publication date: Oct. 12, 2018

Drugs & Targets

ODAC recommends approval of rituximab biosimilar

The FDA Oncologic Drugs Advisory Committee voted unanimously 16-0 to recommend approval of CT-P10, a proposed monoclonal antibody biosimilar to Rituxan (rituximab) for the treatment of adult patients in three proposed indications.

The proposed indications are:

Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell Non-Hodgkin’s Lymphoma as a single agent;

Previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and

Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy.

The committee based its recommendation on a review of a comprehensive data package inclusive of foundational analytical biosimilarity data, nonclinical data, clinical pharmacology, immunogenicity and clinical efficacy and safety data. The results of the clinical development program for CT-P10 demonstrated that there were no clinically meaningful differences between CT-P10 and Rituxan in terms of the safety, purity and potency of the product for the three proposed indications.

Celltrion Inc. and Teva Pharmaceutical Industries Ltd. entered into an exclusive partnership in October 2016 to commercialize CT-P10 in the U.S. and Canada.


Myriad, Pfizer announce commercialization plan for talazoparib companion diagnostic

Myriad Genetics Inc. and Pfizer Inc. announced a commercialization plan under an existing companion diagnostic agreement, in which Myriad is pursuing FDA approval for its BRACAnalysis CDx to be used as a companion diagnostic with Pfizer’s investigational PARP inhibitor, talazoparib.

Talazoparib and BRACAnalysis CDx currently are under FDA review, with New Drug Application and Supplementary Premarket Approval submissions based on results from … Continue reading ODAC recommends approval of rituximab biosimilar

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