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FDA Accepts BLA for Subcutaneous Nivolumab in Advanced or Metastatic Solid Tumors

The FDA has accepted a biologics license application for subcutaneous nivolumab for adult patients eligible for approved solid tumor nivolumab indications. ....

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FDA Accepts Biologics License Application for Subcutaneous Formulation of Nivolumab

The new administration method, which is co-formulated with rHuPH20, is usable in previous approved nivolumab indications for solid tumors in adult patients. ....

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FDA to Review Subcutaneous Formulation of Nivolumab

The application is supported by data from the phase 3 CheckMate -67T study. ....

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Bristol Myers Squibb's subcutaneous Opdivo shows promise in kidney cancer

Bristol Myers Squibb's subcutaneous Opdivo shows promise in kidney cancer
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Subcutaneous Nivolumab (nivolumab and hyaluronidase) Shows Noninferiority Compared to Intravenous Opdivo (nivolumab) in Advanced or Metastatic Clear Cell Renal Cell Carcinoma in CheckMate -67T Trial

CheckMate -67T is the first Phase 3 trial of the subcutaneous formulation of Opdivo to evaluate and demonstrate noninferior pharmacokinetics, efficacy and safety vs. its intravenous. ....

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