Eli Lilly succeeded in its bid to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors on the market, pushing it ahead of rival Merck.
The FDA gave an expedited nod to Lilly’s daily oral drug, which will be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.
The agency’s green light, disclosed by Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.
It is important to note that for patients to receive Jaypirca, they had to have had at least two previous treatments, including one of these BTK drugs. Lilly’s drug labeling, which comes from the Loxo Oncology acquisition, includes warnings and precautions for «infections, hemorrhages, cytopenias, atrial fibrillation and flutter, second primary cancers and embryo toxicity.» -fetal».
Lilly will market the drug, available in the «coming weeks,» for $21,000 per 30-day course at a 200mg dose, a spokesperson said. Terminal News by email.
The FDA based its rapid approval on data from 120 patients in a phase I/II trial. Patients were given 200 mg of the daily drug (known as pirtobrutinib) until the disease progressed or the toxicity became too strong.
Data from this study, dubbed BRUIN, showed that 50% of patients responded, with 13% (15 patients) achieving a complete response. The median duration of response was 8.3 months. A confirmatory study of the drug, required for full approval, is enrolling patients.
«Until now, people living with MCL who can no longer be treated with BTK inhibitors had few alternatives,» said Meghan Gutierrez, CEO of the Lymphoma Research Foundation, in a statement.
Lilly presented more data on the drug at the American Society of Hematology’s annual conference last month in New Orleans as it seeks to build its case for the introduction of a reversible version of the inhibitors. BTK, which entered the market about a decade ago with Imbruvica and then Calquence, both of which resulted from multi-billion dollar acquisitions of Pharmacyclics and Acerta, respectively. BeiGene entered the market a few years ago and landed its fourth US nod for Brukinsa last week.
With these drugs on the market for years, some patients no longer respond to them.
Ahead of ASH last month, Loxo@Lilly CEO Jake Van Naarden told Endpoints that the non-covalent drug «allows physicians and patients to continue and exhaust the therapeutic potential of BTK inhibition as a than target when switching to a slightly different subcomponent of that class of drugs.”
Lilly, following in the footsteps of marketed BTK drugs, is testing its drug in patients with other blood cancers, including Waldenstrom’s macroglobulinemia, Richter’s transformation, chronic lymphocytic leukemia, small lymphocytic lymphoma and others.
Merck’s non-covalent BTKi, nemtabrutinib, will soon enter a phase III trial.