FDA approves first-in-class cancer checkpoint inhibitor

Words by GOLD newsdesk

A new type of checkpoint inhibitor to treat unresectable or metastatic melanoma has been approved by the FDA – the first approval of this kind in eight years.


Developed by Bristol Myers Squibb (BMS), the first-in-class Opdualag is a fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab. It is administered as a single intravenous infusion and is used to treat patients aged 12 years or older who weigh at least 40kg.


In its Phase 2/3 RELATIVITY-047 trial, Opdualag more than doubled median progression-free survival compared to nivolumab monotherapy – an established standard of care.


Commenting on BMS’ progress in the treatment of advanced melanoma over the past decade, Samit Hirawat, Chief Medical Officer, Global Drug Development, BMS, said: “Inhibiting LAG-3 with relatlimab, in a fixed-dose combination with nivolumab, represents a new treatment approach that builds on our legacy of bringing innovative immunotherapy options to patients. The approval of a new medicine that includes our third distinct checkpoint inhibitor marks an important step forward in giving patients more options beyond monotherapy treatment.”


The approval has been welcomed by many across the healthcare sector, with Michael Kaplan, president and CEO, Melanoma Research Alliance, commenting that it “is an important step forward for patients with melanoma. It is especially rewarding to see a LAG-3 therapeutic – discovered in part through work funded by MRA – now become available to patients in the clinic.”


This application was approved under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.


Cancer collaboration


BMS has also announced it is to leverage oncology company Volastra Therapeutics' proprietary CINtech platform to discover, develop and commercialise oncology drug candidates.


“The combination of Bristol Myers Squibb’s expertise in oncology and Volastra’s deep understanding of chromosomal instability as cancer’s Achilles' heel makes for an ideal partnership to advance novel therapies for patients,” said Charles Hugh-Jones, Chief Executive Officer, Volastra.


Volastra is set to receive an upfront payment of $30m, with the potential for an additional $1.1bn in development, regulatory and commercial milestone payments, as well as royalties.