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FDA Grants Breakthrough Status to New Cancer Therapies

10/2/2025

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Summary

Story summary

The U.S. Food and Drug Administration (FDA) granted breakthrough therapy designations to Zongertinib and olomorasib for specific lung cancers.
GLSI-100 received fast track designation for HER2-positive breast cancer, speeding access to therapy.
Intensity Therapeutics Inc. began a Phase 2 European trial of INT230-6 for early-stage breast cancer.
FDA approved new denosumab biosimilars, expanding options for osteoporosis and cancer-related bone loss.

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Story summary

The U.S. Food and Drug Administration (FDA) granted breakthrough therapy designations to Zongertinib and olomorasib for specific lung cancers.
GLSI-100 received fast track designation for HER2-positive breast cancer, speeding access to therapy.
Intensity Therapeutics Inc. began a Phase 2 European trial of INT230-6 for early-stage breast cancer.
FDA approved new denosumab biosimilars, expanding options for osteoporosis and cancer-related bone loss.