The Food and Drug Administration on Friday approved medicines from Eli Lilly and Italy’s Menarini Group for a type of advanced lymphoma and a specific kind of metastatic breast cancer, respectively.
The two drugs join a long list of new cancer therapies cleared by the FDA, which over the past five years has granted approvals to more than six dozen treatments for a wide array of malignancies.
Lilly’s and Menarini’s treatments are notable in their own right, too. Lilly’s drug, which will be sold as Jaypirca, is the fourth drug of its type, targeting a protein known as Bruton’s tyrosine kinase to treat relapsed or refractory mantle cell lymphoma. But it works differently than the three cleared before it, binding to that protein reversibly rather than irreversibly. It’s cleared for use after other BTK inhibitors and, according to Lilly, could help patients in whom those other drugs no longer work.
Lilly, which priced Jayprica at $21,000 for a 30-day supply, said the drug will be available in the “coming weeks.”
Menarini’s treatment, called Orserdu, is also the newest member of an established drug class, becoming the first oral treatment that works by selectively degrading estrogen receptors. The FDA approved it for postmenopausal women or adult men who have advanced or metastatic breast cancer that’s estrogen receptor positive but negative for a protein called HER2. Eligible patients must have tried at least one prior endocrine therapy and seen their cancer progress.
The FDA limited Orserdu’s use to only those patients whose tumors harbor a mutation in a gene called ESR1, however. In clinical testing, the benefit to Orserdu treatment appeared strongest in these patients.
A spokesperson for Stemline Therapeutics, the Menarini subsidiary that will sell Orserdu in the U.S., said a 30-day supply of the drug will cost $21,369 at wholesale acquisition cost.
Both Jaypirca and Orserdu came to their current owners via dealmaking. Jaypirca was originally developed by the small British biotechnology company Redx Pharma, which sold the drug to U.S.-based Loxo Oncology for $40 million. In 2019, Lilly spent $8 billion to acquire Loxo for a targeted drug now approved as Retevmo, as well as Jaypirca.
Former Loxo Oncology executive Jacob Van Naarden is now head of the Indianapolis pharmaceutical company’s “Loxo@Lilly” division.
Menarini, meanwhile, licensed rights to Orserdu in 2020 from the company Radius Health, which was taken private last year by two investment firms.
Its approval gives Menarini the first new branded endocrine therapy for breast cancer in two decades. While a few large companies have come up short in developing oral drugs that degrade estrogen receptors, others are advancing would-be competitors to Orserdu through clinical testing.
Editor’s note: This story has been updated to include comment from Stemline Therapeutics following publication.
