- Immutep (IMM) receives US FDA Fast Track designation for its efti drug candidate as a treatment for non-small cell lung cancer (NSCLC)
- The designation — Immutep’s second for the drug — is specifically for efti when used in combination with cancer drug pembrolizumab
- It gives Immutep access to more frequent interactions with the FDA and offers the potential for expedited development and review of the treatment
- The designation is granted based on “encouraging” phase two clinical data for efti in first-line NSCLC announced by Immutep earlier this year
- Shares in Immutep are up 8.33 per cent and trading at 26 cents as of 12:41 pm AEDT
Immutep (IMM) has received US FDA Fast Track designation for its eftilagimod alpha (efti) drug candidate as a treatment for non-small cell lung cancer (NSCLC).
The designation is the company’s second for the treatment, with Immutep having received the same designation for the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
Fast Track designation gives Immutep access to more frequent interactions with the FDA to discuss efti’s development path.
Further, if the relevant criteria are met, the company will be eligible for rolling review, accelerated approval and priority review.
CEO Marc Voigt said the designation acknowledged efti’s unique potential to empower the human immune system against cancer and significantly enhance patient responses to standard-of-care immunotherapy.
“This important designation that efti has now received across two indications, first-line NSCLC and first-line HNSCC, enables us to work more closely with the FDA to bring this novel treatment option to cancer patients in the most timely and efficient manner possible,” Mr Voigt said.
“We look forward to providing additional clinical data in first-line NSCLC later this year.”
The company said the Fast Track designation was granted based on “encouraging” phase two clinical data for efti in first-line NSCLC announced by Immutep earlier this year.
Shares in Immutep were up 8.33 per cent and trading at 26 cents as of 12:41 pm AEDT.