Last Updated on 2026 年 3 月 18 日 by 総合編集組
Lung Cancer Treatment Breakthroughs: 7+ New FDA Approvals and Precision Medicine Advances
In 2025, lung cancer therapy underwent a transformative shift, with multiple landmark FDA approvals reshaping treatment for both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Precision oncology expanded beyond common driver mutations to address rare variants, while antibody-drug conjugates (ADCs) and novel immunotherapies offered new hope for previously resistant cases. This summary highlights key developments, clinical data, and implications for global practice.
NSCLC Targeted Therapies: Expanding Beyond EGFR and ALK
Non-small cell lung cancer accounts for about 85% of cases, and 2025 saw targeted agents tackle hard-to-treat subtypes. Third-generation EGFR TKIs like osimertinib remain first-line standards, with combination regimens (e.g., with platinum-pemetrexed) extending progression-free survival (PFS) in high-burden or brain-metastatic patients.
A major milestone was the July 2025 accelerated approval of Sunvozertinib (Zegfrovy) for EGFR exon 20 insertion mutations after platinum chemotherapy progression. This oral TKI delivered durable objective response rates (ORR) in pretreated patients, marking the first dedicated option for this resistant subtype.
For HER2 (ERBB2) mutations (2-5% of NSCLC), 2025 brought two oral TKIs: Zongertinib (Hernexeos) in August and Sevabertinib (Hyrnuo) in November. Zongertinib, a selective HER2 TKI, showed strong activity across TKD mutations with favorable tolerability compared to ADCs like trastuzumab deruxtecan. These approvals provide convenient oral alternatives, reducing infusion-related risks such as interstitial lung disease.
In ALK fusions (~5%), Ensartinib gained first-line approval in late 2024 with excellent CNS penetration. Lorlatinib remains the go-to for resistant mutations like G1202R. ROS1 fusions saw Taletrectinib (Ibtrozi) approved in June 2025, offering high ORR in treatment-naïve and resistant (e.g., G2032R) patients, plus robust blood-brain barrier penetration.
Rare fusions like NTRK and NRG1 also gained options: larotrectinib/entrectinib for NTRK, and zenocutuzumab for NRG1. MET exon 14 skipping continues with capmatinib as preferred.
ADC Explosion: Precision Delivery for Mutation-Negative or Resistant NSCLC
Antibody-drug conjugates emerged as game-changers in 2025. Datopotamab deruxtecan (Dato-DXd, Datroway) received June approval for EGFR-mutated NSCLC post-TKI and chemo, validating TROP2 targeting. Telisotuzumab vedotin (Emrelis) was approved in May for high c-Met overexpression (IHC ≥50%), shifting paradigms to protein expression-based selection without requiring genetic alterations.
Pipeline highlights include patritumab deruxtecan (HER3-DXd) outperforming chemo in EGFR-resistant settings (PFS ~5.8 months), and the dual EGFR/HER3 ADC BL-BO1D1 achieving 66% ORR and 12.5-month median PFS in heavily pretreated patients. B7-H3 ADCs showed promise in SCLC with ~57% ORR in relapsed cases.
SCLC Revolution: DLL3-Targeted Therapies End Decades of Stagnation
Small cell lung cancer, long limited by rapid resistance, saw breakthroughs via DLL3 targeting (high expression in >80% SCLC, absent in normal tissue). Tarlatamab (Imdelltra), a DLL3 x CD3 bispecific T-cell engager, converted to full FDA approval in November 2025 after DeLLphi-304 confirmed superior ORR (35% vs 20%) and median overall survival (13.6 vs 8.3 months) over topotecan.
Maintenance options advanced with lurbinectedin + atezolizumab approved in October 2025 for extensive-stage SCLC post-induction. Durvalumab consolidation improved outcomes in limited-stage post-chemoradiation.
Immunotherapy Evolution: Combinations, Perioperative Use, and Biomarkers
Dual checkpoint inhibition (PD-1/PD-L1 + CTLA-4) delivered long-term benefits in low PD-L1 NSCLC. Emerging targets like TIGIT continue exploration. Perioperative immunotherapy shifted paradigms, enabling surgery in previously inoperable cases via neoadjuvant approaches.
Subcutaneous formulations of pembrolizumab and nivolumab improved convenience. Biomarkers evolved from PD-L1 to ctDNA/MRD monitoring, where clearance predicts low recurrence risk and guides de-escalation.
Taiwan’s Progressive Policy: Bridging Access Gaps
Taiwan expanded NHI coverage in June 2025 for first-line immunotherapy + anti-angiogenic agents in mutation-negative metastatic non-squamous NSCLC, regardless of PD-L1, benefiting ~1,600 patients annually with up to NT$2 million savings per person. NGS testing has been covered since 2024, prioritizing key drivers.
Future Directions
Post-2025 research focuses on multispecific antibodies, neoantigen vaccines (e.g., LungVax), and engineered cell therapies (TIL/NK) for solid tumors. Pharmacokinetic models optimize ADC delivery, enhancing therapeutic indices.
Overall, 2025 solidified lung cancer as a manageable chronic condition through molecular profiling, novel agents, and policy support—paving the way for curative potential in select cases.
