Last updated: November 15, 2026
The treatment landscape for solid tumours continues to evolve as advances in precision oncology, immunotherapy, molecular diagnostics and targeted medicines create new therapeutic possibilities. Recent regulatory approvals and clinical guideline developments are expanding treatment options across several cancer types, including breast cancer, colorectal cancer, lung cancer, prostate cancer, bladder cancer and other advanced malignancies.
In 2026, several important developments have emerged, including new indications for immunotherapies, biomarker-directed treatments, antibody-based medicines and combination treatment strategies.
These developments reflect a broader shift in oncology: treatment decisions are increasingly influenced by tumour biology, genetic alterations, biomarker expression and previous treatment response rather than cancer location alone.
This article reviews important solid-tumour treatment developments in 2026, selected FDA approvals, emerging clinical guidance and the role of specialty medicines in modern cancer care.
What Are Solid Tumours?
Solid tumours are abnormal masses of tissue that develop in organs or other body structures. They can be benign or malignant, although the term is commonly used in oncology to describe cancers originating in organs and tissues.
Unlike blood cancers such as leukaemia, solid tumours generally develop within specific anatomical locations.
Common types include:
- Breast cancer
- Lung cancer
- Colorectal cancer
- Prostate cancer
- Liver cancer
- Pancreatic cancer
- Kidney cancer
- Ovarian cancer
- Bladder cancer
- Gastric cancer
- Head and neck cancers
Solid tumours may be classified according to their origin, histological characteristics, disease stage and molecular profile.
Modern oncology increasingly uses molecular diagnostics to identify specific genetic alterations and biomarkers that may help determine whether a patient is eligible for targeted treatment.
Major Developments in Solid Tumour Therapeutics in 2026
Recent developments in oncology have focused on expanding treatment indications, improving patient selection and introducing new treatment combinations.
Some important therapeutic developments include:
1. Immunotherapy and Checkpoint Inhibitors
Immune checkpoint inhibitors have become important treatment options across several solid tumour types.
These medicines work by targeting immune regulatory pathways that cancer cells can exploit to avoid immune detection.
Important checkpoint inhibitor targets include:
- PD-1 (programmed cell death protein 1)
- PD-L1 (programmed death-ligand 1)
- CTLA-4 (cytotoxic T-lymphocyte-associated protein 4)
Examples include pembrolizumab, nivolumab, atezolizumab and durvalumab.
An important 2026 development was the FDA’s traditional approval of pembrolizumab for adults and paediatric patients with unresectable or metastatic tumour mutational burden-high (TMB-H) solid tumours.
The updated indication specifies a TMB threshold of at least 13 mutations per megabase (mut/Mb), determined using an FDA-authorised test. Eligible patients must have disease progression following prior treatment and no satisfactory alternative treatment options.
This update is particularly important because it demonstrates how biomarker thresholds can influence treatment eligibility.
2. Targeted Cancer Therapies
Targeted therapies are medicines designed to interfere with specific molecular pathways involved in cancer growth and survival.
Unlike conventional chemotherapy, which can affect both cancerous and healthy rapidly dividing cells, targeted medicines act on particular molecular targets.
Important therapeutic categories include:
- Tyrosine kinase inhibitors (TKIs)
- PARP inhibitors
- CDK4/6 inhibitors
- EGFR inhibitors
- HER2-targeted therapies
- FGFR inhibitors
- ROS1 inhibitors
- RET inhibitors
- BRAF inhibitors
- VEGF inhibitors
Examples include osimertinib, abemaciclib, olaparib, alectinib, selpercatinib and tepotinib.
The selection of these treatments depends on cancer type, molecular findings, approved indications and clinical circumstances.
3. Antibody-Drug Conjugates
Antibody-drug conjugates (ADCs) combine a monoclonal antibody with a cytotoxic drug through a specialised chemical linker.
The antibody recognises a particular target expressed by cancer cells, allowing the attached drug to be delivered more selectively.
Important examples include:
- Trastuzumab deruxtecan
- Sacituzumab govitecan
- Enfortumab vedotin
- Trastuzumab emtansine
ADCs represent an important area of oncology research and treatment development, particularly in breast cancer, bladder cancer and other solid tumours.
Important FDA Solid Tumour Drug Approvals and Expanded Indications in 2026
Several regulatory decisions in 2026 have expanded the treatment options available for patients with different solid tumour types.
The following are selected developments reported by the US Food and Drug Administration.
1. Pembrolizumab for TMB-H Solid Tumours
Approval date: October 16, 2026
The FDA granted traditional approval to pembrolizumab (Keytruda), including pembrolizumab with berahyaluronidase alfa-pmph (Keytruda Qlex), for eligible adult and paediatric patients with unresectable or metastatic TMB-H solid tumours.
The updated indication requires:
- Tumour mutational burden of at least 13 mut/Mb.
- Testing using an FDA-authorised test.
- Disease progression following prior treatment.
- No satisfactory alternative treatment options.
This approval converts the earlier accelerated approval into traditional approval while revising the biomarker threshold.
