Ac­cel­er­ated ac­tion to re­duce pre­ma­ture mor­tal­ity from can­cer

Grow­ing in­ci­dences of tar­get dis­ease such as lung can­cer, breast can­cer, cer­vi­cal can­cer, etc. across the globe are driv­ing the global can­cer drugs mar­ket. Other ma­jor driv­ing fac­tors are in­creas­ing re­search and de­vel­op­ment on bi­o­log­i­cal and tar­geted drug

BioSpectrum (Asia) - - Front Page - (With in­puts from Priyanka Bajpai)

On Jan­uary 12, the US Food and Drug Ad­min­is­tra­tion (FDA) has granted reg­u­lar ap­proval for two anti-can­cer drugs. The first one is for ola­parib tablets (Lyn­parza, As­traZeneca Phar­ma­ceu­ti­cals LP), a poly (ADP-ri­bose) poly­merase (PARP) in­hibitor, for the treat­ment of pa­tients with dele­te­ri­ous or sus­pected dele­te­ri­ous germline BRCA-mu­tated (gBRCAm), HER2-neg­a­tive metastatic breast can­cer who have been treated with chemo­ther­apy ei­ther in the neoad­ju­vant, ad­ju­vant, or metastatic set­ting.

The other anti-can­cer drug that got the ap­proval is afa­tinib (Gilotrif, Boehringer In­gel­heim Phar­ma­ceu­ti­cal, Inc.) for a broad­ened in­di­ca­tion in first-line treat­ment of pa­tients with metastatic non-small cell lung can­cer (NSCLC) whose tu­mors have non-re­sis­tant epi­der­mal growth fac­tor re­cep­tor (EGFR) mu­ta­tions as de­tected by an FDA-ap­proved test.

Be­sides there is one more treat­ment that got ap­proval from FDA on Jan­uary 26 for lutetium Lu 177 dotatate (LUTATHERA, Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions USA, Inc.) a ra­di­o­la­beled so­mato­statin ana­log, for the treat­ment of so­mato­statin re­cep­tor­pos­i­tive gas­troen­teropan­cre­atic neu­roen­docrine tu­mors (GEPNETs), in­clud­ing foregut, midgut, and hindgut neu­roen­docrine tu­mors in adults. In just 30 days, from Jan­uary 1, 2018 the FDA has given three ap­provals re­lated to can­cer treat­ments.

Since 2011, the FDA has given more than 10 ap­provals each year for anti-can­cer treat­ments. The num­ber of ap­provals has in­creased in last 15 years from 26 dur­ing 2003-07 pe­riod, to 70 in 2013-17. In the last 25 years the fed­eral agency in US, re­spon­si­ble for pro­tect­ing and pro­mot­ing pub­lic health, has

ap­proved more than 200 anti-can­cer drugs. Such favourable reg­u­la­tory frame­work is ex­pected to boost over­all prod­uct de­mand in the fu­ture.

The mar­ket for an­ti­cancer treat­ments is a boom­ing busi­ness for the phar­ma­ceu­ti­cal in­dus­try. Nearly all of the ma­jor phar­ma­ceu­ti­cal com­pa­nies are ei­ther cur­rently man­u­fac­tur­ing anti-can­cer drugs or have anti-can­cer drugs/ treat­ments in their pipe­line as po­ten­tial med­i­ca­tions in the com­ing years. Can­cer af­fects mil­lions of peo­ple each year, and as the world pop­u­la­tion con­tin­ues to grow, the rate of new can­cer cases will likely grow too. Re­cent de­vel­op­ments in the phar­ma­ceu­ti­cal in­dus­try have made can­cer cur­able in many cases. Many of the newer med­i­ca­tions are geared to­wards very spe­cific kinds of can­cer, charg­ing pre­mium prices and fac­ing lit­tle com­pe­ti­tion. And be­cause bi­o­logic treat­ments do not have the same kind of generic com­pe­ti­tion as chem­i­cal drugs, they have a longer shelf-life in terms of patent pro­tec­tion. This means the drug man­u­fac­tur­ers can con­tinue to charge what­ever prices they see fit since their drugs have no generic equiv­a­lents.

The phar­ma­ceu­ti­cal in­dus­try’s 20 top-selling can­cer drugs gen­er­ate an­nual sales over $50 bil­lion world­wide. Roche’s Ri­tuxan, Avastin, and Her­ceptin lead the pack, with $21 bil­lion in sales for th­ese three drugs alone. Roche’s top on­col­ogy line rep­re­sented about 40 per cent of the top 20 in com­bined sales, ac­cord­ing to a Oc­to­ber 2017 re­port by the­bal­ance. com. There is an in­creas­ing de­mand world­wide for on­col­ogy med­i­ca­tions, so phar­ma­ceu­ti­cal com­pa­nies are see­ing sig­nif­i­cant growth out­side of their usual mar­kets in the United States and Europe.

