GB first to approve Roche's subcutaneous Tecentriq


The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has become the first regulator to approve Roche's subcutaneous (SC) formulation of cancer immunotherapy Tecentriq, which aims to make treatment easier for patients.

The approval covers all indications for the current intravenous (IV) version of Tecentriq across lung, bladder, breast, and liver cancers, and Roche confirmed this morning that the new version will be provided by the NHS in England.

"We couldn’t have achieved this without the collaboration and support of stakeholders across the cancer community and we remain committed to ensure this treatment is available in Scotland, Wales and Northern Ireland as quickly as possible," said Marius Scholtz, medical director of Roche Products Limited.

Dosing with the SC version takes around seven minutes, while the current IV form requires a 30- to 60-minute infusion, so transitioning to the new form should save time for patients and healthcare staff and conserve resources in healthcare systems, according to Roche.

The MHRA approval covers England, Scotland, and Wales, while at the moment registration in Northern Ireland comes under the remit of the EMA, which has yet to make a decision on the new product. SC Tecentriq is currently under review in the EU, as well as in the US and other countries worldwide.

Last year, Tecentriq became the first SC drug in the PD-1/PD-L1 inhibitor class to clear a multinational phase 3 trial, matching the original formulation in the head-to-head IMscin001 study that involved immunotherapy-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who had previously been treated with platinum-based chemotherapy.

The results showed comparable levels of Tecentriq in the blood when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation.

So far, approved PD-1/PD-L1 inhibitors headed by MSD's Keytruda (pembrolizumab) and Bristol-Myers Squibb's Opdivo (nivolumab) are all given by IV – other than a product brought to market within China only – so have fought for market share based on their clinical indications.

Now, Roche can add ease of administration to the competitive profile of Tecentriq, and extend the commercial lifespan of the drug with further patent protection. The company said that, while the IMscin001 trial was conducted within hospital settings, SC Tecentriq may be suitable for out-of-hospital administration as well.

Its rivals are not sitting still, however, with MSD and BMS both working on SC versions of their drugs in late-stage trials and Pfizer testing an experimental SC antibody, called sasanlimab, in the phase 3 CREST trial in bladder cancer, with results due next year.

Roche's new drug has been developed using Halozyme's Enhanze drug delivery technology, which has already been deployed in the big pharma's Herceptin (trastuzumab), Rituxan (rituximab), and Phesgo (pertuzumab/trastuzumab) product lines and is being used to create a new version of multiple sclerosis therapy Ocrevus (ocrelizumab).