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FDA Pipeline: What’s New in Biosimilars, Drug Reviews, Designations, and More

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The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations:

Approval for Pegfilgrastim Biosimilar

The FDA recently approved a pegfilgrastim biosimilar, pegfilgrastim-cbqv (Udenyca). The biosimilar has been approved to decrease the incidence of infection as manifested by febrile neutropenia in patients receiving myelosuppressive chemotherapy associated with a clinically significant incidence of febrile neutropenia.

Pegfilgrastim-cbqv was also authorized for marketing in the European Union in September of this year after having received a positive opinion from the European Medicines Agency’s Committee for Human Use in July 2018. 

Breakthrough Therapy Designation for Mitomycin Gel to Treat Patients With Low-Grade Upper-Tract Urothelial Cancer

The FDA has granted Breakthrough Therapy designation to UGN-101 (mitomycin gel) for instillation. UGN-101 is currently in phase III development for the treatment of patients with low-grade upper-tract urothelial cancer. The FDA previously granted both Orphan Drug and Fast Track designations to UGN-101 for use in this setting.

Low-grade upper-tract urothelial cancer is a rare malignant tumor of the cells lining the urinary tract. It most commonly presents in elderly patients who also suffer from comorbid conditions such as hypertension, diabetes, obesity, and metabolic syndrome. Patients diagnosed with the disease typically face either complete removal of the kidney and/or partial removal of the ureter. No therapeutic agent has ever been approved to treat low-grade upper-tract urothelial cancer.

UGN-101 is designed to enable longer exposure of mitomycin to the urinary tract tissue, thereby potentially enabling the treatment of tumors by nonsurgical means. It is delivered to patients using standard intravesical catheters.

The Breakthrough Therapy status for UGN-101 is supported by data from the ongoing phase III OLYMPUS clinical trial which is evaluating the agent for the nonsurgical treatment of low-grade upper-tract urothelial cancer.

Priority Review for Atezolizumab Plus Nab-Paclitaxel for PD-L1–Positive Metastatic TNBC

The FDA has accepted a supplemental biologics license application (sBLA) and granted Priority Review status for atezolizumab (Tecentriq) plus chemotherapy with nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) for the first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer in people whose disease expresses the programmed cell death ligand 1 (PD-L1) protein, as determined by PD-L1 biomarker testing. The FDA is expected to make a decision on approval by March 12, 2019.

The sBLA is based on data from the phase III IMpassion130 study, which was presented at the European Society for Medical Oncology (ESMO) 2018 Congress and published in The New England Journal of Medicine in October 2018.

sNDA, Priority Review for Olaparib Maintenance Therapy in Newly Diagnosed, BRCA-Mutated Advanced Ovarian Cancer

The FDA has accepted a supplemental new drug application (sNDA) for Priority Review for the approval of olaparib (Lynparza) tablets as a maintenance treatment in patients with newly diagnosed, BRCA-mutated advanced ovarian cancer who were in complete or partial response following first-line standard platinum-based chemotherapy. A Prescription Drug User Fee Act (PDUFA) date is set for the first quarter of 2019.

This is the first U.S. regulatory submission acceptance for a poly ADP-ribose polymerase (PARP) inhibitor in the first-line maintenance setting for advanced ovarian cancer. The submission was based on positive results from the pivotal phase III SOLO-1 trial. These data were recently presented for the first time at the ESMO 2018 Congress and published in The New England Journal of Medicine.

Priority Review for Ruxolitinib in Acute Graft-vs-Host Disease

The FDA has accepted for Priority Review an sNDA for ruxolitinib (Jakafi) for the treatment of patients with acute graft-vs-host-disease (GVHD) who have had an inadequate response to corticosteroids. The sNDA submission is based on data from the REACH1 study evaluating ruxolitinib in combination with corticosteroids in patients with acute GVHD who have had an inadequate response to corticosteroids.

The FDA previously granted ruxolitinib Breakthrough Therapy and Orphan Drug designations for the treatment of acute GVHD.

Fast Track Designation for Selinexor in Relapsed or Refractory DLBCL

The FDA has granted Fast Track designation to selinexor, a first-in-class, oral selective inhibitor of nuclear export compound, for the treatment of patients with diffuse large B-cell lymphoma (DLBCL) who have received at least two prior therapies and are not eligible for high-dose chemotherapy with stem cell rescue or chimeric antigen receptor (CAR) T-cell therapy. Selinexor is currently being studied in the ongoing phase IIb SADAL study in patients with relapsed or refractory DLBCL who are not eligible for stem cell transplantation, for which early results will be presented at the upcoming American Society of Hematology (ASH) 2018 Annual Meeting.

Selinexor previously received Fast Track designation as a potential new treatment for patients with pentarefractory multiple myeloma who have received at least three prior lines of therapy. In October 2018, the FDA accepted a new drug application for selinexor seeking accelerated approval as a new treatment for patients with pentarefractory multiple myeloma. The FDA has assigned the drug a Priority Review status and given an action date of April 6, 2019, under the PDUFA.

Orphan Drug Designation for Olaparib in Pancreatic Cancer

The FDA granted Orphan Drug designation to olaparib (Lynparza) for the treatment of pancreatic cancer.

The use of olaparib in pancreatic cancer is being assessed in the ongoing phase III POLO trial, which is testing olaparib as maintenance monotherapy vs placebo in patients with germline BRCA-mutated metastatic pancreatic cancer whose disease has not progressed following first-line platinum-based chemotherapy. Results from the POLO trial are expected in the first half of 2019.

sNDA, Priority Review for Trifluridine/Tipiracil for the Treatment of Metastatic GEJ Adenocarcinoma

The FDA has accepted and granted priority review to the sNDA for trifluridine/tipiracil (Lonsurf) as a treatment for patients with previously treated, advanced, or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction. The FDA has provided an anticipated PDUFA action date of February 24, 2019.

The sNDA is based on data from the global, randomized, double blind pivotal phase III TAGS trial evaluating trifluridine/tipiracil vs placebo and best supportive care in patients with heavily pretreated metastatic gastric/gastroesophageal junction adenocarcinoma that has progressed or who were intolerant to previous lines of therapy. The trial met its primary endpoint of prolonged overall survival and secondary endpoint of progression-free survival, and had continued to demonstrate a consistent safety and tolerability profile. Full results from this study were recently presented at the ESMO 2018 Congress and published simultaneously in The Lancet Oncology.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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