Ris­ing health­care ex­pen­di­tures in Asian coun­tries like China and Ja­pan make med­i­ca­tions more ac­ces­si­ble. An ex­pand­ing mid­dle class in In­dia, par­tially due to the in­flux of phar­ma­ceu­ti­cal com­pa­nies out­sourc­ing man­u­fac­tur­ing to In­dian fac­to­ries, makes more ex­pen­sive med­i­cal care pos­si­ble for those who can af­ford it. Ac­cord­ing to, the global on­col­ogy mar­ket is ex­pected to grow at a rate of 7.5 per cent with top-ten com­pa­nies ac­count­ing for more than one-third of the mar­ket share. Roche tops the list with three drugs in the high rank­ings ac­count­ing for nearly 45 per cent of the rev­enues. Cel­gene’s Revlimid is the best-selling drug also show­ing a 20 per cent growth rate from 2015. In­ter­est­ingly, the rev­enue gen­er­ated from the top 10 on­col­ogy drugs in 2016 in­creased by 13 per cent when com­pared with the top 10 list of 2015, thereby re­veal­ing nu­mer­ous mar­ket op­por­tu­ni­ties.

Ac­cord­ing to Zion Mar­ket Re­search re­port, global can­cer drugs mar­ket was val­ued at ap­prox­i­mately $ 112.90 bil­lion in 2015 and is ex­pected to gen­er­ate rev­enue of around $ 161.30 bil­lion by end of 2021, grow­ing at a CAGR of around 7.4 per cent be­tween 2016 and 2021. North Amer­ica is an­tic­i­pated to re­main the lead­ing re­gion. De­mand for can­cer drugs was high­est in North Amer­ica es­pe­cially in the US. Hence, Asia Pacific is ex­pected to be the mod­er­ate grow­ing re­gion in can­cer drugs mar­ket. More­over, the Mid­dle East and Africa and Latin Amer­ica are also ex­pected to show mod­er­ate growth for this mar­ket in the years to come.

Global can­cer drugs mar­ket is pri­mar­ily driven by grow­ing in­ci­dences of tar­get dis­ease such as lung can­cer, breast can­cer, cer­vi­cal can­cer, etc. across the globe. Other ma­jor driv­ing fac­tors are in­creas­ing re­search and de­vel­op­ment on bi­o­log­i­cal and tar­geted drug ther­a­pies for the treat­ment of can­cer cou­pled with the ex­pi­ra­tion of patents. How­ever, the high price of drug de­vel­op­ment and strin­gent reg­u­la­tory poli­cies cou­pled with the pos­si­bil­ity of fail­ure are the ma­jor re­straints

that may limit the growth of the mar­ket. None­the­less in­creas­ing fo­cus on per­son­al­ized medicine along with huge in­vest­ment in anti-can­cer drugs re­search across the globe is likely to dis­close the new av­enues for can­cer drugs mar­ket in the near fu­ture.

The anti-can­cer drugs mar­ket is seg­mented on the ba­sis of the dif­fer­ent ther­a­peu­tic seg­ment in­clud­ing im­munother­apy, tar­geted ther­apy, chemo­ther­apy, hor­mone ther­apy and oth­ers. Re­cent progress in bi­o­log­i­cal ther­a­pies has widened the scale of ther­a­peu­tic tar­gets for treat­ment of can­cer with the iden­ti­fi­ca­tion of tu­mor cell spe­cific genes. Im­munother­a­pies/ bi­o­log­ics are emerg­ing as po­ten­tial ther­a­pies to find the per­ma­nent cure for var­i­ous can­cer types. Amongst var­i­ous bi­o­log­ics, drugs based on mon­o­clonal an­ti­bod­ies (mAbs) have gained sig­nif­i­cant at­ten­tion in re­cent years due to their high ef­fi­cacy fur­ther pro­pel­ling the growth of on­col­ogy/ can­cer drugs mar­ket.

Breast can­cer, blood can­cer, gas­troin­testi­nal can­cer, prostate can­cer, skin can­cer, lung can­cer and oth­ers are the key com­po­nents of the global can­cer drugs mar­ket. The blood can­cer seg­ment dom­i­nate the mar­ket in terms of rev­enue.

A ma­jor­ity of the on­col­ogy drug man­u­fac­tur­ers have adopted col­lab­o­ra­tion and ac­qui­si­tion as key de­vel­op­men­tal strate­gies to achieve a com­pet­i­tive edge. More­over, com­pa­nies are also form­ing strate­gic al­liances to ac­cel­er­ate the process of clin­i­cal tri­als. Th­ese strate­gies have proved to be ef­fec­tive in help­ing key mar­ket play­ers re­tain their lead­ing po­si­tions in the global on­col­ogy drugs mar­ket.

