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

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.