you Please for this for joining which Slide Thanks our story today's Erin and of outline X, us turn morning. an to call. everyone thanks shows
Not bladder both impact States, in also and but only radical cancer there disease a have progression. cancer. a most tremendously high in significant burden, from the with treat the huge unmet cancer United is disease a does is expensive bladder First, need to cystectomy
explain believe favorable mechanism and Second, safety a to favorable both the unique which helps we dual efficacy has Vicinium of action, profile.
we progress forward the we research Third, regulatory our And significant made we complete submission have which on with we our feel XXXX, tremendous a path FDA, we BLA regulatory to recent based believe this recent finally, and market meeting results, a share support market in call, opportunity. later to year. what most will be clear the like in
BCG XX,XXX journey on has Now please $X non-muscle recurrence the turn U.S. invasive the alone. to having you burden initial diagnosed are diagnosis, cancer. as drives can see And bladder It patients slide, that billion important the patients same the which has progression, referred the urologist projected year this this in to Patients that through through roughly which time community-based that urologists. has takes to patient for process, goes early that years. often are usually three for majority to failed, the months the diagnosis every note treatments and diagnostic of by tests, in as been X, face payers Slide for patients continues multiple the after patient bladder journey BCG with on them urologist shows physician the the is means, treating see been and which the diagnosed with patient year, Each a a cancer. often
refer to to intravesical oncologist, able are why they feel a surgeon to medicine easy see if is the ongoing would treatment or the a patient it medical to themselves. urologists with So be reluctant manage an they
studies, Vicinium Based on X. Slide and has a action. preclinical to turn we dual mechanism Please compelling unique believe of
to We healthy leaves of the tolerability cancer cells, safety is and targets differentiates selectively that as Vicinium healthy cell tissue. and generally while generally profile and mechanism alone. cells cancer selective first kills favorable is agents cells it through agents, that both believe direct due which BCG The leaving most VALSTAR, targeting available killing. from such the attack bladder of cancer cells healthy including chemotherapeutic indiscriminately cells. Vicinium alone, Vicinium fact and The
we we death, interesting Vicinium the cell and immune occurs able This efficacy to that antitumor Therefore, Vicinium opinion Because twp what the that recognize results durable adaptive can are second be tumor. results even cells that the been But with and familiar may response, high-prescribing and think These action cell released. our causes and they physicians, neoantigens terms you and an urologists treatment we appears activation of tell this immunogenic it data. dual seeing very killed a tumor and explain I is key mechanism in believe in and and through believe and attack both are T strong mechanism. proliferation, more making have is to neoantigens important which mechanisms DAMPs tell us clinical of T cancer leaders the unique are cell may in choice. both
X. Slide to turn Please
see, profile Vicinium can a differentiated with believe As a you clinical rationale. risk benefit we strong has
the situ months Looking papillary very at those patient for initial and at is FC positive the with patients disease. you see response with three can data, carcinoma in
that for radical competitive ability were Phase payers. and XX% to three our reduce patients of years, data, care see is to benefit are to, quality clinical not come and of of a for for In both only at avoid which You drawn not patients can close response to antitumor this to that to has physicians has to be III impressive important also huge least a in benefit we're patient able time related types. cystectomy durable our any a that. data very it Perhaps life appears costs most cystectomy, a data health which our aware
are and differentiated one Turning versus systemic administered the exposure. age the to dose-related adverse and is This in protects we and FDA local available adverse to no Most body medicines Vicinium highly the which intravesical itself the there that urologists tolerability, is transient, intravenous events. is events reasons pipeline mild Vicinium prescribing systemic lining increase over or bladder believe agents. appear Vicinium and safety therapies. of means and intravesicaly, from prefer like be
being who with so they're are better therapies. investigators are previous In placebo sometimes fact, much treatment think we tolerated they treated hear the than because tolerating they from patients Vicinium that receiving
to invasive opportunity Slide perspective, the would probability profiles similar then this think most a regulatory good bladder of cancer approved know, given as Vicinium very products. the two for It of success know the for for we excluded urologists begs there who regulatory improves branded you We are about X, the in interviews trials Keytruda to randomly efficacy and treatment year. by was a what non-muscle bladder our avoid physicians January choices FDA a question X,XXXX XX% physicians urologists expect to group. were approximately commercial new around of bias. and Turning We we between our this non-muscle this From is clinical These patients. the sign selected, subset treat invasive physicians XX from in were make XX-minute of and who of with conducted the agents. participated cancer
