On November 8, 2022 Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, reported that its investigational therapeutic radiopharmaceutical, 177Lu-rhPSMA-10.1, has been awarded an Innovation Passport for the treatment of metastatic castrate-resistant prostate cancer (Press release, Blue Earth Therapeutics, NOV 8, 2022, View Source [SID1234623443]). The Innovation Passport is a designation for innovative medicines and is the entry point to the Innovative Licensing and Access Pathway (ILAP), which aims to accelerate time to market to facilitate patient access. The ILAP aims to achieve this goal by enabling enhanced coordination between sponsors and the UK Medicines and Healthcare products Regulatory Agency (MHRA), leading up to Marketing Authorization Application (MAA) submissions and by providing the opportunity for accelerated MAA reviews. The award was announced by the MHRA in partnership with other ILAP Steering Group members, The All Wales Therapeutics and Toxicology Centre, the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC).
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"We are very pleased to be awarded the Innovation Passport, and believe that it recognizes the patient need for innovative radiopharmaceutical treatments having an optimized therapeutic index such as 177Lu-rhPSMA-10.1 for prostate cancer," said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Therapeutics. "We look forward to working closely with the MHRA and its partner agencies in developing a roadmap that can provide appropriate patients with accelerated access to next generation healthcare treatment."