ROS1 in non-small cell lung cancer

5 EU-approved indications in non-small cell lung cancer need a ROS1 result: entrectinib (advanced), sugemalimab (1st line, metastatic), serplulimab (1st line, advanced), crizotinib (advanced) and repotrectinib (advanced).

Histology

Line of therapy

Approved indications, Non-small cell lung cancer
DrugBiomarker requirementRegimenSettingConditions
ROS1 fusion3
Crizotinib
Xalkori
Monotherapy
Any line
advanced
None
Entrectinib
Rozlytrekconditional
Monotherapy
Any line
advanced
No prior ROS1 inhibitor
Repotrectinib
Augtyroconditional
Monotherapy
Any line
advanced
None
EGFR/ALK/ROS1 negative1
Serplulimab
Hetronifly
+ carboplatin and pemetrexed
1L
advanced
Non-squamous only; Not candidates for surgery or radiotherapy (if locally advanced)
EGFR/ALK/ROS1/RET negative1
No sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations
+ platinum-based chemotherapy
1L
metastatic
None

16 approvals for NSCLC need no biomarker and apply whatever the result. All approvals for NSCLC

See also

Label wording5

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

  1. Entrectinib (Rozlytrek)
    Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.
  2. Sugemalimab (Cejemly)
    Cejemly in combination with platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small-cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations.
  3. Serplulimab (Hetronifly)
    HETRONIFLY in combination with carboplatin and pemetrexed is indicated for the first-line treatment of adult non-squamous NSCLC patients with no EGFR, ALK or ROS1 positive mutations and who have:  locally advanced NSCLC who are not candidates for surgery or radiotherapy, or  metastatic NSCLC.
  4. Crizotinib (Xalkori)
    The treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC)
  5. Repotrectinib (Augtyro)
    AUGTYRO as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC).