FDA
4th October 2017

FDA Panel Recommends Approval of Genentech’s rituximab/hyaluronidase Injection

On March 29th, the Oncologic Drugs Advisory Committee (ODAC) discussed biologics license application (BLA) 761064 for rituximab/hyaluronidase injection (Rituximab SC), submitted by Genentech, Inc.

FDA Panel Recommends Approval of Genentech’s rituximab/hyaluronidase Injection

On March 29th, the Oncologic Drugs Advisory Committee (ODAC) discussed biologics license application (BLA) 761064 for rituximab/hyaluronidase injection (Rituximab SC), submitted by Genentech, Inc. (a member of the Roche Group). The proposed indications (uses) for the product include:

  1. Treatment of relapsed or refractory, follicular lymphoma as a single agent
  2. Previously untreated follicular lymphoma, in combination with first-line chemotherapy and, in patients achieving a complete or partial response to rituximab/hyaluronidase for subcutaneous injection in combination with chemotherapy, as a single-agent maintenance therapy
  3. Non-progressing (including stable disease), follicular lymphoma as a single-agent after first-line cyclophosphamide, vincristine, and prednisone
  4. The treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP), or other anthracycline-based chemotherapy regimens
  5. In combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated chronic lymphocytic leukemia (CLL)

Rituximab and Rituximab SC are similarly formulated in that they both utilize the same monoclonal antibody, but Rituximab SC can be administered in 5-7 minutes, compared to the 1.5 + hours for the intravenous Rituximab product. Rituximab SC’s shortened administration time is attributed to not only the SC route of administration but also the inclusion of recombinant human hyaluronidase (rHuPH20), an enzyme that increases tissue permeability, therefore allowing Rituximab SC to be absorbed more readily.

Rituximab SC provides a benefit to patients with these blood cancers because the product eliminates the burden of having the patient remain bedside through IV infusions that could potentially last hours. Rituximab SC’s reduced administration time will enable healthcare providers to treat higher volumes of patients, without negatively impacting quality of treatment.

Genentech’s data package consisted of results from five studies, which represented a total population of more than 2,000 individuals. Included in these studies were individuals with blood cancers for which IV Rituximab is approved. Safety and efficacy data were used from studies conducted with the previously approved EU product, but Genentech utilized a pharmacokinetic-clinical bridging strategy. This is a common regulatory approach to apply the known effectiveness of an approved product to a new formulation, in this case, the Rituximab IV product to the new formulation of the Rituximab SC product. Genentech expanded the framework of their bridging approach to include the following: (1) Establish non-inferiority exposure; (2) Establish comparability of effectiveness and safety; (3) Evaluate patient satisfaction/preference for route of administration.

The voting question posed to the committee was “Is the benefit-risk favorable for the above drug product for the proposed indications in follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL)?” As Genentech established comparable safety and efficacy of Rituximab SC to Rituximab IV, and identified a clear patient preference to Rituximab SC (~80% compared to Rituximab IV), the committee unanimously voted in favor of the benefit-risk in an 11-0 result for all proposed indications. Committee members noted in the discussion portion of the meeting that the data package presented by Genentech was very compelling and that the SC formulation will positively impact treatment programs for patients.

On June 23rd, 2017, the FDA approved Rituximab SC for the treatment of previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), and previously untreated and previously treated chronic lymphocytic leukemia (CLL).

Innovative Science Solutions (ISS) was proud to assist in providing regulatory insight and knowledge to Genentech throughout the Rituximab SC FDA Advisory Committee Meeting process. ISS has almost two decades of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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