Osimertinib is a tyrosine kinase inhibitor marketed as Tagrisso for EGFR-mutated non-small cell lung cancer. It is used across adjuvant, locally advanced unresectable, and metastatic first-line settings, including combination regimens with platinum-pemetrexed chemotherapy. The FDA first approved it in November 2015.
The FDA approved once-monthly subcutaneous amivantamab with lazertinib for first-line EGFR-mutated advanced NSCLC. PALOMA-2 showed high response rates and no new safety signals.
FDA has cleared a robotic nipple-sparing mastectomy platform after clinical trials showed excellent results with preserved breast sensation. Researchers are advancing immunotherapy combinations for breast cancer and novel strategies to overcome drug resistance in EGFR-mutated lung cancer, including protein degraders and dual-binding inhibitors.
The phase III TOP study shows osimertinib plus chemotherapy more than doubles progression-free survival to 34 months versus 15.6 months with osimertinib alone in EGFR/TP53 mutant NSCLC. The combination achieved an 82.9% response rate and represents a new strategy for this high-risk subgroup. Research continues into resistance mechanisms, including cancer-associated fibroblasts' role in promoting osimertinib resistance.
The FDA approved subcutaneous amivantamab for EGFR-mutated NSCLC in December 2025 based on phase 3 PALOMA-3 trial data showing noninferior efficacy with reduced infusion reactions and 5-minute administration time. The formulation decreases infusion-related reactions from 66% to 13% and improves patient convenience and quality of life. Recent MARIPOSA trial updates show amivantamab plus lazertinib extends median overall survival by at least 12 months versus osimertinib monotherapy.
Summit Therapeutics will participate in three investor conferences in March 2026, following FDA acceptance of its BLA for ivonescimab in lung cancer with a PDUFA date of November 14, 2026.
The FDA approved a once-monthly dosing schedule for Rybrevant Faspro with Lazcluze for first-line treatment of EGFR-mutated advanced NSCLC, reducing clinic visits while maintaining safety and efficacy established with bi-weekly dosing.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07535437 |
A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer |
RECRUITING | PHASE1/PHASE2 |
| NCT07491211 |
Osimertinib Combined With Intracranial SRT for EGFR-Mutant NSCLC With Symptomatic Brain Metastases |
ACTIVE_NOT_RECRUITING | |
| NCT07376382 |
A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC |
NOT_YET_RECRUITING | PHASE3 |
| NCT07375316 |
A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC Patients With Positive ctDNA After lead-in Osimertinib Monotherapy |
RECRUITING | PHASE2 |
| NCT07363252 |
Investigation of REcurrence Mechanisms to Adjuvant osimertINib in Radically Resected EGFR-mutated NSCLC Patients |
RECRUITING | |
| NCT07329322 |
Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib or Sacituzumab Tirumotecan for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer |
RECRUITING | PHASE2 |
| NCT07323641 |
Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer |
RECRUITING | PHASE2 |
| NCT07315113 |
Study of NXP900 With Osimertinib in Subjects With Advanced, EGFR-Mutated Non-Small Cell Lung Cancer |
RECRUITING | PHASE1 |
| NCT07295821 |
Osimertinib Induction and Maintenance for Chemo-ineligible Stage III Unresectable EGFR+ NSCLC: Single-arm Study |
RECRUITING | PHASE2 |
| NCT07256509 |
A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resectable Non-squamous Non-small Cell Lung Cancer |
NOT_YET_RECRUITING | PHASE2 |
