FDA Drug Approval Decisions Expected in February 2024
The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA) and making a final decision on marketing approval. The typical period for review is 10 months after the drug application has been accepted by the Agency. For drugs that have Priority Review, the review period is reduced to 6 months from the time of application acceptance.
Irinotecan Liposome Injection (Onivyde®) Regimen for Pancreatic Ductal Adenocarcinoma
PDUFA date: February 13, 2024
The FDA is reviewing the supplemental NDA (sNDA) for irinotecan liposome injection (Onivyde) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) for the first-line treatment for metastatic pancreatic ductal adenocarcinoma. Irinotecan liposome injection is a topoisomerase 1 inhibitor encapsulated in a lipid bilayer vesicle or liposome.The sNDA is supported by data from the phase 3 NAPOLI 3 trial (ClinicalTrials.gov Identifier: NCT04083235). Results showed a statistically significant improvement in overall survival and progression free survival in patients treated with NALIRIFOX compared with those who received nab-paclitaxel and gemcitabine.
Cefepime-Taniborbactam for Complicated Urinary Tract Infections, Including Pyelonephritis
PDUFA date: February 22, 2024
Cefepime-taniborbactam is an investigational intravenous beta-lactam/beta-lactamase inhibitor antibiotic. The combination has demonstrated in vitro activity against clinically significant gram-negative bacteria, including carbapenem-resistant Enterobacterales, multidrug-resistant Pseudomonas aeruginosa and extended spectrum beta-lactamase-producing Enterobacterales. The NDA is supported by data from the phase 3 CERTAIN-1 study (ClinicalTrials.gov Identifier: NCT03840148), which compared the efficacy and safety of cefepime-taniborbactam to meropenem in 661 adults with cUTI, including acute pyelonephritis. Findings showed treatment with cefepime-taniborbactam was noninferior to meropenem at the test of cure visit.
Lifileucel for the Treatment of Advanced Melanoma
PDUFA date: February 24, 2024
Lifileucel is a one-time autologous adoptive cell transfer therapy that utilizes a tumor infiltrating lymphocyte manufacturing process. The BLA is supported by data from the C-144-01 study (ClinicalTrials.gov Identifier: NCT02360579), which evaluated lifileucel in adults with advanced melanoma. The efficacy analysis included 153 patients, all of whom had progressed on or after immune checkpoint inhibitor therapy and targeted BRAF/MEK inhibitor therapy where appropriate. Findings showed lifileucel was associated with clinically meaningful and durable responses.
Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
PDUFA date: February 26, 2024
Roluperidone is an investigational 5-HT2A, sigma2 and ??1A-adrenergic receptor antagonist. The NDA submission included data from phase 3 MIN-101 study (ClinicalTrials.gov Identifier: NCT03397134), which evaluated the efficacy and safety of roluperidone in 513 adult patients with moderate to severe negative symptoms of schizophrenia. Findings showed an improvement in negative symptoms (as measured by the Positive and Negative Syndrome Scale PANSS Marder Negative Symptoms Factor Score) in patients receiving roluperidone 64mg compared with placebo.
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