FDA declines to grant Amgen’s Lumakras full approval in lung cancer after negative advisory committee vote

The FDA re­ject­ed Am­gen’s bid to con­vert Lumakras’ ac­cel­er­at­ed ap­proval in­to a full ap­proval in lung can­cer, the bio­phar­ma com­pa­ny an­nounced Tues­day morn­ing, and has asked the drug­mak­er to con­duct a new con­fir­ma­to­ry study to keep the prod­uct on the mar­ket.

The news is ex­pect­ed af­ter a pan­el of out­side ex­perts vot­ed 10-2 at an FDA ad­vi­so­ry com­mit­tee meet­ing in Oc­to­ber that the KRAS-tar­get­ed drug’s key da­ta could not be re­li­ably in­ter­pret­ed in a con­fir­ma­to­ry study in non-small cell lung can­cer.

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