Ju­ly 12 FDA pan­el re­view looms as a wa­ter­shed mo­ment in No­var­tis’ cam­paign to win an his­toric new drug OK

If you have any in­ter­est in the CAR-T field, mark down Wednes­day, Ju­ly 12 as a red let­ter day.

The FDA post­ed a note on Tues­day say­ing that its group of out­side can­cer ex­perts will gath­er that day to dis­cuss the phar­ma gi­ant’s ap­pli­ca­tion and vote on whether No­var­tis $NVS should get a mar­ket­ing ap­proval for its lead­ing CAR-T CTL019 (ti­s­agen­le­cleu­cel-T) as a new treat­ment for re­lapsed and re­frac­to­ry pe­di­atric B-cell acute lym­phoblas­tic leukemia. And on Mon­day pre­ced­ing the pan­el re­view the FDA will be ex­pect­ed to de­liv­er its in­ter­nal re­view of the ther­a­py, which will fur­ther tip its hand on what reg­u­la­tors are think­ing about the da­ta for a drug award­ed its break­through ther­a­py des­ig­na­tion.

The lat­est twist in this close­ly-watched saga comes a lit­tle more than two months since No­var­tis won a pri­or­i­ty re­view for its po­ten­tial­ly rev­o­lu­tion­ary CAR-T, which ex­tracts T cells from pa­tients, reengi­neers them and in­fus­es them by the mil­lions to swarm can­cer cells. The pri­or­i­ty re­view lopped two months off the re­view process, hit­ting fast for­ward on the agency’s call.

Right on its heels, two months be­hind in the process, is Kite Phar­ma $KITE with its ap­pli­ca­tion to mar­ket KTE-C19 (axi­cab­ta­gene ciloleu­cel) for non-Hodgkin lym­phoma, al­so new­ly of­fered a pri­or­i­ty re­view of its own.

No­var­tis and Kite have both of­fered some com­pelling da­ta for these CAR-Ts. And while they are not cur­rent­ly go­ing head-to-head on the same in­di­ca­tion, No­var­tis will be of­fer­ing what could be a di­rect chal­lenge when it rolls out its JULI­ET da­ta mid-week.

I’ll be fol­low­ing that too.

In ad­di­tion to ef­fi­ca­cy, you can ex­pect plen­ty of dis­cus­sion about the safe­ty pro­file of this drug. Un­like its ri­vals, No­var­tis and its part­ners at the Uni­ver­si­ty of Penn­syl­va­nia have large­ly avoid­ed the safe­ty crises that af­flict­ed Juno $JUNO and blew up its lead ther­a­py. Kite al­so has had to deal with the death of one pa­tient from a case of cere­bral ede­ma while cy­tokine re­lease syn­drome con­tin­ues to hov­er as clear threat that physi­cians have to guard against in many cas­es.

If ap­proved, No­var­tis will al­so be ex­pect­ed to com­pete ef­fec­tive­ly on the man­u­fac­tur­ing side, work­ing to re­duce the time it takes to get this drug from pa­tients, pre­pare it and then get it back in­to the vein.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Jake Van Naarden, Loxo@Lilly CEO

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.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.