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FDA Grants Fast Track Designation to Infigratinib for First-Line Treatment of Cholangiocarcinoma

Nichole Tucker
Published Online:5:10 PM, Mon January 6, 2020
Infigratinib (BGJ398) has been granted Fast Track Designation by the FDA for the treatment of cholangiocarcinoma in adult patients with first-line advanced or metastatic disease, according to a press release from QED Therapeutics, a subsidiary of BridgeBio Pharma, Inc, and developer of infigratinib.

“We believe that Fast Track and Orphan Drug Designations for infigratinib for the treatment of cholangiocarcinoma underscores the need for new, targeted treatments for genetically-driven subsets of this cancer, particularly for adults with first-line advanced or metastatic cholangiocarcinoma,” said Susan Moran, MD, MSCE, chief medical officer for QED Therapeutics. “Fast Track Designation will enhance our interaction with the FDA on our first-line advanced or metastatic cholangiocarcinoma program and may help us get this medicine to patients more quickly.”

Infigratinib is currently under investigation in the phase III PROOF trial, which has begun dosing patients with advanced cholangiocarcinoma with FGFR2 gene fusions or translocations. PROOF is a multicenter, open-label, randomized, controlled phase III study of infigratinib versus gemcitabine with cisplatin.

The study plans to enroll 384 patients the first-line cholangiocarcinoma with FGFR2 fusions or translocations, as determined by molecular profiling and randomize them 2:1 to either imfigratinib 125 mg orally daily, 3 weeks on, 1 week off or the standard-of-care chemotherapy, which is gemcitabine 1000 mg/m2 intravenously on day 1 and day 8 for a 21-day cycle and cisplatin 25 mg/m2 intravenously on day 1 and day 8 for a 21-day cycle. The primary end point of the study is progression-free survival (PFS). The co-secondary end points are overall survival and the percentage of investigator-assessed PFS in patients treated with infigratinib versus gemcitabine/cisplatin.

“Importantly, in this trial, patients who are assigned to receive standard of care will be allowed to crossover and receive infigratinib if they do not respond to chemotherapy,” said Stacie Lindsey, president of the Cholangiocarcinoma Foundation. “Having a crossover option is very significant to patients and including it in the design of this trial demonstrates that QED is listening to them.”

Patients are eligible to enroll in the PROOF trial if they have a histologically or cytologically confirmed non-resectable, recurrent or metastatic cholangiocarcinoma, excluding those with gallbladder cancer or ampulla of Vater carcinoma. Patients must have documented FGFR-2 gene fusions or translocations, and an ECOG performance status of 0 or 1.

The study excludes patients who have had any systemic anti-cancer therapy for unresectable, recurrent, or metastatic cholangiocarcinoma. Prior neoadjuvant or adjuvant therapy is permitted if completed >6 months prior to the first dose of study drug. Patients are also excluded if they have a history of a liver transplant, another primary malignancy within 3 years, or history or current evidence of tissue calcification. Other exclusion criteria included those who had prior or current treatment with a mitogen-activated protein kinase or selective FGFR inhibitor and patients with certain conditions that may interfere with treatment with infigratinib or chemotherapy.

As a result of the Fast Track Designation, infigratinib will have 7 years of market exclusivity, when the drug is approved. Also, the drug may receive tax credits for clinical research costs, and study design assistance,  the ability to apply for annual grant funding, and waived Prescription Drug User Fee Act filing fees.
BridgeBio Pharma’s QED Therapeutics Receives Fast Track Designation for Infigratinib in Adults with First-Line Advanced or Metastatic Cholangiocarcinoma and Orphan Drug Designation for Infigratinib for Treatment of Cholangiocarcinoma [news release]. San Francisco, California: BridgeBio Pharma Inc; January 6, 2020. https://bit.ly/2sI7AId. Accessed January 6, 2020.

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