Roche welcomes FDA approvals for injectable versions of MS and cancer drugs

Biologic drugs are usually given as an infusion, which can take an hour or more. The FDA has approved injectable versions of two of Roche's biologic drugs, one for multiple sclerosis and the other for cancer. Both shorten the administration time to a patient to just a few minutes.

Approval has been granted for the cancer drug Tecentriq Hybreza, a subcutaneously injectable version of Roche's Tecentriq immunotherapy. It is administered every three weeks by a seven-minute injection in the thigh. By comparison, Tecentriq's intravenous infusion takes about 30 to 60 minutes. Tecentriq generated sales of 3.8 billion Swiss francs (about $4.4 billion) in 2023. The September 12 approval of Tecentriq Hybreza covers all cancer indications listed in the package insert for the infused version of the drug, including lung cancer, melanoma and hepatocellular carcinoma.

The FDA approval of Tecentriq Hybreza is based on the results of an open-label study whose primary goal was to measure the drug's exposure in the body. The study also evaluated other measures such as overall response rate. Results showed that the injectable version was roughly comparable to the infused drug. The most common side effects of Tecentriq Hybreza are fatigue, musculoskeletal pain, cough, shortness of breath and loss of appetite.

“By enabling subcutaneous administration of cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancers and their physicians more flexibility and choice in how treatment is administered,” said Levi Garraway, Roche's chief medical officer and head of global product development, in a prepared statement. “We are excited to introduce this new subcutaneous formulation, which builds on the established safety and efficacy profile of intravenous Tecentriq and can treat patients more quickly and in more accessible settings.”

Subcutaneous Tecentriq is approved in more than 50 countries. Outside the United States, the product is marketed under the name Tecentriq SC. Roche said regulatory review of this drug is ongoing in additional markets.

FDA approval of MS drug Ocrevus Zunovo came one day after the cancer drug was approved. Like injectable Ocrevus, injectable Ocrevus Zunovo treats patients with relapsing and progressive forms of MS. The injection is given every six months, just like Ocrevus. However, Ocrevus Zunovo is given as a 10-minute subcutaneous injection, as opposed to a two-hour infusion like Ocrevus, plus one-hour monitoring after the infusion. Patients who choose the injectable MS drug will need to be monitored for one hour after the first dose, but subsequent doses only require 15 minutes of monitoring.

The FDA approval of Ocrevus Zunovo is based on data from a Phase 3 study that compared the injectable drug with that given by infusion. The results showed no clinically significant difference in blood drug levels. The safety profile of the injection was also consistent with that of intravenous Ocrevus. The most common side effect reported in the study was injection reactions, mostly after the first injection. All of these reactions were considered mild to moderate, and none caused patients to discontinue treatment.

Ocrevus had sales of 6.4 billion Swiss francs (about $7.5 billion) last year. The injectable version of the drug will help Roche compete against MS drugs from Novartis and TG Therapeutics. Novartis' Kesimpta is available in the form of self-injection pens that patients take monthly. TG Therapeutics' Briumvi is a one-hour infusion, but the dosing interval is every six months.

Both Ocrevus Zunovo and Tecentriq Hybreza are made using Halozyme Therapeutics' Enhanze, a drug delivery technology that enables biologic drugs to be administered as injections.

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