Biologic drugs are typically given as infusions that can take an hour or longer. The FDA has approved injectable versions of two biologic Roche drugs, one for multiple sclerosis and the other for cancer. Each one shaves a patient’s dosing time down to minutes.
The cancer drug approval went to Tecentriq Hybreza, a subcutaneously injectable version of the Roche immunotherapy Tecentriq. Dosing is a seven-minute injection in the thigh every three weeks. By comparison, IV infusion of Tecentriq takes about 30 to 60 minutes. Tecentriq accounted for 3.8 billion Swiss francs (about $4.4 billion) in 2023 revenue. The Sept. 12 approval of Tecentriq Hybreza covers all of the adult cancer indications included in the label for the infused version of the drug, which include lung cancer, melanoma, and hepatocellular carcinoma.
The FDA approval of Tecentriq Hybreza is based on the results of an open-label study whose main goal was to measure exposure of the drug in the body. The study also assessed other measures such as overall response rate. Results showed the injectable version was roughly comparable to the infused drug. The most common adverse reactions to Tecentriq Hybreza include fatigue, musculoskeletal pain, cough, shortness of breath, and loss of appetite.
The Funding Model for Cancer Innovation is Broken — We Can Fix It
Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches.
“By enabling subcutaneous administration for a cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration,” Levi Garraway, Roche’s chief medical officer and head of global product development, said in a prepared statement. “We are pleased to introduce this new subcutaneous formulation that builds on the established safety and efficacy profile of intravenous Tecentriq and can treat patients faster and in more accessible settings.”
Subcutaneous Tecentriq has been approved in more than 50 countries. Outside the U.S., the product is marketed as Tecentriq SC. Roche said regulatory review of this drug is ongoing in additional markets.
FDA approval of the MS drug, Ocrevus Zunovo, came the day after the cancer drug approval. Like infused Ocrevus, injectable Ocrevus Zunovo treats patients who have relapsing and progressive forms of MS. The injection is administered every six months, just like Ocrevus. But Ocrevus Zunovo is dosed as a 10-minute subcutaneous injection versus a two-hour infusion for Ocrevus, plus one hour of post-infusion monitoring. Patients who opt for the injectable MS drug will need to be monitored for one hour after the first dose, but subsequent doses require just 15 minutes of monitoring.
FDA approval of Ocrevus Zunovo is based on data from a Phase 3 study that compared the injectable drug to the infused one. Results showed no clinically significant difference in levels of the drug in the blood. The safety profile of the injection was also consistent with IV-infused Ocrevus. The most common adverse event reported in the study was injection reactions, mostly following the first injection. All of these reactions were classified as mild to moderate and none of them led patients to stop treatment.
Market Trends to Watch for Health Systems and Their Specialty Pharmacies
The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients.
Ocrevus accounted for 6.4 billion Swiss francs (about $7.5 billion) in revenue last year. The injectable version of the drug will help Roche compete against MS medicines from Novartis and TG Therapeutics. Novartis’s Kesimpta is available in 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 with Halozyme Therapeutics’ Enhanze, a drug delivery technology that enables biologic drugs to be administered as injections.
Photo: Giuseppe Aresu/Bloomberg, via Getty Images