Genentech's subcutaneous rituximab approved in US

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Roche Rituxan approval

The FDA has approved Genentech’s subcutaneous version of the cancer drug rituximab, allowing for a more convenient injection lasting minutes, rather than several hours.

Branded as Rituxan Hycela, subcutaneous rituximab is administered in combination with hyaluronidase human and is approved for adults with follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukaemia.

The new formulation allows for an administration time lasting five to seven minutes, compared with the lengthy intravenous infusion with the older version branded as Rituxan in the US.

With cheaper biosimilars of the original Rituxan formulation edging closer to the US market, Genentech's owner Roche is looking for ways to maintain sales.

Even though its US patent expired in 2016, the lack of direct competition has helped ensure Rituxan is the company’s biggest selling drug, generating around $7.3 billion in sales last year.

A large chunk of Rituxan’s sales are based in the US and the company hopes that the newer, more patient-friendly formulation will help to maintain its presence in blood cancer should cheaper competition hit the market.

Rituximab biosimilars have already been approved in Europe, where the subcutaneous formulation was approved last year.

The FDA noted that the US label will include the following previously approved uses for Rituxan:

  • Relapsed or refractory, follicular lymphoma (FL) as a single agent.
  • Previously untreated FL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy.
  • Non-progressing (including stable disease), FL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
  • Previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
  • Previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide (FC).

Rituxan Hycela is not approved for use outside oncology.