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FDA Pipeline: Approval of New Dosing for Biosimilar, Plus Two Fast Track Designations


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The U.S. Food and Drug Administration (FDA) recently approved a new dose for a biosimilar referencing trastuzumab and granted Fast Track designations to agents for patients with urothelial cancer and follicular lymphoma.

Approval of Multidose Vial of Trastuzumab Biosimilar

The FDA approved a 420-mg multidose vial of trastuzumab-dttb (Ontruzant), a biosimilar referencing trastuzumab.

Trastuzumab-dttb was first approved as a 150-mg single-dose vial by the FDA in January 2019 across all eligible indications—namely, for the adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease.

Fast Track Designation for IPI-549 in Advanced Urothelial Cancer

The FDA granted Fast Track designation for IPI-549, a first-in-class, oral treatment that selectively inhibits PI3K-gamma, in combination with nivolumab for the treatment of advanced urothelial cancer. MARIO-275, an ongoing global, randomized, controlled phase II study, is currently enrolling patients to evaluate IPI-549 in combination with nivolumab in platinum-refractory, immunotherapy-naive patients with advanced urothelial cancer.

The study will enroll approximately 160 checkpoint inhibitor–naive patients with advanced urothelial cancer who have had disease progression or recurrence following treatment with platinum-based chemotherapy. Patients will be randomly assigned 2:1 to receive IPI-549 plus nivolumab or nivolumab plus placebo. The primary objective of the study is objective response rate as measured by Response Evaluation Criteria in Solid Tumors, version 1.1; secondary objectives include time to response, duration of response, and progression-free survival.

Fast Track Designation for ME-401 in Adult Patients With Relapsed or Refractory Follicular Lymphoma

The FDA granted Fast Track designation to ME-401, an investigational selective oral inhibitor of phosphatidylinositol 3-kinase (PI3K) delta for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies, including chemotherapy and an anti-CD20 antibody.

ME-401 is currently being evaluated in TIDAL (Trials of PI3K DeltA in Non-Hodgkin Lymphoma), a phase II trial.

ME-401 is in clinical development for the treatment of B-cell malignancies.

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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