The U.S. Food and Drug Administration recently granted Fast Track designation for Narmafotinib to combat advanced pancreatic cancer. Gilead Sciences, Inc., the company behind Narmafotinib’s development, will get expedited reviews from the FDA, a move aimed at accelerating the drug’s development and potential approval.
The Fast Track designation is a significant milestone in the lengthy drug approval process. Established by the FDA, the program is designed to facilitate the development and hasten the review of drugs intended to treat serious conditions and fill an unmet medical need.
Narmafotinib is an oral small molecule tyrosine kinase inhibitor of ERBB3 (HER3) aimed at disrupting the transmission of growth signals in cancer cells. HER3 is a protein that can promote the growth of cancer cells when it is overactive or expressed in excess. By targeting this protein, Narmafotinib has shown promise to thwart the progression of cancer.
The move by the FDA is a significant stride towards addressing the unmet requirement for more effective drugs against pancreatic cancer. The sinister nature of pancreatic cancer lies in its lack of symptoms in its early stages, often getting diagnosed only when it has already advanced to other parts of the body — a fact that contributes to its high fatality rate.
The road to FDA Fast Track designation began back in 2018 when Gilead Sciences, Inc. initiated the first Phase 1 trial of Narmafotinib. Early trials demonstrated that the drug was generally well-tolerated and showed evidence of antitumor activity, prompting the decision to explore its efficacy and safety further in Phase 2 trials.
Phase 2 of the ZENITH20 clinical study featured patients diagnosed with previously treated metastatic Pancreatic Ductal Adenocarcinoma (PDAC). The objective response rate – which refers to the percentage of patients whose cancer shrinks or disappears following treatment – was marked at a promising 14%. This positive outcome has encouraged further planning for Phase 3.
To put this into context, advanced pancreatic cancer has a five-year survival rate of only 9%, one of the lowest for any type of cancer. According to the Pancreatic Cancer Action Network, pancreatic cancer is projected to become the second leading cause of cancer-related death by 2030.
The Fast Track designation for Narmafotinib highlights the potential it holds in the fight against pancreatic cancer. It now prepares Gilead Sciences, Inc., to navigate the rigorous review process that awaits before potential market approval is reached. Offering hope to the many patients afflicted by this devastating disease, it marks an important step in the fight against pancreatic cancer.