The mul­ti­ple myelo­ma ri­val­ry be­tween Sanofi and J&J con­tin­ued Wednes­day evening, with the French drug­mak­er’s Sar­clisa tak­ing home a new ap­proval in the in­di­ca­tion.

US reg­u­la­tors OK’d the drug in com­bi­na­tion with Am­gen’s Kypro­lis and the steroid dex­am­etha­sone for adults with re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma who have re­ceived be­tween one and three pre­vi­ous lines of treat­ment. It’s the sec­ond ap­proval for Sar­clisa, hav­ing pre­vi­ous­ly won a green light in March 2020 as a third-line treat­ment for the dis­ease.

And with the ex­pand­ed la­bel now in hand, Sar­clisa is once again tak­ing aim at J&J’s mar­ket lead­ing Darza­lex.

First ap­proved in 2015 for treat­ment-re­sis­tant mul­ti­ple myelo­ma, Darza­lex quick­ly be­came a block­buster and gen­er­at­ed $1.4 bil­lion of sales in its first year. It has since steadi­ly ex­pand­ed its mar­ket, most re­cent­ly earn­ing an OK last Au­gust with the same cock­tail and same in­di­ca­tion as Sar­clisa did Wednes­day.

Last year, Darza­lex tal­lied its best year yet with near­ly $4.2 bil­lion in sales across all in­di­ca­tions, ac­cord­ing to J&J and de­vel­op­er Gen­mab.

Sar­clisa, mean­while, is still find­ing its foot­ing in the mar­ket, hav­ing gained its first ap­proval a mere nine days be­fore the WHO de­clared a glob­al pan­dem­ic for Covid-19. The drug pulled in just over $50 mil­lion in 2020 sales. But the drug still marked a mile­stone for Sanofi, as Sar­clisa was the French phar­ma’s first in-house can­cer ap­proval since Jev­tana in 2010.

Both drugs are mon­o­clon­al an­ti­bod­ies that fo­cus on CD38, which is high­ly ex­pressed on mul­ti­ple myelo­ma cells, but func­tion slight­ly dif­fer­ent­ly. Darza­lex locks on to the CD38 mol­e­cule, while Sar­clisa is en­gi­neered to tar­get a spe­cif­ic por­tion of the anti­gen found on the pro­tein.

Wednes­day’s Sar­clisa OK came on the ba­sis of a 302-pa­tient Phase III tri­al, which showed the com­bo re­duced the risk of dis­ease pro­gres­sion or death by 45% com­pared to the Kypro­lis/dex­am­etha­sone stan­dard of care. That clocked in at a p-val­ue of p=0.0032.

Though cross-tri­al com­par­isons are nev­er a per­fect sci­ence, that fig­ure came in nu­mer­i­cal­ly high­er than the foun­da­tion for Darza­lex’s ap­proval in the same in­di­ca­tion. The Darza­lex com­bo with Kypro­lis and dex­am­etha­sone on­ly re­duced that risk by 37%.

Sar­clisa did miss on a sec­ondary end­point, how­ev­er, fail­ing to reg­is­ter a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence in over­all re­sponse rate. Those num­bers re­mained sim­i­lar for each arm: 86.6% for the Sar­clisa com­bo ver­sus 82.9% for stan­dard of care.

Go­ing for­ward, Sanofi is ex­pect­ing a de­ci­sion in this in­di­ca­tion from the EU “in the com­ing months,” and re­ceived a pos­i­tive CHMP opin­ion in Feb­ru­ary. Re­searchers con­tin­ue to look at Sar­clisa across the mul­ti­ple myelo­ma land­scape as well, as the phar­ma says it’s en­gaged in sev­er­al on­go­ing Phase III tri­als. Sanofi is al­so in­ves­ti­gat­ing the drug for the treat­ment of oth­er hema­to­log­ic ma­lig­nan­cies and sol­id tu­mors.

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.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

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.