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Disease

Squamous Cell Carcinoma of Head and Neck

Active therapeutic pipelineEmerging researchCooling momentum
21
Publications
2
Clinical trials
7
Related conditions
1
Related treatments
6
Related proteins
2025
Latest publication
Current focus
Antibodies biologyQ9nzq7 biologyTherapeutic developmentInflammation & immunity
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

The dynamic role of immune checkpoint molecules in diagnosis, prognosis, and treatment of head and neck cancers.

Research2024-01-06Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie

Oral squamous cell carcinomas: state of the field and emerging directions.

Research2023-09-22International journal of oral science

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Low
Key developments
  • 1 clinical trial with recent milestones (1 completed or reporting results).

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies

Approval — Melanoma Keytruda as monotherapy is indicated for the treatment of adults and adolescents… (2015)

Docetaxelapproved

Approval — Breast cancer Docetaxel Kabi in combination with doxorubicin and cyclophosphamide is indi… (2012)

Temoporfinapproved

Approval — Foscan is indicated for the palliative treatment of patients with advanced head and neck… (2001)

Research-associated treatments

Clinical trials

2 sponsors · 0 new · 1 completed in the last 12 months (net +0)

The current development programme across all trial phases.

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2015emaApprovalPembrolizumab· Melanoma Keytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. Keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC, or with Stage III melanoma and lymph node involvement who have undergone complete resection. Non small cell lung carcinoma (NSCLC) Keytruda, in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non small cell lung carcinoma at high risk of recurrence in adults Keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5.1). Keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express PD L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations. Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no EGFR or ALK positive mutations. Keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. Keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express PD L1 with a ≥ 1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA. Malignant pleural mesothelioma (MPM) Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first‑line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma. Classical Hodgkin lymphoma (cHL) Keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option. Urothelial carcinoma Keytruda, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin‑containing chemotherapy. Keytruda, in combination with enfortumab vedotin, is indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults. Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy.Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express PD L1 with a combined positive score (CPS) ≥ 10. Head and neck squamous cell carcinoma (HNSCC) Keytruda as monotherapy is indicated for the treatment of resectable locally advanced head and neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumours express PD-L1 with a CPS ≥ 1. Keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 FU) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD L1 with a CPS ≥ 1. Keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD L1 with a ? 50% TPS and progressing on or after platinum containing chemotherapy. Renal cell carcinoma (RCC) Keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. Keytruda, in combination with lenvatinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. Keytruda as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5.1). Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers Colorectal cancer (CRC)Keytruda as monotherapy is indicated for theadults with MSI-H or dMMR colorectal cancer in the following settings: first line treatment of metastatic microsatellite instability high (MSI H) or mismatch repair deficient (dMMR) colorectal cancer in adults; treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  Non-colorectal cancersKeytruda as monotherapy is indicated for the treatment of the following MSI H or dMMR tumours in adults with: advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation; unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. Oesophageal carcinoma Keytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus in adults whose tumours express PD L1 with a CPS ≥ 10. Triple negative breast cancer (TNBC) Keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. Keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express PD L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease. Endometrial carcinoma (EC) Keytruda, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy.  Keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. Cervical cancer Keytruda, in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy), is indicated for the treatment of FIGO 2014 Stage III - IVA locally advanced cervical cancer in adults who have not received prior definitive therapy.  Keytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD L1 with a CPS ≥ 1. Gastric or gastro-oesophageal junction (GEJ) adenocarcinoma Keytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1. Keytruda, in combination with fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD L1 with a CPS ≥ 1 (see section 5.1). Biliary tract carcinoma (BTC) Keytruda, in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults. Ovarian Cancer Keytruda, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of platinum‑resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PD‑L1 with a CPS ≥ 1 and who have received one or two prior systemic treatment regimens. source ↗
2012emaApprovalDocetaxel· Breast cancer Docetaxel Kabi in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Kabi in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Kabi monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Kabi in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Kabi in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Kabi is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Kabi in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Kabi in combination with prednisone or prednisolone is indicated for the treatment of patients with castration-resistant metastatic prostate cancer. Docetaxel Kabi in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer. Gastric adenocarcinoma Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck. source ↗
2012emaApprovalDocetaxel· Breast cancer Docetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Accord in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Accord in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Accord is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Accord in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Accord in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck. source ↗
2001emaApprovalTemoporfin· Foscan is indicated for the palliative treatment of patients with advanced head and neck squamous cell carcinoma failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy. source ↗
1995emaApprovalDocetaxel· Breast cancer Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Taxotere in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Taxotere monotherapy is indicated for the treatment of patients with locally advanced ormetastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Taxotere in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Taxotere in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Taxotere is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Taxotere in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Taxotere in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Research activity

