Biologic drugs, traditionally administered via lengthy infusions, are now seeing revolutionary advancements with the FDA’s approval of injectable forms that drastically reduce treatment duration. Roche has successfully transformed two of its biologics into injectable versions, one targeting multiple sclerosis (MS) and the other, cancer, thus reducing patient dosing time from hours to minutes.
The newly approved cancer drug, Tecentriq Hybreza, is a subcutaneous injectable format of Roche’s existing immunotherapy, Tecentriq. Designed for every three-week administration, Tecentriq Hybreza can be injected in just seven minutes into the thigh, compared to the 30-60 minutes required for its intravenous (IV) counterpart. The drug, which generated revenues of 3.8 billion Swiss francs (around $4.4 billion) in 2023, has been approved for the same range of cancer treatments as the IV form, including major indications like lung cancer, melanoma, and hepatocellular carcinoma.
The efficacy and safety of Tecentriq Hybreza were confirmed by an open-label study focusing on the drug’s exposure levels within the body along with other metrics like overall response rate. The injectable was found to be comparable to the infused version in terms of effectiveness, with common adverse reactions including fatigue, musculoskeletal pain, cough, shortness of breath, and loss of appetite. Highlighting the benefits, Roche’s chief medical officer Levi Garraway emphasized the greater flexibility and treatment accessibility this injectable form provides to patients across multiple cancer types, maintaining the proven safety and efficacy profile of the IV form.
Roche’s MS drug, Ocrevus Zunovo, granted FDA approval a day after Tecentriq Hybreza, offers a similar transition from IV infusion to subcutaneous injection. Ocrevus Zunovo, treating relapsing and progressive forms of MS, is administered biannually as a 10-minute injection, substituting the considerably longer two-hour IV infusion required by the original Ocrevus formula. Though post-injection monitoring times vary, they are markedly shorter than those required post-infusion. Phase 3 trial data underscored no significant differences in drug levels between the injected and infused versions, and the injection’s safety profile aligned with that of the original, with most adverse events reported as mild to moderate and not leading to discontinuation of treatment.
Ocrevus, vastly successful with 6.4 billion Swiss francs (about $7.5 billion) in revenues, faces competition in the MS treatment landscape from Novartis’s Kesimpta and TG Therapeutics’ Briumvi. However, its new injectable version offers a competitive edge with its considerably reduced administration time and reduced frequency of treatments.
Both Ocrevus Zunovo and Tecentriq Hybreza utilize Halozyme Therapeutics’ Enhanze technology, which enables biologic drugs to be administered as injections, enhancing patient convenience and potentially improving adherence to treatment regimens. This technological advancement marks a significant shift in how biologic therapies can be delivered, demonstrating a broader trend in pharmaceutical innovation aimed at improving patient care and treatment efficiency.
As these drugs gain wider approval and see more use globally, they promise significant impacts on patient treatment experiences by offering quicker, less invasive administration options without sacrificing efficacy. This could potentially reshape treatment protocols in both cancer and multiple sclerosis therapies, offering patients not just medical benefits but also an improved quality of life through simpler, faster dosing schedules.
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