FDA Action Alert: BMS, TG, Spero and Merck

FDA_Sarah Silbiger/Getty Images

Sarah Silbiger via Getty Images

The U.S. Food and Drug Administration has a handful of PDUFA dates over the next two weeks. Here's a closer look. 

BMS's Breyanzi for R/R Large B-Cell Lymphoma

Bristol Myers Squibb has a target action date of June 24 for the supplemental Biologics License Application (sBLA) for Breyanzi for the treatment of adults with relapsed or refractory large B-cell lymphoma after failure of first-line therapy. The sBLA is built on data from the Phase III TRANSFORM trial.

Breyanzi (lisocabtagene maraleucel) is a CD19-directed chimeric antigen receptor (CAR) T-cell therapy. It is indicated for adults with r/r DLBCL after two or more lines of systemic therapy, including diffuse DLBCL not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma graded 3B.

The TRANSFORM study compared the drug as second-line therapy to the standard of care of salvage chemotherapy followed by high-dose chemotherapy plus autologous hematopoietic stem cell transplant. The data provided highly statistically significant and clinically meaningful improvements in event-free survival, complete responses and progression-free survival, and a positive trend in overall survival in patients with LBCL whose disease was primary refractory or relapsed within 12 months after first-line therapy.

TG Therapeutics' U2 for CLL and SLL

TG Therapeutics originally had a target action date of April 22 for a meeting of the FDA's Oncologic Drugs Advisory Committee (ODAC) to review its BLA and supplemental New Drug Application (sNDA) for the combination of ublituximab and Ukoniq (umbralisib), referred to as U2, for treatment of adults with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The company announced that the FDA had extended the PDFUA date to June 25.

The submissions were based on data from the UNITY-CLL Phase III study of U2 compared to an active control arm of Obinutuzumab plus chlorambucil in patients with both treatment-naïve and relapsed or refractory CLL. The primary endpoint was superior progression-free survival (PFS) for U2 compared to the control arm, which it met, significantly prolonging the independent review committee assessed PFS versus control, 31.9 months versus 17.9 months, at a median follow-up of 36.7 months.

Then, on April 15, the company voluntarily withdrew the BLA/sNDAs based on recently updated overall survival (OS) data from the UNITY-CLL trial showing an increasing imbalance in OS. TG also voluntarily withdrew Ukoniq from sale for approved indications of adults with marginal zone lymphoma (MZL) who had received at least one previous anti-CD20-based regimen and adults with follicular lymphoma (FL) who had received at least three previous systemic therapies.

Spero's Tebipenem for Urinary Tract Infections

Spero Therapeutics has a target action date of June 27 for its NDA for tebipenem HBr oral tablets for adults with complicated urinary tract infections (cUTI), including acute pyelonephritis caused by susceptible microorganisms. The drug has been granted Qualified Infectious Disease Product (QIDP), Fast Track, and Priority Review designations for these indications. The submission includes data from the Phase III ADAPT-PO trial, which hit the primary endpoint of demonstrating the drug was statistically non-inferior to intravenous ertapenem in treating these patients. The drug is being developed as the first oral carbapenem antibiotic for use in cUTI.

Merck's Pneumococcal Vaccine

Merck has a target action date of July 1 for its supplemental BLA for Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) in infants and children, specifically for the prevention of invasive pneumococcal disease in children six weeks through 17 years of age. It is under Priority Review.

The vaccine consists of purified capsular polysaccharides from S. pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F individually conjugated to CRM197 carrier protein. It is currently approved for adults 18 years and older for the prevention of invasive diseases caused by the S. pneumoniae serotypes contained in the vaccine.

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