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Biologics are Taking Centre Stage: ADCs, Bispecifics, Cell & Gene Therapies
In recent years, a pattern has emerged in the approval ledger: biologics are closing the gap on small molecules in annual approvals. Antibody–drug conjugates (ADCs) led the category. Datopotamab deruxtecan (Dato-DXd) emerged as the first TROP-2-targeted ADC for breast cancer, while telisotuzumab vedotin broke fresh ground by tackling c-MET–positive non-small cell lung cancer [5,6]. Together with other impressive readouts, these approvals confirm that ADCs have moved beyond experimental status to become a robust platform for biomarker-guided cancer treatment.
Bispecific antibodies also made headway in 2025. Tarlatamab achieved full approval for extensive-stage small cell lung cancer that has progressed after platinum chemotherapy [7]. Its single-agent potency in one of the most immunologically “cold” solid tumours underscored the expanding reach of bispecifics, and their ability to spark immune responses where other modalities fall short.
Cell- and gene-based therapies, while facing market turbulence in 2025, continued to advance. Breyanzi secured the first CAR-T indication for relapsed or refractory marginal zone lymphoma, indicating continued regulatory confidence in these products [8]. At the same time, several ex vivo CRISPR-edited T-cell therapies moved through clinical pipelines. Although several large pharmaceutical companies notably exited the space in 2025, improvements in gene-editing tools and manufacturing platforms suggest this class will continue to gain ground as both a market and a source of innovation.
What links these biologic approaches is precision: each is engineered to home in on tumours, and act directly in the tumour micro-environment, sparing healthy tissue and supporting potent combination regimens. With such advances, we are poised to make real headway against molecularly well-defined cancers in the coming years – even those considered as hard targets due to immunological “coldness”, innate chemoresistance, or disease rarity.
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Novel Non-Animal Methodologies Secured Their Place in Preclinical Research
Beyond reshaping what reaches the market, 2025 also transformed how oncology drugs are tested before they reach the clinic. Late in the year, both the United States and the United Kingdom advanced major initiatives to encourage novel alternative methodologies (NAMs) and to refine, reduce, or replace traditional animal studies.
The FDA Modernization Act 3.0 is poised to reinforce that animal tests are no longer mandatory for first-in-human applications [9]. The agency has signalled that these gaps will be filled by a range of approaches, including AI-driven toxicity prediction, advanced in vitro assays, and organoid systems. Across the Atlantic, the UK government launched the £75 million “Replacing Animals in Science” initiative, aimed at accelerating animal replacement while delivering equal or better predictive power [10].
Of course, cancer research is moving quickly to match these ambitions. In October 2025, the FDA permitted the first Investigational New Drug application based solely on organoid efficacy data [11]. This set a new precedent in preclinical testing and was a tangible step towards regulatory and ethical goals. However, despite the enthusiasm for these micro-physiological models, the biological complexity of cancer should always be remembered. Tumour–host interactions, systemic immune effects, and long-term off-target risks can still escape current in vitro models, no matter how sophisticated. Many regulators and scientists therefore stress that NAMs will complement, not completely replace, studies in intact organisms until robust validation frameworks are in place.
The NAM ecosystem remains young and fragmented, and standards for their validation, review and use must be set. Over the next few years, oncology developers can expect a hybrid testing landscape; with next-generation in silico and in vitro models used alongside streamlined animal studies to build the evidence base these new tools require – while continually refining the ethical use of living subjects in preclinical research.
AI’s Impact Deepens: Discovery, Trial Analysis, and Real-Time Review
In recent years, artificial intelligence has moved from the periphery of drug development to being a major driving force and routine tool for the industry. In the broader landscape of pharmacology, Insilico Medicine’s Rentosertib – the first fully AI-discovered drug – completed Phase IIa clinical trials for idiopathic pulmonary fibrosis in early 2025, in a landmark moment for generative AI-powered drug discovery. The same year, Insilico began first-in-patient dosing for two distinct anticancer molecules, underscoring that AI-designed drugs are now entering the clinic even in diseases as complex as cancer [12, 13].
AI is equally valuable once a therapy reaches the clinic. In Merck and Moderna’s melanoma programme combining Keytruda with an mRNA neoantigen vaccine, machine learning was used to analyse patient data and personalise the vaccine accordingly. AI-powered retroactive analysis has also reshaped the interpretation of existing data: after initial results from the 2024 TROPION-Lung01 trial suggested limited benefit for Dato-DXd, the use of a computational biomarker found subgroups with clinically meaningful survival advantages. This insight supported a refined, successful FDA approval package for certain lung cancer use cases in 2025 [14].
The use of AI in oncology will only expand, but reaching full potential relies on large, quality datasets and transparent, bias-aware validation. Addressing these challenges is essential to translate algorithms into reliable clinical gains. Nonetheless, in a world of oncology that is becoming more mechanistic, data-led and precise and further from the realm of large-scale animal testing, it goes without saying that AI will be a key part of the development pipeline.
Embracing the future of oncology
Oncology in 2026 will be defined by innovation, precision, and adaptability. Excitingly, this period of scientific advancement is also converging with a more agile regulatory environment. Programmes such as the FDA’s Real-Time Oncology Review, Project Orbis and EMA initiatives like PRIME will shorten development timelines and reward sponsors with robust data packages and validated analytics.
This period of evolution demands that next-gen approaches like NAMs and AI-directed designs are paired with thoroughly validated and established models, and that strong foundations are laid for the integration and standardisation of new methods. Quality control will be critical to balance speed and rigour, and close collaboration with expert service providers who are aware of these intricacies could be a massive success factor for pharmaceutical developers.
References
- Novel Drug Approvals for 2025. U.S. Food and Drug Administration. 2025.
- FDA approves epcoritamab-bysp for follicular lymphoma indications. U.S. Food and Drug Administration. 2025.
- Moderna & Merck Announce 5-Year Data for Intismeran Autogene in Combination With KEYTRUDA® (pembrolizumab) Demonstrated Sustained Improvement in the Primary Endpoint of Recurrence-Free Survival in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection – Merck. 2026.
- FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenal. U.S. Food and Drug Administration. 2026.
- Datroway (datopotamab deruxtecan) approved in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer. AstraZeneca. 2025.
- FDA grants accelerated approval to telisotuzumab vedotin-tllv for NSCL. U.S. Food and Drug Administration. 2025.
- FDA grants traditional approval to tarlatamab-dlle for extensive stage small cell lung cancer. U.S. Food and Drug Administration. 2025.
- Bristol Myers Squibb’s Breyanzi Approved by the U.S. FDA as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Marginal Zone Lymphoma (MZL) BMS. 2025.
- Cory B. S.355 – 119th Congress (2025-2026): FDA Modernization Act 3.0. Congress. 2025.
- Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods. GOV.UK. 2025.
- Qureator’s Historic FDA IND Approval Based on Human-Relevant Data Highlighted in The BIO – Qureator, Inc. 2025.
- Thomas M. First patient receives novel MAT2A inhibitor for solid tumours. Drug Discovery World (DDW). 2025.
- Wright L. First ISM6331 Dose Given to Mesothelioma Patient in Clinical Trial. 2025.
- FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer. U.S. Food and Drug Administration. 2025.
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