Second fast-track designation for Australian immunotherapy company

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Australian immunotherapy company Immutep (ASX:IMM) has secured fast-track designation from the US FDA for its eftilagimod alpha (efti) for use in combination with MSD's KEYTRUDA (pembrolizumab) for the first line treatment of non-small cell lung cancer (NSCLC).

Efti is Immutep's first-in-class soluble LAG-3 clinical stage candidate.

It is the second fast-track designation the FDA has granted efti. It has previously been granted the designation for use in combination with KEYTRUDA for the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

“We are pleased to receive this Fast Track designation as it acknowledges efti’s unique potential to empower the human immune system against cancer and significantly enhance patient responses to standard-of-care immunotherapy. Efti also offers a chemotherapy-free option for NSCLC patients in need of less toxic and more durable solutions,” said CEO Marc Voigt.

“This important designation that efti has now received across two indications, 1st line NSCLC and 1st 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. We look forward to providing additional clinical data in 1st line NSCLC later this year,” he concluded.

The FDA’s fast-track designation process facilitates the development and expedites the review of drug candidates to treat serious conditions that fill unmet medical needs.