Lilly enters ripe BTK field with quick FDA nod in mantle cell lymphoma
Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.
The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.
The agency’s green light, disclosed by the 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.
Importantly, for patients to receive Jaypirca, they had to have been on at least two prior therapies, including one of those BTK meds. Labeling for Lilly’s medicine, which comes via the acquisition of Loxo Oncology, includes warnings and precautions for “infections, hemorrhage, cytopenias, atrial fibrillation and flutter, second primary malignancies, and embryo-fetal toxicity.”
Lilly will market the drug, available in the “coming weeks,” for $21,000 per 30 days of therapy at the 200 mg dose, a spokesperson told Endpoints News via email.
FDA based its quick OK on data from 120 patients in a Phase I/II trial. The patients were given 200 mg of the daily drug (known investigationally as pirtobrutinib) until the disease progressed or toxicity became too strong.
Data from that study, dubbed BRUIN, showed 50% of patients responded, with 13% (15 patients) experiencing a complete response. The median duration of response was 8.3 months. A confirmatory study of the drug, needed for a full approval, is enrolling patients.
“Until now, people living with MCL who can no longer be treated with BTK inhibitors have 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 annual confab last month in New Orleans as it looks to pad its case for introducing a reversible version of BTK inhibitors, which entered the market about a decade ago with Imbruvica and then Calquence, both of which came through multibillion-dollar acquisitions of Pharmacyclics and Acerta, respectively. BeiGene entered the market a few years ago and racked up its fourth US nod for Brukinsa last week.
With those drugs on the market for years now, some patients no longer respond to them.
Ahead of ASH last month, Loxo@Lilly CEO Jake Van Naarden told Endpoints the non-covalent drug “allows physicians and patients to continue and exhaust the therapeutic potential of inhibiting BTK as a target when moving onto a slightly different sub-component of this class of medicines.”
Lilly, following suit with the marketed BTK drugs, is testing its drug in patients with other blood cancers, including Waldenström macroglobulinemia, Richter’s transformation, chronic lymphocytic leukemia, small lymphocytic lymphoma and others.
Merck’s non-covalent BTKi, nemtabrutinib, is going into a Phase III trial imminently.