The drug, Gavreto, or pralsetinib, won accelerated approval for RET fusion-positive non-small cell lung cancer, with or without prior therapy, while the FDA accepted the company's approval application for the drug in two types of thyroid cancer. The approval follows the May nod for Eli Lilly's Retevmo for all three indications.
Under the deal, Blueprint will additionally be eligible for more than $900M in milestone payments plus royalties for the RET inhibitor pralsetinib. The deal includes exclusive rights for Roche in ex-U.S. markets other than China and shared rights in the U.S.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Phase I/II data for pralsetinib in non-small cell lung cancer are the subject of a poster presented at the ASCO meeting. An expert noted the similarity between its clinical activity and that of Lilly's drug, Retevmo. Both are RET inhibitors.
The company will present a poster on pralsetinib, its RET inhibitor, which some analysts wrote they view as being "interchangeable" with Lilly's Retevmo, which received accelerated FDA approval last week.
The biotech company announced data from its Phase I/II study of pralsetinib in RET fusion-positive non-small cell lung cancer and kicked off a rolling submission for FDA approval. Eli Lilly Oncology announced data for its own RET inhibitor in September.
Analysts nevertheless wrote that with each data update, Lilly's RET inhibitor LOXO-292 (selpercatinib) appears less differentiated on efficacy as well as tolerability from Blueprint Medicines' BLU-667 (pralsetinib).
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.