Genentech

SEP 8, 2026 · PHASE 1 TRIAL

To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer

ClinicalTrials.gov

This is a Phase 1 safety and pharmacokinetics study registration with no results posted; it describes planned enrollment and design only, typical of early-stage clinical development.

AUG 17, 2026 · PHASE 3 TRIAL

A Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes of Giredestrant in Participants With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy (novERA Breast Cancer)

ClinicalTrials.gov

This is a Phase 3 trial registration with no results posted; the study is actively recruiting and primary outcomes have not yet been assessed.

AUG 10, 2026 · PHASE 1/2 TRIAL

A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer

ClinicalTrials.gov

This is a Phase 1b/2 trial registration with no results posted; the study is actively recruiting and designed to evaluate safety and efficacy of a novel agent in combination therapy for ER+/HER2− breast cancer.

JUN 10, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Enspryng (Manufacturing (CMC))

U.S. Food and Drug Administration

FDA supplemental approval for manufacturing changes to an approved drug; does not report clinical efficacy or trial outcomes.

MAY 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Herceptin Hylecta (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling of Herceptin Hylecta; this is a regulatory action record, not a clinical evidence trial.

MAY 15, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Tecentriq Hybreza (Efficacy)

U.S. Food and Drug Administration

FDA supplemental approval for a fixed-dose combination formulation; regulatory action does not itself report clinical trial efficacy data or comparative outcomes.

MAR 26, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Kadcyla (Labeling)

U.S. Food and Drug Administration

This is an FDA supplemental approval action for labeling of an already-approved drug; it documents a regulatory decision, not clinical trial evidence or efficacy data.