FDA/EMA Fast-Track Approvals Accelerate Lung Cancer Drug Launches: 15 New Therapies Expected by 2028, Market Report Reveals

Regulatory agencies like the FDA and EMA are accelerating approvals for lung cancer therapies, driven by urgent unmet needs and advancements in real-world evidence (RWE). These policy shifts are reshaping the market, reducing time-to-market for new drugs and encouraging innovation in underserved subtypes. The Lung Cancer Therapeutics Market, valued at $35 billion in 2023, is set to welcome 15 new therapies by 2028, according to Market Research Future’s analysis.

The FDA’s Breakthrough Therapy Designation (BTD) and EMA’s Conditional Marketing Authorization (CMA) have shortened approval timelines. Amgen’s Lumakras (KRAS G12C inhibitor), granted BTD, received approval in 6 months (vs. 18-month average). Similarly, Mirati Therapeutics’ Adagrasib (another KRAS G12C drug) used RWE from patient registries to secure FDA approval, cutting trial time by 12 months. EMA’s CMA for SCLC drugs (e.g., Xentrika’s lurbinectedin) allows early access pending full data, benefiting patients in regions with slower approval processes.

Challenges persist, however. For rare subtypes, collecting sufficient data is tough; SCLC requires at least 100 patients per trial, but global annual cases are just ~200,000, limiting recruitment. Biosimilars face stricter comparability requirements, delaying entry—even as generics flood chemo markets, PD-1 biosimilars take 2-3 years longer to approve. Regional inconsistencies (EMA’s focus on toxicity vs. FDA’s survival metrics) complicate global launches, forcing firms to tailor strategies per region.

These regulatory shifts will continue to drive market growth. By 2028, 15 new drugs—including KRAS G12C inhibitors, STING agonists, and bispecific antibodies—are expected, expanding the therapeutic landscape. Pharma firms are adapting by prioritizing BTD/CMA applications and investing in RWD platforms (e.g., Flatiron Health’s oncology database). For stakeholders, understanding these policies is key to aligning R&D and market entry. Market Research Future’s Regulatory Environment in Lung Cancer Therapeutics Market report, available here, details approval processes, policy impacts, and strategies to navigate regulatory landscapes.