Reason for request

Re-assessment of actuel benefit and improvement in actual benefit

No clinical added value demonstrated in 1st and 2nd lines of locally advanced or metastatic non-squamous non-small cell lung cancer .

Minor improvement of clinical added value in maintenance therapy in patients whose the disease has not progressed after first-line treatment.

 

  • ALIMTA has Marketing Authorisation in the following indications:
  • In combination with cisplatin, in the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), in other than predominantly squamous cell histology,
  • In monotherapy for the maintenance treatment therapy of locally advanced or metastatic NSCLC other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy,
  • In monotherapy for the second-line treatment of patients with locally advanced or metastatic NSCLC other than predominantly squamous cell histology.
  • It is part of the first-line and second-line options in treatment of NSCLC. In maintenance therapy, ALIMTA is the standard treatment option, if this molecule is administered at the onset ("continued maintenance”) or in stable or responders patients after 4 to 6 cycles of a platinum-based doublet without pemetrexed ("switch maintenance").

Clinical Benefit

Substantial

-


Clinical Added Value

minor

-

no clinical added value

Therapeutic use

-

Contact Us

Évaluation des médicaments