Press Release

January 03, 2022
1 min read

FDA grants breakthrough therapy status to patritumab deruxtecan for lung cancer subset


Press Release

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The FDA granted breakthrough therapy designation to patritumab deruxtecan for treatment of certain patients with non-small cell lung cancer.

The designation applies to patients with metastatic EGFR-mutated disease.

Sign outside FDA HQ in Washington, DC.
Source: Adobe Stock.

Approximately 30% of patients with NSCLC have EGFR-mutated disease.

Patritumab deruxtecan (HER3-DXd, Daiichi Sankyo) is a HER3-directed antibody-drug conjugate in development for patients with metastatic or locally advanced EGFR-mutated NSCLC who progressed on or after treatment with a third-generation tyrosine kinase inhibitor and platinum-based therapies. Patients who fail EGFR TKIs often receive platinum-based chemotherapy and subsequent salvage therapies, but PFS typically is short.

The FDA based the breakthrough therapy designation on results of a multicenter, open-label phase 1 study designed to evaluate patritumab deruxtecan for patients with metastatic or unresectable NSCLC.

“The breakthrough therapy designation for patritumab deruxtecan acknowledges the need for new treatment approaches to overcome resistance and improve survival in patients with metastatic TKI-resistant, EGFR-mutated non-small cell lung cancer,” Ken Takeshita, MD, global head for research and development with Daiichi Sankyo, said in a company-issued press release. “We look forward to bringing this potential first-in-class HER3-directed antibody drug conjugate to patients with this specific type of lung cancer as quickly as possible.”