In crowd­ed prostate can­cer mar­ket, Pfiz­er's Xtan­di notch­es third ap­proval for use in ear­li­er stage of dis­ease

Pfiz­er’s en­trenched an­dro­gen re­cep­tor in­hibitor Xtan­di has se­cured its third prostate can­cer ap­proval in a mar­ket flush with ri­vals.

On Mon­day, Pfiz­er and part­ner Astel­las an­nounced Xtan­di had scored FDA ap­proval in pa­tients with metasta­t­ic cas­tra­tion (or hor­mone)-sen­si­tive prostate can­cer (mC­SPC). It’s a form of prostate can­cer that has spread to oth­er parts of the body but still re­sponds to a med­ical or sur­gi­cal treat­ment that low­ers testos­terone — af­fect­ing rough­ly 40,000 men in the Unit­ed States cur­rent­ly. Xtan­di is now the on­ly oral FDA-ap­proved ther­a­py in three dis­tinct types of ad­vanced prostate can­cer, the com­pa­nies said.

Xtan­di in com­bi­na­tion with stan­dard an­dro­gen de­pri­va­tion ther­a­py (ADT) was test­ed against ADT plus place­bo in the ARCH­ES tri­al in 1,150 pa­tients with metasta­t­ic hor­mone (or cas­tra­tion) sen­si­tive prostate can­cer.

Da­ta showed the Xtan­di com­bi­na­tion re­duced the risk of ra­di­ograph­ic pro­gres­sion or death by 61% ver­sus place­bo plus ADT (con­fi­dence in­ter­val: 0.30-0.50; p<0.0001) — over­all sur­vival da­ta were not ma­ture at the time of analy­sis.

In the first nine months of 2019, the drug gen­er­at­ed $594 mil­lion in glob­al sales. An­ti-an­dro­gens drugs such as J&J’s Zyti­ga and Pfiz­er’s Xtan­di were first ap­proved in metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer (mCR­PC) in 2011 and 2012 re­spec­tive­ly. Since then, this class of drugs has al­so shown to be ef­fec­tive in ear­li­er-dis­ease set­tings such as non-metasta­t­ic CR­PC and metasta­t­ic hor­mone-sen­si­tive prostate can­cer (mH­SPC).

In a note re­flect­ing dis­cus­sions by a pan­el of prostate can­cer ex­perts in Sep­tem­ber, Cowen an­a­lysts cit­ed a pan­elist that in­di­cat­ed that the sev­er­al an­ti-an­dro­gens on the mar­ket are on some­what “equal foot­ing” in the mH­SPC set­ting with sim­i­lar clin­i­cal da­ta. “Pa­tients in the U.S. pre­fer oral hor­mon­al agents over al­ter­na­tive chemother­a­py, so our ex­pert be­lieves Zyti­ga and Xtan­di could both hold sub­stan­tial mar­ket share in mH­SPC,” they wrote.

Prostate can­cer is the sec­ond most com­mon­ly di­ag­nosed ma­lig­nan­cy in men glob­al­ly, and treat­ment op­tions in­clude surgery, ra­di­a­tion treat­ment and ther­a­py us­ing hor­mone-re­cep­tor an­tag­o­nists. How­ev­er, in near­ly every case, the can­cer grows re­sis­tant to con­ven­tion­al hor­mone ther­a­py. Cas­tra­tion-re­sis­tant prostate can­cer (CR­PC) is an ad­vanced form of the dis­ease and is char­ac­ter­ized by per­sis­tent, high-lev­el an­dro­gen re­cep­tor (AR) func­tion and re­sis­tance to con­ven­tion­al an­ti-an­dro­gens.

Ear­li­er this year, Bay­er and Finnish part­ner Ori­on’s AR in­hibitor Nube­qa was ap­proved for pa­tients with cas­tra­tion-re­sis­tant prostate can­cer that has not spread to oth­er parts of the body (nm­CR­PC). Mean­while, PARP and PD-(L)1 agents are al­so be­ing test­ed for use in prostate can­cer.

So­cial im­age: Pfiz­er, Jeff Ru­mens

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This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Bernie Sanders, AP Images

Bernie Sanders goes af­ter Bio­Mar­in's shot at a record drug price, threat­en­ing to break the patent

Bioregnum Opinion Column by John Carroll

Last week at JP Morgan, BioMarin CEO JJ Bienaimé laid out his thoughts on pricing the leading gene therapy for hemophilia A at $2 million to $3 million a shot. Payers would support that, he said, putting the biotech on track to launching a treatment that could top the price of Novartis’s $2.1 million gene therapy for spinal muscular atrophy.

And with that, he earned some high-level attention from a would-be president of the United States.

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Hal Barron and Emma Walmsley, GSK

GSK’s ‘break­through’ BC­MA can­cer drug gets a pri­or­i­ty re­view — and a big win for the on­col­o­gy R&D team

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Who are the young bio­phar­ma lead­ers shap­ing the in­dus­try? Nom­i­nate them for End­points' spe­cial re­port

Two years ago, when we did our first Endpoints 20-under-40, we profiled a set of up-and-comers who promised to help reshape the industry as we know it. Now we’re back and once again looking for the top 20 biopharma professionals under the age of 40. We’ll be profiling folks who have accomplished a lot at a young age but seem on the verge of accomplishing so much more.

And we need your help.

John Oyler, Endpoints

BeiGene lines up its first shot at crack­ing the megablock­buster PD-1 mar­ket for lung can­cer. But can they over­come un­der­dog sta­tus?

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The China-based biotech $BGNE run by CEO John Oyler posted positive top-line progression-free survival results for their pivotal Chinese study on their PD-1 antibody tislelizumab combined with chemo for squamous non-small cell lung cancer in frontline cases. Squamous NSCLC accounts for about 30% of the overall lung cancer market.

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Eric Halioua (PDC*line Pharma via Andrew Lloyd & Associates)

French-Bel­gian biotech banks €20M to break ground in blood-splat­tered field of ther­a­peu­tic can­cer vac­cines

About a decade ago, the ill-fated therapeutic cancer vaccine — Provenge — was approved, eventually bankrupting its developer Dendreon. Since then a number of drugmakers have seen their cancer vaccine efforts splutter and fizzle, although the emergence of immunotherapies — checkpoint inhibitors and CAR-T drugs — offered a glimmer of hope in resuscitating the field. Banking on that promise is PDC*line Pharma, which secured a €20 million injection on Wednesday.

David Ricks (Eli Lilly via YouTube)

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Anchored by three of the state’s top research universities, RTP is also home to some of the world’s top contract research organizations as well as a growing group of biopharma companies.

UP­DAT­ED: FDA hands off its lat­est whirl­wind drug OK as Hori­zon hus­tles would-be block­buster to the mar­ket

The FDA isn’t letting its foot off the gas pedal just because it’s January.

The agency came through with an approval for Horizon Therapeutics’ $HZNP new thyroid eye drug Tepezza (teprotumumab), close to two months ahead of the PDUFA date — which was already set early in the year due to a priority review designation. But that sort of thing is becoming routine at the agency, especially if it has a designated “breakthrough therapy” on its hands.

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