As­traZeneca is off to a good start in Au­gust. Af­ter its PARP in­hibitor Lyn­parza scored in a prostate can­cer tri­al ear­li­er this week, the British drug­mak­er on Fri­day dis­closed that its star can­cer drug Tagris­so helped pa­tients with a cer­tain type of lung can­cer live longer in a late-stage study.

The over­all sur­vival da­ta fol­lows pos­i­tive pro­gres­sion-free sur­vival da­ta un­veiled in 2017 from the FLAU­RA Phase III tri­al in­volv­ing pa­tients with metasta­t­ic epi­der­mal growth fac­tor re­cep­tor (EGFR) mu­ta­tion-pos­i­tive non-small cell lung can­cer (NSCLC). As­traZeneca es­ti­mates rough­ly 10-15% of pa­tients in the US and Eu­rope, and 30-40% of pa­tients in Asia have EGFR-mu­tat­ed NSCLC.

In the first half of 2019, Tagris­so was As­traZeneca’s $AZN biggest sell­er, rak­ing in $1.4 bil­lion in sales. The drug is cur­rent­ly ap­proved in 74 coun­tries, in­clud­ing the Unit­ed States, Japan and the EU for first line EGFR-pos­i­tive metasta­t­ic NSCLC.

The FLAU­RA tri­al as­sessed the ef­fi­ca­cy and safe­ty of Tagris­so oral­ly once dai­ly against com­para­tor treat­ments (ei­ther Tarce­va from Roche and Astel­las or Ires­sa from As­traZeneca’s own ar­se­nal) in 556 pa­tients across 29 coun­tries. Da­ta showed the drug near­ly dou­bled me­di­an pro­gres­sion-free sur­vival to 18.9 months ver­sus 10.2 months achieved by Tarce­va and Ires­sa.

On Fri­day, As­traZeneca said Tagris­so con­ferred a sta­tis­ti­cal­ly-sig­nif­i­cant and clin­i­cal­ly-mean­ing­ful im­prove­ment in over­all sur­vival — al­though de­tails will be pro­vid­ed at a lat­er date.

Lung can­cer is the lead­ing cause of can­cer death glob­al­ly, ac­cord­ing to the WHO. The two main types of lung can­cer are non-small cell and small cell, and NSCLC ac­counts for about 85% of all cas­es. Lung can­cer has a poor prog­no­sis; sta­tis­tics sug­gest over half of peo­ple di­ag­nosed die with­in one year of di­ag­no­sis and the av­er­age 5-year over­all sur­vival rate is less than 18%.

Con­sid­ered one of the most com­mer­cial­ly re­ward­ing con­di­tions to treat, As­traZeneca had pinned its hopes on the com­bi­na­tion of its check­point in­hibitor Imfinzi with its in-house CT­LA-4 drug in the keen­ly watched MYS­TIC tri­al ear­li­er this year, but that bet proved cost­ly. Imfinzi is now in de­vel­op­ment as a monother­a­py, as well as a chemother­a­py com­bi­na­tion, for lung can­cer pa­tients with­out a known ge­net­ic mu­ta­tion.

De­spite a string of high-pro­file miss­es, chief Pas­cal So­ri­ot has made strides in his mis­sion to fix As­traZeneca’s once-ail­ing port­fo­lio bruised by gener­ic med­i­cines eat­ing in­to sales. The com­pa­ny has since sharp­ened its fo­cus on the lu­cra­tive field of on­col­o­gy with drugs such as Lyn­parza, Tagris­so and Imfinzi. In 2016, So­ri­ot had tout­ed Tagris­so as a $3 bil­lion an­nu­al earn­er, a key fea­ture in his big promise to de­liv­er $45 bil­lion in an­nu­al rev­enue in 2023.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.