Clinical significance: This development reinforces the importance of molecular profiling in identifying patients who may qualify for tumour-agnostic immunotherapy.
2. Dostarlimab for Locally Advanced Rectal Cancer
Approval date: October 19, 2026
The FDA granted accelerated approval to dostarlimab (Jemperli) for adults with Stage II or Stage III locally advanced rectal cancer that is:
- Microsatellite instability-high (MSI-H), or
- Mismatch repair deficient (dMMR).
These molecular characteristics are important because they can influence tumour response to immunotherapy.
Clinical significance: The approval expands biomarker-directed immunotherapy options for a defined group of patients with locally advanced rectal cancer.
3. Atezolizumab for Stage III dMMR Colon Cancer
Approval date: October 8, 2026
The FDA approved atezolizumab (Tecentriq) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of eligible patients with Stage III mismatch repair-deficient colon cancer.
The approval also included atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for specified patient populations.
Clinical significance: This development introduces an immunotherapy-based combination into the adjuvant treatment setting for a biomarker-defined colon cancer population.
4. Nogapendekin Alfa Inbakicept for Bladder Cancer
Approval date: October 14, 2026
The FDA expanded the indication for nogapendekin alfa inbakicept-pmln (Anktiva), in combination with Bacillus Calmette-Guérin (BCG), for adults with BCG-unresponsive non-muscle-invasive bladder cancer.
The updated indication includes patients with high-grade papillary-only tumours.
Clinical significance: The expanded indication provides another treatment option for a specific population with BCG-unresponsive bladder cancer.
5. Talazoparib Plus Enzalutamide for Prostate Cancer
Approval date: October 26, 2026
The FDA approved talazoparib (Talzenna) in combination with enzalutamide for adults with metastatic androgen pathway modulation-naïve or androgen pathway modulation-sensitive prostate cancer carrying homologous recombination repair (HRR) gene mutations.
An FDA-authorised test is required to identify eligible patients.
Talazoparib is a PARP inhibitor, while enzalutamide acts as an androgen receptor inhibitor.
Clinical significance: This combination demonstrates the increasing role of molecularly selected treatment strategies in advanced prostate cancer.
6. Additional Developments in November 2026
Subsequent FDA decisions have further expanded the oncology treatment landscape.
Amivantamab and hyaluronidase-lpuj
On November 5, 2026, the FDA granted accelerated approval to this formulation for eligible adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed on or after platinum-based chemotherapy and anti-PD-(L)1 therapy. HPV-associated oropharyngeal squamous cell carcinoma is excluded from this indication.
Durvalumab and enfortumab vedotin
On November 13, 2026, the FDA approved durvalumab with enfortumab vedotin-ejfv as neoadjuvant treatment, followed by adjuvant durvalumab, for specified adults with muscle-invasive bladder cancer who are ineligible for or have refused cisplatin-based chemotherapy.
These decisions illustrate how oncology approvals continue to evolve beyond traditional chemotherapy-based treatment approaches.
Important Biomarkers in Modern Solid Tumour Treatment
Biomarker testing plays an increasingly important role in identifying patients who may benefit from specific cancer medicines.
Some important biomarkers include:
| Biomarker | Clinical relevance |
|---|---|
| EGFR | Helps identify candidates for EGFR-targeted treatment in selected cancers |
| HER2 | Important in breast, gastric and other HER2-positive cancers |
| ALK | Relevant to selected targeted treatments in lung cancer |
| ROS1 | Identifies a molecular subgroup of non-small cell lung cancer |
| BRAF | Relevant to targeted treatment strategies in selected tumours |
| BRCA1/BRCA2 | Important in homologous recombination repair and PARP inhibitor selection |
| MSI-H/dMMR | May identify patients eligible for certain immunotherapies |
| TMB-H | May identify patients eligible for specific tumour-agnostic immunotherapy indications |
| RET | Relevant to RET-targeted therapies |
| FGFR2 | Important in selected biliary tract cancers |
| ESR1 | Relevant to selected hormone receptor-positive breast cancers |
| PD-L1 | Helps guide treatment selection in certain cancer types |
Biomarker results must always be interpreted alongside the tumour type, disease setting, approved drug indication and current clinical guidance.
Clinical Guideline Developments in 2026
Regulatory approvals are only one part of oncology treatment development. Clinical guidelines also help healthcare professionals interpret emerging evidence and incorporate appropriate treatment approaches into clinical practice.
The National Comprehensive Cancer Network (NCCN) and American Society of Clinical Oncology (ASCO) are important sources of evidence-based oncology guidance.
1. Greater Emphasis on Molecular Profiling
Molecular profiling is becoming increasingly important in treatment planning.
For selected cancer types, testing may identify:
- Actionable gene mutations
- Gene fusions
- Protein expression
- DNA repair deficiencies
- Microsatellite instability
- Tumour mutational burden
This information can help clinicians evaluate targeted medicines, immunotherapy and clinical trial eligibility.
2. Circulating Tumour DNA Testing
Circulating tumour DNA (ctDNA) refers to fragments of tumour-derived DNA that can be detected in blood samples.
