- Roche won’t be able to launch a subcutaneous version of its cancer immunotherapy Tecentriq until 2024 because it needs extra time to gain Food and Drug Administration approval.
- The delay in the U.S. will not affect regulatory decisions elsewhere nor a U.K. approval of the under-the-skin formulation, according to Roche and its development partner, Halozyme Therapeutics. A Roche spokesperson said the company is making “updates to our chemistry, manufacturing and controls ... processes in line with evolved FDA requirements.”
- Shifting Tecentriq, currently administered by intravenous infusion, to a subcutaneous injection could help Roche extend its market position by several years as a key patent on the IV version expires in 2028. Tecentriq had sales of 3.7 billion Swiss francs, or about $3.9 billion, in 2022.
Many makers of so-called PD-1 cancer immunotherapies aim to develop under-the-skin versions of their drugs. But Roche got there first, winning an approval last month from the U.K.’s Medicines and Healthcare Products Regulatory Agency.
Subcutaneous administration is much faster than via IV: According to Halozyme, delivery takes just seven minutes compared to the 30 to 60 minutes needed for intravenous Tecentriq.
Tens of billions of dollars in sales are at stake. Merck & Co.’s Keytruda and Bristol Myers Squibb’s Opdivo are both due to lose U.S. patent protection in 2028, and a switch to subcutaneous injection could help protect their revenue streams well into the 2030s.
For Merck in particular, that shift could be crucial: The cancer drug accounted for $21 billion of its $52 billion in pharmaceutical sales in 2022.
Last year, Roche reported that subcutaneous Tecentriq, when used in lung cancer patients, resulted in similar blood levels as the intravenously administered version. Merck has run a similar study with subcutaneous Keytruda. Results are highly anticipated and could come shortly.
Bristol Myers, meanwhile, discontinued work with a subcutaneous Opdivo autoinjector. It has a standard syringe and vial version in a clinical study comparing it to the IV version that could also read out soon.