Jazz Pharmaceuticals PLC said on Monday the U.S. Food and Drug Governance approved Roche’s combination therapy of Tecentriq (atezolizumab) and Zybrestat (fosdenopterin) for adults with advanced non-small cell lung cancer whose tumors have EGFR exon 20 insertion mutations. The approval marks a significant advancement for patients with this specific,historically difficult-to-treat form of lung cancer,offering a new targeted treatment option.
Approximately 5-10% of patients with non-small cell lung cancer harbor EGFR exon 20 insertion mutations. These mutations drive cancer growth but are not addressed by existing EGFR inhibitors. The approval of the Tecentriq and Zybrestat combination, following a priority review, provides a much-needed therapy for this patient population, perhaps extending lives and improving quality of life. The therapy’s approval is based on data from the phase 3 MARIPOSA trial, which demonstrated a statistically significant enhancement in progression-free survival compared to chemotherapy.
The FDA granted the combination therapy Breakthrough Therapy designation, Priority review, and Orphan Drug designation.The recommended dosage of Tecentriq is 1200 mg administered intravenously every three weeks, in combination with Zybrestat, taken orally twice daily. Jazz will co-promote the therapy with Roche in the United States.
