In the 10th ap­proval since its 2013 launch, J&J’s can­cer drug Im­bru­vi­ca has se­cured the FDA nod in com­bi­na­tion with Roche’s obin­u­tuzum­ab in adults with the most com­mon form of leukemia — mark­ing the first non-chemother­a­py reg­i­men for treat­ment-naïve pa­tients with chron­ic lym­pho­cyt­ic leukemia/small lym­pho­cyt­ic lym­phoma (CLL/SLL).

The ap­proval ex­pands the use of Im­bru­vi­ca — which is al­so sold by Ab­b­Vie — in front­line CLL/SLL be­yond its use as a monother­a­py. The drug it­self gen­er­at­ed sales of about $2.6 bil­lion last year. The block­buster treat­ment has seen steady growth in mar­ket share, lead­ing the Unit­ed States in first and sec­ond line CLL as well as sec­ond-line man­tle cell lym­phoma (MCL), and is the to­tal pa­tient share leader in Walden­strom macroglob­u­line­mia (WM) — a type of non-Hodgkin lym­phoma — ac­cord­ing to Cred­it Su­isse.

The ap­proval of Im­bru­vi­ca in com­bi­na­tion with CD20 an­ti­body obin­u­tuzum­ab was based on the Phase III iL­LU­MI­NATE study. The 212-pa­tient open-la­bel tri­al test­ed Im­briv­i­ca+obin­u­tuzum­ab ver­sus obin­u­tuzum­ab+chlo­ram­bu­cil (a chemother­a­py treat­ment). At a me­di­an fol­low-up of about 31 months, the Im­bru­vi­ca reg­i­men helped pa­tients live longer with­out their dis­ease pro­gress­ing com­pared to the chemother­a­py reg­i­men (19 months), with 77% re­duc­tion in risk of pro­gres­sion or death, J&J said.

CLL is a com­mon type of can­cer that can de­vel­op from cells in the bone mar­row that lat­er ma­ture in­to cer­tain white blood cells, and ac­counts for about one-quar­ter of the new cas­es of leukemia, ac­cord­ing to the Amer­i­can Can­cer So­ci­ety, which es­ti­mates about 20,720 new CLL cas­es will oc­cur in 2019. SLL is a slow-grow­ing lym­phoma bi­o­log­i­cal­ly sim­i­lar to CLL in which too many im­ma­ture white blood cells cause lymph nodes to be­come larg­er than nor­mal.

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

Blue­bird bio $BLUE chief Nick Leschly court­ed con­tro­ver­sy last week when he re­vealed the com­pa­ny’s be­ta tha­lassemia treat­ment will car­ry a jaw-drop­ping $1.8 mil­lion price tag over a 5-year pe­ri­od in Eu­rope — mak­ing it the plan­et’s sec­ond most ex­pen­sive ther­a­py be­hind No­var­tis’ $NVS fresh­ly ap­proved spinal mus­cu­lar at­ro­phy ther­a­py, Zol­gens­ma, at $2.1 mil­lion. A Chica­go biotech, mean­while, has been fum­ing at the side­lines. In a law­suit filed ear­li­er this month, Er­rant Gene Ther­a­peu­tics al­leged that blue­bird and ven­ture cap­i­tal group Third Rock un­law­ful­ly prised a vi­ral vec­tor, de­vel­oped in part­ner­ship with the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter (MSK), from its grasp, and thwart­ed the de­vel­op­ment of its sem­i­nal gene ther­a­py.

In the in­creas­ing­ly crowd­ed check­point race, small cell lung can­cer has been a rare area where Roche, a sec­ond run­ner-up, has a lead over the en­trenched lead­ers Mer­ck and Bris­tol-My­ers Squibb. But Mer­ck is fi­nal­ly mak­ing some head­way in that di­rec­tion with the lat­est ap­proval for its PD-1 star.

The lat­est green light en­dors­es Keytru­da in the third-line treat­ment of metasta­t­ic SCLC, where it would be giv­en to pa­tients whose dis­ease ei­ther don’t re­spond to or re­lapse af­ter chemother­a­py, which would have fol­lowed at least one pri­or line of ther­a­py.

→  Rare dis­ease play­er Ul­tragenyx $RARE is ex­pand­ing its al­liance with Arc­turus $ARCT, pay­ing $24 mil­lion for eq­ui­ty and an­oth­er $6 mil­lion in an up­front as the two part­ners ex­pand their col­lab­o­ra­tion to in­clude up to 12 tar­gets. “This ex­pand­ed col­lab­o­ra­tion fur­ther so­lid­i­fies our mR­NA plat­form by adding ad­di­tion­al tar­gets and ex­pand­ing our abil­i­ty to po­ten­tial­ly treat more dis­eases,” said Emil Kakkis, the CEO at Ul­tragenyx. “We are pleased with the progress of our on­go­ing col­lab­o­ra­tion. Our most ad­vanced mR­NA pro­gram, UX053 for the treat­ment of Glyco­gen Stor­age Dis­ease Type III, is ex­pect­ed to move in­to the clin­ic next year, and we look for­ward to fur­ther build­ing up­on the ini­tial suc­cess of this part­ner­ship.”

The shock of Neil Wood­ford’s de­ci­sion to block with­drawals for his flag­ship fund is still rip­pling through the rest of his port­fo­lio — and be­yond. Un­der po­lit­i­cal pres­sure, UK fi­nan­cial reg­u­la­tors are now tak­ing a hard look while in­vestors con­tin­ue to flee.

In a re­sponse let­ter to an MP, the Fi­nan­cial Con­duct Au­thor­i­ty re­vealed that it’s opened an in­ves­ti­ga­tion in­to the sus­pen­sion fol­low­ing months of en­gage­ment with Link Fund So­lu­tions, which tech­ni­cal­ly del­e­gat­ed Wood­ford’s firm to man­age its funds.