In­cyte nabbed its sec­ond ap­proval from fed­er­al reg­u­la­tors for can­cer drug pemi­ga­tinib, brand­ed as Pe­mazyre — as the po­ten­tial for even more in­di­ca­tions await.

The com­pa­ny, head­ed by CEO Hervé Hop­penot, put out word be­fore the mar­ket opened on Fri­day that the FDA ap­proved Pe­mazyre un­der pri­or­i­ty re­view for re­lapsed or re­frac­to­ry myeloid/lym­phoid neo­plasms (MLNs) with FGFR1 re­arrange­ment. The drug, an FGFR1/2/3 in­hibitor, was orig­i­nal­ly ap­proved back in 2020 for cholan­gio­car­ci­no­ma, al­so known as bile duct can­cer.

In­cyte VP of on­col­o­gy drug de­vel­op­ment Pe­ter Lang­muir told End­points News that the drug had been in the clin­ic around sev­en years, start­ing with clin­i­cal tri­als in 2015. In study­ing cholan­gio­car­ci­no­ma, In­cyte found a sub­set of pa­tients who had mu­ta­tions in the FGFR2 gene, which Pe­mazyre tar­get­ed and help­ing se­cure its even­tu­al ap­proval in the in­di­ca­tion.

“And while we were pur­su­ing the cholan­gio­car­ci­no­ma in­di­ca­tion, we re­al­ized that there was a sub­set of pa­tients with hema­to­log­ic ma­lig­nan­cies that had al­ter­ations in the FGFR1 gene,” Lang­muir not­ed.

That dis­or­der, re­lapsed or re­frac­to­ry MLNs with FGFR1 re­arrange­ment, was once known as 8p11 myelo­pro­lif­er­a­tive syn­drome.

Lang­muir added that while the dis­ease is ex­treme­ly rare (In­cyte said in a state­ment that the dis­ease im­pacts less than 1 in 100,000 peo­ple in the US), it presents in dif­fer­ent ways, such as lym­phoma or leukemia. But all of these pre­sen­ta­tions have what Lang­muir called a “chro­mo­so­mal translo­ca­tion,” where a chro­mo­some breaks and reat­tach­es to dif­fer­ent chro­mo­somes, at spe­cif­ic chro­mo­some 8p11.

The FDA ap­proval was based on da­ta from In­cyte’s Phase II FIGHT-203 study, which test­ed safe­ty and ef­fi­ca­cy in 28 pa­tients with re­lapsed or re­frac­to­ry MLNs with FGFR1 re­arrange­ment in a sin­gle-arm tri­al. How­ev­er, the tri­al con­tin­ued en­roll­ment and ul­ti­mate­ly fin­ished with 47 pa­tients. Lang­muir said that In­cyte will be pre­sent­ing da­ta on the en­tire set of pa­tients at a lat­er date.

Ac­cord­ing to the state­ment, at least 17 pa­tients achieved a com­plete re­sponse across mul­ti­ple co­horts, with the time to re­sponse rang­ing from as short as 44 days to well over a year, in one case. Me­di­an time to re­sponse was 104 days in one sub­set of pa­tients.

The most com­mon ad­verse re­ac­tions in pa­tients, In­cyte said, in­clud­ed hy­per­phos­phatemia (ab­nor­mal­ly high serum phos­phate lev­els), nail tox­i­c­i­ty, alope­cia and stom­ati­tis.

As for fu­ture in­di­ca­tions, Lang­muir added that Phase II stud­ies are on­go­ing and test­ing Pe­mazyre in glioblas­toma and lung can­cer. How­ev­er, In­cyte will wait on the da­ta read­outs be­fore con­firm­ing that those in­di­ca­tions are what the com­pa­ny will pur­sue next.

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.