21 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Publications over time
20172025
Most influential
Recent publications
Major themes8
  • Head and Neck Neoplasms12
  • Carcinoma, Squamous Cell5
  • Squamous Cell Carcinoma of Head and Neck4
  • Mouth Neoplasms3
  • Immunotherapy2
  • Tumor Microenvironment2
  • Antibodies, Monoclonal, Humanized1
  • Antineoplastic Agents1
Leading journals6
  • International journal of oral science3
  • Nature communications3
  • Advances in anatomic pathology1
  • Annals of oncology : official journal of the European Society for Medical Oncology1
  • Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie1
  • Cancer cell1
Leading researchers8
  • Ferris RL4
  • Uppaluri R3
  • Bruno TC2
  • Burtness B2
  • Cillo AR2
  • Duvvuri U2
  • Elbers JBW2
  • Haanen JBAG2
Affiliations (unnormalised)6
  • UPMC Hillman Cancer Center4
  • Brigham and Women's Hospital2
  • Leiden University Medical Center2
  • Memorial Sloan Kettering Cancer Center2
  • Oncode Institute2
  • School of Medicine2

Disease biology

6 matches

Key proteins & gene products studied in this disease. Number shows shared papers.

Related conditions

7 matches

Diseases frequently studied alongside this one. Number shows shared papers.

Disease profile

A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.

Overview

Head and neck squamous cell carcinoma is the most common carcinoma of the head and neck region and arises from the surface epithelium of sites such as the nasal cavity, mouth, paranasal sinuses, salivary glands, and larynx. It is a heterogeneous group of aggressive cancers that are often diagnosed at a late stage. The literature commonly distinguishes HPV-positive from HPV-negative disease.

Causes

Known associated causes include tobacco consumption and alcohol abuse, particularly for oral cavity and laryngeal cancers. Pharyngeal cancers are increasingly attributed to infection with human papillomavirus, especially HPV-16. The disease is also associated with mutations in TNFRSF10B, PTEN, and ING1.

Pathophysiology

The disease develops through histological progression from cellular atypia and dysplasia to invasive squamous carcinoma, although many cases present without an obvious premalignant lesion. Its biology is shaped by genetic alteration, epigenetic modification, and a dysregulated tumor microenvironment. Immune evasion and altered immune checkpoint signaling are important features, and the tumor microenvironment can promote angiogenesis, proliferation, and metastasis.

Risk factors

Persistent exposure to tobacco, alcohol, and betel quid increases risk, and HPV infection is an important risk factor for a subset of cases. Oral potentially malignant disorders are also described as lesions with increased risk of progression to oral squamous cell carcinoma. The literature further supports a role for a dysregulated tumor microenvironment in disease development and progression.

Current standard of care

For most patients, surgery and radiotherapy are the primary treatment modalities. Conventional cytotoxic chemotherapy is also used, and regional surgery, irradiation, and chemotherapy are described as the main options outside of targeted approaches. Immunotherapy with immune checkpoint inhibitors, including PD-1/PD-L1- and CTLA-4-directed agents, is an active treatment class in the literature, but the supplied grounding does not support a broader standard-of-care statement beyond these modalities.

AI-generated summary grounded in MeSH and 6 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-07.

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

The most common type of head and neck carcinoma that originates from cells on the surface of the NASAL CAVITY; MOUTH; PARANASAL SINUSES, SALIVARY GLANDS, and LARYNX. Mutations in TNFRSF10B, PTEN, and ING1 genes are associated with this cancer.

References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.