ASCO published its first guideline addressing ctDNA testing in solid tumours and lymphoma in June 2026.
The guidance supports the use of ctDNA testing in selected situations, including when tissue testing is difficult, unsafe or unlikely to produce results within a clinically useful timeframe.
However, a negative or inconclusive ctDNA result may require confirmation using tissue-based testing when clinically appropriate.
The guideline also emphasises that ctDNA should be used when its results can inform evidence-based clinical decisions rather than being treated as a universal replacement for conventional diagnostic methods.
3. More Personalised Treatment Selection
The 2026 oncology guideline updates increasingly reflect the importance of tumour biology and patient-specific characteristics.
For example, updated recommendations across kidney, colorectal, breast and other cancers have addressed biomarker testing, immunotherapy combinations and treatment sequencing.
The practical implication is that a treatment considered appropriate for one molecular subgroup may not be appropriate for another patient with the same anatomical cancer diagnosis.
Healthcare professionals should consult the latest disease-specific guideline version before making treatment decisions.
The Role of Specialty Medicines in Solid Tumour Treatment
Specialty medicines are an important part of modern cancer treatment.
Many oncology medicines require specialised handling, monitoring, prescription management and coordination between healthcare professionals.
Examples of specialty oncology medicine categories include:
1. Targeted therapy medicines
- EGFR inhibitors
- ALK inhibitors
- PARP inhibitors
- CDK4/6 inhibitors
- RET inhibitors
2. Immunotherapy medicines
- PD-1 inhibitors
- PD-L1 inhibitors
- CTLA-4 inhibitors
3. Hormonal and endocrine therapies
- Aromatase inhibitors
- Selective oestrogen receptor degraders
- Androgen receptor inhibitors
4. Other advanced oncology treatments
- Antibody-drug conjugates
- Angiogenesis inhibitors
- Selected molecularly targeted agents
Access to these medicines can involve complex sourcing, prescription verification, storage requirements and regulatory considerations.
A specialised pharmacy network can help coordinate medicine access and provide reliable product information while working within applicable pharmaceutical regulations.
What These Developments Mean for Patients and Healthcare Professionals
The latest developments in solid tumour therapeutics highlight several important considerations.
For patients and caregivers:
- Ask the treating oncologist whether biomarker testing is appropriate.
- Understand the approved indication of any prescribed medicine.
- Discuss potential benefits, risks and adverse effects with the healthcare team.
- Confirm medicine availability and regulatory requirements before arranging treatment.
- Do not change or discontinue prescribed cancer treatment without medical advice.
For pharmacists and healthcare professionals:
- Keep up with new regulatory approvals and updated prescribing information.
- Verify biomarker-specific eligibility requirements.
- Review drug interactions, contraindications and safety monitoring requirements.
- Support medication adherence and continuity of care.
- Follow current professional guidelines and local regulatory requirements.
The Future of Solid Tumour Therapeutics
The future of solid tumour treatment is increasingly connected to precision medicine, advanced diagnostics and molecularly targeted treatment strategies.
Several areas are expected to remain important:
- Personalised oncology: Treatment selection based on individual tumour characteristics.
- Combination therapies: Combining targeted medicines, immunotherapies and conventional treatments where evidence supports their use.
- Molecular diagnostics: Greater use of genomic profiling and selected liquid biopsy applications.
- Antibody-drug conjugates: Continued development of targeted drug-delivery technologies.
- Treatment monitoring: Better integration of clinical assessment, imaging and molecular testing.
- Improved medicine access: More coordinated specialty pharmacy and patient-support services.
However, emerging research findings do not automatically establish a new standard of care. Regulatory approval, clinical evidence and professional guidelines must be evaluated separately.
Conclusion
The 2026 solid tumour treatment landscape demonstrates the growing importance of precision oncology, immunotherapy, targeted medicines and biomarker-guided treatment selection.
New FDA approvals involving pembrolizumab, dostarlimab, atezolizumab, talazoparib and other oncology medicines have expanded treatment options for selected patient populations.
At the same time, developments in molecular profiling and ctDNA testing are influencing how clinicians evaluate cancer biology and treatment eligibility.
As a licensed pharmacy and global specialty medicines network, Drmeds.org recognises the importance of reliable specialty medicine information and access to complex treatments.
Our goal is to help patients and healthcare professionals navigate the specialty medicines landscape through accessible medicine information and responsible pharmaceutical services.
Medical disclaimer: This article is intended for educational purposes only. It does not replace professional medical advice, diagnosis or treatment. Cancer treatment decisions must be made by qualified healthcare professionals based on individual patient circumstances, current clinical guidelines and applicable regulatory approvals.
References and Further Reading
- US Food and Drug Administration – Oncology and Hematologic Malignancies Approval Notifications
- FDA – Pembrolizumab Approval for TMB-H Solid Tumours
- American Society of Clinical Oncology – ctDNA Testing Guideline
- The ASCO Post – 2026 NCCN Guideline Updates
- AACR – Cancer Policy Monitor, November 2026
Regulatory approvals and clinical guidelines can change. Readers should consult the latest official prescribing information and professional guidance.
