No­var­tis paus­es en­roll­ment for Kisqali breast can­cer tri­als to align with ni­trosamine guide­lines

No­var­tis is tem­porar­i­ly stop­ping en­roll­ment of ear­ly breast can­cer pa­tients in­to clin­i­cal tri­als for Kisqali as it ad­justs to new reg­u­la­to­ry guid­ance on lim­its for ni­trosamines in drugs.

“We are im­ple­ment­ing man­u­fac­tur­ing ad­just­ments to en­sure align­ment with the lat­est reg­u­la­to­ry stan­dards in [ear­ly breast can­cer] by the end of Q2,” No­var­tis said in a Tues­day re­lease. Com­mer­cial sup­ply of Kisqali in metasta­t­ic breast can­cer re­mains un­af­fect­ed.

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