Mer­ck’s key­stone im­munother­a­py Keytru­da has won yet an­oth­er lung can­cer ap­proval in Eu­rope, this time as the first line of de­fense for pa­tients with metasta­t­ic squa­mous non-small cell lung can­cer (NSCLC), on the ba­sis of tri­al da­ta that showed the drug — as part of a chemother­a­py com­bo — cut the risk of death by 36% ver­sus chemother­a­py alone.

The check­point in­hibitor is al­ready ap­proved as a monother­a­py or as part of a com­bo in var­i­ous forms of lung can­cer: as a front­line treat­ment in pa­tients with metasta­t­ic non­squa­mous NSCLC; first-line treat­ment in metasta­t­ic squa­mous or non­squa­mous NSCLC in adults whose tu­mors have high PD-L1 ex­pres­sion; and in lo­cal­ly ad­vanced or metasta­t­ic NSCLC in adults whose tu­mors ex­press PD-L1 and who have re­ceived at least one pri­or chemother­a­py reg­i­men.

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. With­in NSCLC, 40% of cas­es are ade­no­car­ci­no­mas, 25 to 30% are squa­mous cell car­ci­no­mas and 10 to 15% are large cell car­ci­no­mas. Over­all, the NSCLC mar­ket is poised to grow to $14.6 bil­lion by 2024, ac­cord­ing to Glob­al­Da­ta es­ti­mates.

The ap­proval was based on da­ta from KEYNOTE-407, a late-stage 559-pa­tient study eval­u­at­ing Keytru­da in com­bi­na­tion with car­bo­platin-pa­cli­tax­el or nab-pa­cli­tax­el com­pared with car­bo­platin-pa­cli­tax­el or nab-pa­cli­tax­el alone. The twin main goals are over­all sur­vival (OS) and and pro­gres­sion-free sur­vival (PFS).

Da­ta showed the Keytru­da com­bo sig­nif­i­cant­ly im­proved OS, re­duc­ing the risk of death by 36% com­pared to chemother­a­py alone (HR=0.64; p<0.0008) and im­proved PFS, with a re­duc­tion in the risk of pro­gres­sion or death by 44% com­pared to chemother­a­py alone (HR=0.56; p<0.0001).

The block­buster treat­ment, which takes the brakes off the im­mune sys­tem to bet­ter fight can­cer, is ap­proved for use in a pletho­ra of on­col­o­gy in­di­ca­tions in­clud­ing melanoma, head and neck can­cer, lym­phoma, urothe­lial car­ci­no­ma, gas­tric can­cer, cer­vi­cal can­cer, he­pa­to­cel­lu­lar car­ci­no­ma and Merkel cell car­ci­no­ma. It gen­er­at­ed about $7.2 bil­lion in sales last year for Mer­ck $MRK.

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.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.