our X, FDA relative the for briefing to profile data submission. Keytruda latest their Slide we to during label, the book last FDA latest Vicinium advisory the the updated we the shared product of profile based BLA committee their interviews, to on Turning as for and part submitted December on based
see very can action. products two you the have of different mechanisms First,
profile research favorable for oncologist. for is Keytruda, safety results we and for limited In and Slide turn only can similar you generally market are are clinical not Vicinium, Vicinium time the projecting a and for promotional Vicinium. medical to by addition, that to reminder only given see data than efficacy are a purposes intravenously X, available cystectomy the Keytruda the intended Vicinium these administered Then and has a any is more impressive purpose. indication on the more results for And for just that data
variety physicians to turning on of scale the asked Slide profiles and of to to for Vicinium So XX, attributes. XX X we a of rank Keytruda a
Vicinium Keytruda. the two to comparable to practices, You can that They into in interest to relative Vicinium current They integrate a their efficacy. greater indicated profile. profiles consider much view better being as physicians see overall easier and have have a Vicinium safety treatment products they believe
XX, of Vicinium for to then when Turning profile and over Keytruda, they between the choose Vicinium time. high-risk them to agents the when cystectomy, branded cancer the XX% non-muscle invasive they choose are choose of given their the choice of the or radical profile Keytruda you ask the branded And XX% roughly about patients, physicians Slide the new agents bladder time.
Slide they reasons Keytruda, On the they explanations. we asked for generally XX, over physicians offered Vicinium prefer four and
rather maintain patients of surgeon and ownership from perspective, journey oncologist patient medical and referring cystectomy. an the factor. or lot important they this bladder of urologists, the for First, loyalty to is a than There between is Keytruda for the prefer radical patient cancer the to a
Vicinium, of comparable better profile Keytruda favorable Second, to profile. they like a safety the demonstrates efficacy which with
to by compelled are data cystectomy for time urologists Vicinium. addition, In strong the
ease they profile mentioned as BCG. Vicinium has Third, of the same of product given the integration, the treatment that profile
patients, can to urologists important is and talk patients means center, physicians. the to For the treatment which this care, same the which they continuity same same to creates of nurse, drive and
large difficult intravenous serious treated of psychologic new go and often be these patient can result means disease, physicians a going medical to oncologists a patients treatment medical feel which to Patients Finally, patient medical effects the referring a center have patients more with a to that will as they experience. a in talk center, negative a oncologist. who building, about to to academic referred
from So of are taking profile pleased with for results up indicates urologists we relative of very we we to These believe Keytruda. with consistent rapid the Vicinium to been what reacted this hearing summarize, to of leaders, the successful highly high-prescribing way profile and the the with Vicinium. growth a have potential launch opinion key are
prescriptions launch. like and with the Slide Turning to of us market end deploy year. we very XX conducting which commercial to well and contract XX estimate were urologists mentioned I category, feel of shortly sales five which this efficient select we in the representatives the we that of by have rounds to roughly before research sales this customer to a focused hope bulk X,XXX organization, we'll We plan the a utilize allow model. to that will at know After urologists, XX,
We these be but decision-making will to digital the have commercial plans not most of only that empower an process, and also help strategies also the have women, scalable and caregivers clear will learned social approach. for and in of are caregivers important efficient inform importance and we whom
conducted On been and commercial rounds surprised pleasantly We've Slide XX, have benchmarks and of pricing common most and the XX payers, over also by spoken both research payer multiple Medicare. we believe the limited reimbursement of is date, likely. to on we restrictions to Vicinium. reimbursement appropriate there that the potential advocacy Based that our by for use for payers to and seem significant research
insightful for an in help commercial plan FDA with and we to such understanding commercial progress the our We mentioned our market stage gated one we And we by pleased required. the gained planning customers and as successful be full as carefully the have the is are if a have have will accepting Vicinium. will BLA the ADCOM, and date. opportunity realize that Overall, I us believe previously, commercial of events spend triggered
I'd the time, like Chad of to for and our Myskiw this hand regulatory forward. At to review a over call path Dr. process