WHO ini­tia­tives

Can­cer is a lead­ing cause of death world­wide, ac­count­ing for 8.8 mil­lion deaths in 2015. And nearly ev­ery fam­ily in the world is touched by can­cer, which is now re­spon­si­ble for al­most one in six deaths glob­ally. Be­tween 30–50 per cent of can­cers can cur­rently be pre­vented by avoid­ing risk fac­tors and im­ple­ment­ing ex­ist­ing ev­i­dence-based preven­tion strate­gies. The can­cer bur­den can also be re­duced through early de­tec­tion of can­cer and man­age­ment of pa­tients who

de­velop can­cer. Many can­cers have a high chance of cure if di­ag­nosed early and treated ad­e­quately.

To raise aware­ness of can­cer and to en­cour­age its preven­tion, de­tec­tion, and treat­ment, World Can­cer Day has been ob­served on Fe­bru­ary 4 each year. This in­ter­na­tional day was founded by the Union for In­ter­na­tional Can­cer Con­trol (UICC) to sup­port the goals of the World Can­cer Dec­la­ra­tion, writ­ten in 2008. The pri­mary goal of the World Can­cer Day is to sig­nif­i­cantly re­duce ill­ness and death caused by can­cer by 2020.

Founded in 1933 and based in Geneva, Switzer­land, UICC (pre­vi­ously named In­ter­na­tional Union Against Can­cer) has a mem­ber­ship of over 800 or­gan­i­sa­tions across 155 coun­tries, and fea­tures the world’s ma­jor can­cer so­ci­eties, min­istries of health, re­search in­sti­tutes and pa­tient groups. UICC part­ners with its mem­bers, key part­ners, the World Health Or­ga­ni­za­tion (WHO), World Eco­nomic Fo­rum and oth­ers, to tackle can­cer on a global scale.

On World Can­cer Day WHO high­lights that can­cer no longer needs to be a death sen­tence, as the ca­pac­ity ex­ists to re­duce its bur­den and im­prove the sur­vival and qual­ity of life of peo­ple liv­ing with the dis­ease. “All coun­tries can do more to pre­vent and treat can­cer,” notes Dr Etienne Krug, WHO Direc­tor for the Depart­ment for Man­age­ment of Non-com­mu­ni­ca­ble Dis­eases, Dis­abil­ity, Vi­o­lence and In­jury Preven­tion. “We know the main causes. Act­ing upon them will avoid that many cases oc­cur in the first place. By strength­en­ing the health sys­tem re­sponse, we can also en­sure ear­lier di­ag­no­sis and bet­ter ac­cess to af­ford­able treat­ment by qual­i­fied per­son­nel, thereby sav­ing mil­lions of lives.”

In May 2017, Mem­ber States came to­gether around pri­or­ity ac­tions to en­sure can­cer care for all. World Health As­sem­bly res­o­lu­tion WHA A70/A/CONF./9 “Can­cer preven­tion and con­trol in the con­text of an in­te­grated ap­proach” lays out a clear road map to re­al­ize the po­ten­tial for preven­tion, early di­ag­no­sis, prompt treat­ment and pal­lia­tive care for peo­ple with can­cer. Since adop­tion of the res­o­lu­tion, Mem­ber States are tak­ing ac­tion on its rec­om­men­da­tions.

Govern­ments are en­act­ing ev­i­dence-based riskre­duc­ing strate­gies such as im­pos­ing higher taxes on tobacco and al­co­hol, pro­mot­ing healthy di­ets and phys­i­cal ac­tiv­ity, and ad­vo­cat­ing for ac­cess to HPV vac­ci­na­tion. Ap­prox­i­mately 30-50% of can­cers can be pre­vented if th­ese poli­cies are max­i­mally im­ple­mented.

Yet, ac­cel­er­ated ac­tion is needed if global tar­gets of re­duc­ing pre­ma­ture mor­tal­ity from can­cer and en­sur­ing uni­ver­sal health cov­er­age are to be achieved. Treat­ing can­cer in its early stages is key. To­day, many cases of can­cer are di­ag­nosed too late – this means they are harder to treat suc­cess­fully. A re­newed em­pha­sis on strength­en­ing health sys­tems is needed to en­sure early di­ag­no­sis and ac­ces­si­ble, high-qual­ity care for pa­tients. This will re­sult in higher can­cer sur­vival rates.

De­tect­ing can­cer early also greatly re­duces can­cer’s fi­nan­cial im­pact: not only is the cost of treat­ment much less in the early stages of can­cer, but peo­ple can also con­tinue to work and sup­port their fam­i­lies if they can ac­cess ef­fec­tive treat­ment in time.

Narayan Kulka­rni narayan.kulka­rni@mmac­

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