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.

The EMA released updated recommendations today for the use of JAK inhibitors (JAKi) after reviewing data from several clinical trials that showed increased incidents of issues in certain patients who have rheumatoid arthritis and other risk factors.

The EMA noted malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality in some patients.

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

A Massachusetts federal judge on Wednesday dismissed a class action lawsuit filed by investors against Biogen and several of its current and former executives over the company’s failed Alzheimer’s drug, Aduhelm (aducanumab).

The investors argued that Biogen’s contact with the FDA was unlawful and that the company made 25 false and misleading statements, including statements about the rollout and price of the drug.

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.