VELARION aumolertinib 55 mg film coated tablet bottle Glenmark Pharmaceuticals Australia Pty Ltd
Product name
VELARION aumolertinib 55 mg film coated tablet bottle
Accepted date
Jun-2026
Active ingredients
aumolertinib
Summary of proposed indication
VELARION (aumolertinib) works by blocking a protein called epidermal growth factor receptor (EGFR).
VELARION is proposed:
•for use on its own to treat adults with non-small cell lung cancer (NSCLC).
•as the initial treatment for adults with NSCLC that has spread to nearby tissues or to other parts of the body and has activating changes, called mutations, in the EGFR gene. These mutations send ongoing signals that tell the cancer cells to grow and multiply.
•to treat adults with NSCLC that has spread to nearby tissues or to other parts of the body and has a specific EGFR mutation called T790M. This mutation can stop some EGFR-targeted cancer treatments from working.
VELARION is proposed:
•for use on its own to treat adults with non-small cell lung cancer (NSCLC).
•as the initial treatment for adults with NSCLC that has spread to nearby tissues or to other parts of the body and has activating changes, called mutations, in the EGFR gene. These mutations send ongoing signals that tell the cancer cells to grow and multiply.
•to treat adults with NSCLC that has spread to nearby tissues or to other parts of the body and has a specific EGFR mutation called T790M. This mutation can stop some EGFR-targeted cancer treatments from working.
Application type
A (new medicine)
Publication date
Jun-2026