumab alone. (3/18/2022)

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Ztalmy for the treatment of seizures associated rare form of genetic epilepsy

The U.S. Food and Drug Administration has approved ganaxolone (Ztalmy; Marinus Pharmaceuticals) oral suspension in patients 2 years of age and older for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD). Approval is based on data from the phase 3 Marigold trial which demonstrated patients treated with ganaxolone experienced a significant reduction in major motor seizure frequency. (3/18/2022)

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