Elvina Almuradova: A New Era in Cancer Treatment – FDA Approves Subcutaneous Nivolumab
Elvina Almuradova, Associate Professor of Oncology at IEO Istituto Europeo di Oncologia, shared a post on LinkedIn:
“A New Era in Cancer Treatment: FDA Approves Subcutaneous Nivolumab.
On December 27, 2024, the U.S. Food and Drug Administration (FDA) approved the subcutaneous (under-the-skin) formulation of nivolumab and hyaluronidase-nvhy (Opdivo Qvantig). This new delivery method enhances patient comfort while maintaining effectiveness and safety comparable to intravenous (IV) administration, offering a flexible treatment alternative.
Approved Cancer Indications:
The subcutaneous form of nivolumab has been approved for use in treatment of the various type cancers, as Renal cell, Melanoma, Non-small cell lung cancer, Head and neck cancers, Urothelial cancers (bladder and urinary tract), Colorectal and hepatocellular (liver) cancers, Gastric and esophageal cancers.
The effectiveness and safety of this new method were evaluated in the CHECKMATE-67T trial involving patients with advanced renal cell carcinoma:
- Efficacy: The overall response rate (ORR) for the subcutaneous form was 24%, compared to 18% for the intravenous version, showing similar effectiveness.
- Pharmacokinetics: Blood concentration levels were comparable between the two formulations.
- Safety: Common side effects included fatigue, musculoskeletal pain, itching, rash, and cough.
However, this formulation is not approved for use in combination with intravenous ipilimumab (Yervoy).
A Milestone in Cancer Therapy:
This approval marks a significant advancement in immunotherapy, providing a patient-friendly approach without compromising efficacy or safety. The subcutaneous formulation simplifies treatment while ensuring reliable results, representing a major step toward improving cancer care.”
Read more on this approval on OncoDaily.
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