- U.S. regulators on Thursday approved a more convenient, subcutaneous version of Roche's cancer therapy Herceptin, clearing the new formulation more than five years after it first became available in Europe.
- Eligible breast cancer patients in the U.S. can now receive Herceptin treatment via an under-the-skin injection rather than an infusion, cutting the time needed to administer the biologic drug to just a few minutes from between a half-hour to an hour and a half previously.
- Herceptin is one of Roche's top-selling drugs and has helped to transform care of breast cancers that over-express a protein known as HER2 — an aggressive subtype of the disease that affects between 15% and 20% of patients.
Herceptin Hylecta (trastuzumb and hyaluronidase-oysk), as the subcutaneous version will be sold, was cleared by the Food and Drug Administration under a new Biologics License Application, rather than as a supplement to Herceptin's approval.
The regulatory thumbs up could help Roche to keep sales from its HER2 breast cancer franchise up in the U.S., where biosimilar competitors to Herceptin are expected to launch later this year. Three of the copycat biologics are already approved by the FDA.
Herceptin (trastuzumab) is a foundational treatment for HER2-positive breast cancer and its success has helped to fuel Roche's. Last year, the biologic therapy ranked as Roche's top earner, pulling in about $7 billion in sales despite weaker performance in Europe due to biosimilar competition.
The subcutaneous version of Herceptin has been approved in Europe since September 2013, and is widely available globally. Yet its arrival in the U.S. has taken longer, a rare state of affairs in an industry that routinely prioritizes the world's largest pharmaceutical market.
"It was a long journey because it wasn't clear the regulator was going to support it," said Roche Pharmaceuticals head Bill Anderson on a recent earnings call. "Then we had a priority on resources in the EU because it was an ongoing launch."
A Phase 3 study called HannaH found the subcutaneous version to be non-inferior to intravenous Herceptin in both neoadjuvant and adjuvant uses, while another late-stage trial showed both formulations to be similarly safe.
The new drug, which uses technology from Halozyme Therapeutics, contains the same monoclonal antibody as intravenous Herceptin along with a recombinant enzyme designed to help delivery via injection.
Roche is also developing a fixed-dose subcutaneous combination of Herceptin and another of its drugs, Perjeta (pertuzumab), with a submission for approval targeted for 2020.
The Swiss pharma currently forecasts that combo, along with Perjeta and Kadcyla (ado-trastuzumab emtansine), to offset biosimilar erosion to Herceptin through 2022.