On 27 January 2023, Lilly announced the approval of pirtobrutinib by the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.
More recently, in April 2023, the drug also received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP).
Pirtobrutinib, is a highly selective kinase inhibitor and is the first and only FDA approved non-covalent (reversible) BTK inhibitor available.
The drug, formerly known as RXC005, was discovered by Dr. Nicolas Guisot, vice president, drug discovery and the team at Redx.
RXC005 was divested to Loxo Oncology in July 2017.
“The approval of pirtobrutinib is a testament to the potential of the UK biotech industry to discover important new treatments for unmet medical needs,” said Steve Bates OBE, chief executive officer at UK BioIndustry Association.
“The team at Redx should be incredibly proud to have originated a molecule that has made it to market given that fewer than 5% of preclinical projects currently achieve this milestone.
“It also serves to highlight that an FDA approval is the culmination of years of work, requiring significant investment, which often forces the UK biotech community to secure partnerships and investment from outside the UK so their research can become reality.
“With its world-class innovation capabilities, of which pirtobrutinib offers a shining example, the UK can be a real force in the global biotech market and greater financial and political support from within will help ensure more of the ultimate returns are captured by the UK economy.”
Lisa Anson, chief executive officer at Redx Pharma added that the achievement showcases what the UK biotech industry is capable of and the need to “nurture and support innovation”.
At the plaque unveiling, Anson was joined by CSO, Dr. Richard Armer, and Dr. Kath Mackay, director of life Sciences, Bruntwood SciTech, who all spoke before the event.
