One of the key ways in which No­var­tis CEO Vas Narasimhan hopes to stave off gener­ic com­pe­ti­tion took a gi­ant leap for­ward Wednes­day af­ter­noon.

The FDA ap­proved Lu-PS­MA-617, No­var­tis’ ra­di­oli­gand pro­gram ac­quired in the $2.1 bil­lion buy­out of En­do­cyte back in 2018, to treat PS­MA-pos­i­tive metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer. No­var­tis will brand the drug as Plu­vic­to, and a spokesper­son told End­points News that the drug’s whole­sale ac­qui­si­tion cost will be set at $42,500 per dose.

Pa­tients will be capped at six dos­es ad­min­is­tered six weeks apart, lead­ing to a po­ten­tial max­i­mum cost per pa­tient of $255,000, the spokesper­son added.

Narasimhan tout­ed Lu-PS­MA-617 dur­ing No­var­tis’ R&D day in De­cem­ber as a po­ten­tial big sales dri­ver, putting the drug un­der its “high ev­i­dence” um­brel­la among oth­er mid- and late-stage as­sets. The de­ci­sion proved no­table as No­var­tis is an­tic­i­pat­ing gener­ics will cut in­to sales of its pre­vi­ous­ly ap­proved drugs by $9 bil­lion over the next five years.

Reg­u­la­tors ap­proved the drug based on Phase III da­ta No­var­tis pre­sent­ed at AS­CO last June, which showed the drug re­duced pa­tients’ risk of death by 38% on top of stan­dard of care. Lu-PS­MA-617 al­so post­ed a 60% re­duc­tion in tu­mor size or death com­pared to the stan­dard on its own, and hit on every oth­er sec­ondary mea­sure in the Phase III study.

No­var­tis had pre­vi­ous­ly de­scribed the da­ta as “ground­break­ing” and won break­through ther­a­py des­ig­na­tion for the drug short­ly af­ter AS­CO. The com­pa­ny said at the end of Sep­tem­ber that the drug had been ac­cept­ed for pri­or­i­ty re­view, putting Wednes­day’s ap­proval right around the six-month mark.

Su­sanne Schaf­fert

In an in­ter­view with End­points last month ahead of the de­ci­sion, No­var­tis On­col­o­gy pres­i­dent Su­sanne Schaf­fert said about 80% of those with prostate can­cer see their tu­mors be­come metasta­t­ic, with a five-year sur­vival rate of rough­ly 30%. That makes the med­ical need — and the po­ten­tial com­mer­cial op­por­tu­ni­ty — sub­stan­tial.

Ad­di­tion­al­ly, Schaf­fert ad­dressed some of the safe­ty con­cerns that come along with ra­dio­phar­ma drugs, not­ing the com­pa­ny’s ex­pe­ri­ence with Lu­tathera will help in­form de­ci­sions with Plu­vic­to.  The lig­and used with Lu­tathera has a half-life of on­ly 72 hours, while the one used with Plu­vic­to lasts about five days.

The short lengths could help ad­verse events sub­side af­ter on­ly a short while, but al­so means clin­i­cians will have to dose pa­tients quick­ly af­ter re­ceiv­ing the drugs.

“We, as No­var­tis, may have on­ly 24 hours to de­liv­er it to still de­liv­er enough ra­dioac­tiv­i­ty to pa­tients,” Schaf­fert told End­points. “And that, of course, is some­thing you have to care­ful­ly set up, you need to be able to get this prod­uct to the pa­tient. And it’s in­di­vid­ual, it’s not ware­house, it’s re­al­ly in­di­vid­ual by or­der to the pa­tient.”

No­var­tis has been at the fore­front of the ra­dio­phar­ma push, ac­quir­ing the French com­pa­ny Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions in late Oc­to­ber 2017 for $3.9 bil­lion that gave it Lu­tathera and a ra­dio­phar­ma plat­form. The buy­out was fol­lowed by the En­do­cyte deal about a year lat­er, and VC and more Big Phar­ma cash has poured in­to the space in the years since.

Ver­sant and ven­Bio teamed up in 2020 to back a $45M launch round for San Diego biotech Rayze­Bio, and Bay­er bought out two tiny com­pa­nies in June in its own for­ay in­to the space.

This ar­ti­cle has been up­dat­ed to clar­i­fy the max­i­mum cost per pa­tient and the half-lives of No­var­tis’ re­spec­tive ra­dio­phar­ma­ceu­ti­cal drugs. 

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”