Small cell lung cancer

The EU has approved 7 indications of 6 drugs in small cell lung cancer. None of them needs a biomarker result. 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

Line of therapy

Approved indications, Small cell lung cancer
DrugBiomarker requirementRegimenSettingConditions
No biomarker required7
Atezolizumab
Tecentriq
None
+ carboplatin and etoposide
1L
advanced
None
Durvalumab
Imfinzi
None
+ etoposide and either carboplatin or cisplatin
1L
advanced
None
Serplulimab
Hetronifly
None
+ carboplatin and etoposide
1L
advanced
None
Tislelizumab
Tevimbra
None
+ etoposide and platinum chemotherapy
1L
advanced
None
None
+ atezolizumab
Maint.
advanced
After first-line induction therapy with atezolizumab, carboplatin and etoposide without disease progression
Durvalumab
Imfinzi
None
Monotherapy
Consol.
locally adv.
After platinum-based chemoradiation therapy without progression
Tarlatamab
Imdylltra
None
Monotherapy
2L
advanced
Disease progression on or after first-line treatment with platinum-based chemotherapy; Who require systemic 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
Label wording7

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

  1. Durvalumab (Imfinzi)
    IMFINZI as monotherapy is indicated for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy.
  2. Durvalumab (Imfinzi)
    IMFINZI in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).
  3. Serplulimab (Hetronifly)
    HETRONIFLY in combination with carboplatin and etoposide is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
  4. Tislelizumab (Tevimbra)
    Tevimbra, in combination with etoposide and platinum chemotherapy, is indicated for the first-line treatment of adult patients with extensive-stage SCLC.
  5. Atezolizumab (Tecentriq)
    Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (see section 5.1).
  6. Tarlatamab (Imdylltra)
    IMDYLLTRA is indicated as monotherapy for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy.
  7. Lurbinectedin (Zepzelca)
    ZEPZELCA, in combination with atezolizumab, is indicated for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.