Amplia Therapeutics’ Narmafotinib Gets Fast-track Designation from FDA

The US Food and Drug Administration (FDA) has granted fast-track designation to narmafotinib, Amplia Therapeutics’ (ASX:ATX,OTC Pink:INNMF) lead drug for the treatment of advanced pancreatic cancer.

In a press release shared last Friday (September 20), the company explained that this designation will provide it with access to more frequent meetings and written communication with the FDA.

In the future, narmafotinib may also be able to receive accelerated approval and priority review from the FDA.

“With this designation, we can work more closely with the FDA to accelerate our clinical program and gather the most compelling evidence for regulatory approval in this devastating disease,” said Dr. Chris Burns, Amplia's CEO and managing director, also calling the news a signifiant milestone for the company.

Fast-track designation is granted to drugs that have the potential to offer an advantage over existing therapies for serious conditions. It helps speed development so patients in need can access them more quickly.

Narmafotinib is Amplia’s lead drug candidate. It is a highly selective and potent FAK inhibitor that has shown encouraging results in preclinical studies for the treatment of pancreatic and ovarian cancers.

Currently an ACCENT trial of narmafotinib is underway in Australia and South Korea. In the open-label Phase 2a trial, it is combined with chemotherapies gemcitabine and Abraxane to assess for safety, tolerability and efficacy.

Amplia was also cleared by the FDA for a trial of narmafotinib in pancreatic cancer in the US early this year, with the trial now in advanced planning stages. The FDA previously granted orphan drug designation to narmafotinib for pancreatic cancer, which Amplia said points to its promise in the treatment, prevention or diagnosis of rare diseases.

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Securities Disclosure: I, Gabrielle de la Cruz, hold no direct investment interest in any company mentioned in this article.