Cervical cancer

The EU has approved 5 indications of 4 drugs in cervical cancer. 1 of them needs a biomarker result: PD-L1 (1). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

Line of therapy

Approved indications, Cervical cancer
DrugBiomarker requirementRegimenSettingConditions
PD-L11
CPS ≥ 1
+ chemotherapy with or without bevacizumab
Any line
advanced
None
No biomarker required4
None
+ chemoradiotherapy (external beam radiation therapy followed by brachytherapy)
1L
locally adv.
No prior definitive therapy; FIGO 2014 Stage III - IVA
Cemiplimab
Libtayo
None
Monotherapy
2L
advanced
After platinum-based chemotherapy
None
Monotherapy
2L
advanced
Disease progression on or after systemic therapy
None
+ paclitaxel and cisplatin or paclitaxel and topotecan
Any line
advanced
Paclitaxel and topotecan for patients who cannot receive platinum therapy

Tumour-agnostic approvals6

Approved for any solid tumour that carries the alteration, wherever the tumour started.

DrugBiomarker requirementRegimenSettingConditions
EpCAM1
Monotherapy
2L
Malignant ascites; not eligible for further systemic anticancer therapy
HER21
Trastuzumab deruxtecan
Enhertuconditional
HER2-positive (IHC 3+)
Monotherapy
2L
advanced
After prior treatment; No satisfactory treatment options
NTRK fusion3
Entrectinib
Rozlytrekconditional
Monotherapy
Any line
No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options
Larotrectinib
Vitrakviconditional
Monotherapy
Any line
Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options
Repotrectinib
Augtyroconditional
Monotherapy
Any line
advanced
Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older
RET fusion1
Monotherapy
Any line
advanced
Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older

Biomarkers in cervical cancer

Label wording5

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Pembrolizumab (Keytruda)
    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.
  2. Pembrolizumab (Keytruda)
    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.
  3. Bevacizumab (Avastin)
    Bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).
  4. Tisotumab vedotin (Tivdak)
    Tivdak as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy (see section 5.1).
  5. Cemiplimab (Libtayo)
    LIBTAYO as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.