FDA Approves Subcutaneous Opdivo Qvantig for Solid Tumors

On Friday, January 3, 2025, the U.S. Food and Drug Administration (FDA) announced the approval of Opdivo Qvantig, a new injection for the treatment of solid tumors in adults. This new formulation includes nivolumab and hyaluronidase-nvhy and is designed for subcutaneous administration. It encompasses most of the previously approved indications for Opdivo, either as a standalone treatment, as a maintenance therapy following a combination with Yervoy (ipilimumab), or in conjunction with chemotherapy or cabozantinib.

Opdivo Qvantig is a blend of nivolumab and recombinant human hyaluronidase. The approval of this new product was largely based on evidence from the phase 3 randomized, open-label CheckMate-67T trial. This trial established that Opdivo Qvantig is not inferior to intravenous Opdivo in terms of the primary endpoints, which included the time-averaged concentration over 28 days and the minimum concentration at a steady state. Furthermore, the trial revealed an overall response rate of 24% for Opdivo Qvantig, compared to an 18% response rate for the intravenous version of Opdivo.

For over ten years, Opdivo has been a significant player in the field of immunotherapy, addressing various tumor types. Adam Lenkowsky, the executive vice president and chief commercialization officer at Bristol Myers Squibb, expressed enthusiasm over the approval. He emphasized the potential benefits for cancer patients who can now receive their treatment via a quicker delivery method.

The FDA's approval of the subcutaneous version of Opdivo Qvantig represents a significant step forward for Bristol Myers Squibb, the pharmaceutical company responsible for its development. This new method of administration is expected to enhance the convenience and experience of cancer treatment for patients.

This development marks a significant milestone in cancer treatment, offering a more accessible and efficient way for patients to receive their medication. The subcutaneous administration of Opdivo Qvantig provides a faster alternative to intravenous treatments, potentially improving the quality of life for those undergoing cancer therapy.

With the new approval, Bristol Myers Squibb continues to demonstrate its commitment to advancing cancer treatments and providing innovative solutions for patients facing various cancer diagnoses. The introduction of Opdivo Qvantig into the market reinforces the company's ongoing efforts to improve patient care through cutting-edge medical advancements.