The Subcutaneous (SC) Revolution in Oncology: FDA Approvals and the Latest Developments
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The process that began with Rituximab has reached its peak with Keytruda and Rybrevant. In cancer treatment, intravenous infusions lasting hours are giving way to subcutaneous injections taking minutes.
In cancer treatment, patients' quality of life is as critical a measure of success as efficacy (shrinking the tumor). In medicine, there is a concept called "Time Toxicity" : the hours patients spend in hospitals waiting for drugs through an intravenous line are time taken away from their social lives. The "subcutaneous (SC)" formulation revolution, which has accelerated over the past 10 years, is giving patients their freedom back by reducing this time from hours to minutes. In this article, we examine the technological background of this major transformation, the patent battles, and the latest developments as of 2026.
Behind the Scenes: Why Are Drugs Moving from Intravenous (IV) to Subcutaneous (SC) Administration?
Behind this great "formulation battle" in oncology lie not just convenience but enormous technological and commercial strategies. Here are the 4 main reasons:
Normally, no more than 2 ml of fluid can be given subcutaneously. However, Halozyme (ENHANZE) technology uses the enzyme "recombinant human hyaluronidase (rHuPH20)" to temporarily loosen subcutaneous tissue, enabling large drug volumes such as 10-15 ml to be absorbed within minutes. This is the engine of the revolution.
While a chemotherapy unit reserves a chair for 3-4 hours for a patient receiving an IV drug, a patient receiving an SC drug can be discharged in 10 minutes. This increases hospitals' capacity by 5-10 times and reduces waiting lists.
Finding a vein during prolonged treatments can become an ordeal, or a permanent port/catheter may be needed (infection risk). SC formulations eliminate these problems with a simple injection into the abdomen/thigh. Systemic infusion reactions (chills, fever) are also much less common with SC formulations.
This is where the commercial secret lies. Just before a biological drug's patent (for example, Herceptin or Keytruda) expires and inexpensive "biosimilar" competitors enter the market, the company develops an SC formulation and obtains a new patent. This preserves its market share. In the industry, this is known as the "Evergreening" (an evergreen tree / keeping something continually alive) strategy.
A Timeline of the Transformation: The SC Revolution from Rituximab to Today
Whereas the first SC formulations took 10-15 minutes, administration times have now fallen to as little as 2 minutes. Here is that historical journey shaped by FDA approvals:
The first major SC transformation in oncology. It reduced hours-long infusions in lymphoma treatment to minutes.
Time: 5-7 MinutesIt brought great convenience to HER2-positive breast cancer patients. While the IV formulation took 90 minutes, the SC formulation was revolutionary.
Time: 2-5 MinutesTwo major breast cancer antibodies combined in a single injection. It opened the door to "home treatment" during the pandemic.
Time: 5-8 MinutesIt changed standards in multiple myeloma. While the IV infusion takes up to 7 hours, the SC formulation is administered within minutes.
Time: 3-5 MinutesA First: The first FDA-approved SC formulation of a PD-L1 inhibitor (immunotherapy). Demonstrated in the IMscin001 study.
Time: ~7 MinutesIts efficacy was demonstrated in the CheckMate-67T study. Immunotherapy's most widely used drug is now subcutaneous.
Time: < 5 MinutesThe world's best-selling cancer drug. Developed under the code MK-3475A. It is the fastest, with a high-dose option every 6 weeks.
Time: ~2 Minutes (The Fastest)The initial approval that ended the ordeal of a 5-hour infusion in lung cancer. Administration every 2 weeks, based on the PALOMA-3 study.
Time: 7 MinutesThe Latest Development: Rybrevant Faspro and the Convenience of "Monthly" Dosing
The latest link in this revolution came from Johnson & Johnson's drug for EGFR-mutated non-small cell lung cancer (NSCLC), Rybrevant Faspro (Amivantamab + Hyaluronidase). Following its initial approval in December 2025, data from the PALOMA-2 study enabled the convenience of once-monthly administration during maintenance treatment.
| Feature | Previous Method (IV Infusion) | New Method (SC - Monthly) |
|---|---|---|
| Duration | 2 - 5 Hours | ~7 Minutes |
| Frequency | Every 2 Weeks | Every 4 Weeks (Maintenance) |
| Risk of Reactions | High (67%) | Low (12% - 5 times lower) |
| Response Rate | Reference | 82% - 87% (Equivalent) |
Conclusion: The study demonstrated that subcutaneous administration achieves the same blood levels (pharmacokinetics) as intravenous administration, but is far superior in terms of adverse effects (particularly infusion reactions and clotting risk) and convenience.
DRÖZDOĞAN Academy Commentary
In oncology, "speed" used to refer only to the tumor's growth rate; now it also refers to the speed of treatment. Keytruda's administration time falling to 2 minutes and Rybrevant's frequency falling to once a month signal that cancer treatment is moving from an "extraordinary situation" to a "manageable routine", like diabetes.
Yes, behind this transformation there is also companies' concern about extending their patent terms (evergreening). Whatever the reason, however, the result is tremendous convenience for our patients. The difficult days of searching for a vein in hospital are giving way to days when a short injection lets people return to life. This is technology at its finest in the service of human dignity.
References
- FDA Approves Monthly Dosing of Rybrevant Faspro for NSCLC - Medscape Medical News (Feb 2026).
- FDA Approval of Subcutaneous Amivantamab (Dec 2025).
- Subcutaneous Immunotherapy: CheckMate-67T (Nivolumab) and MK-3475A (Pembrolizumab) Clinical Data.
- Johnson & Johnson PALOMA-2 and PALOMA-3 Study Results.
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